Strategies for Outreach and Education

Understanding Clinical Trial Barriers General Strategies for Educating Diverse Populations Specific Strategies for Educating Ethnically Diverse Populations Information on Other Underserved Groups References

Ways to Educate Yourself

Use NCI Resources Find Local Clinical Trials in Your Community Attend Conferences, Meetings, and Workshops

Ways to Educate Others, One-on-One

Get Started--Circle of Connections with Individuals Talk to Others--Tips Help Others Understand How to Evaluate Research in the News

Ways to Conduct Community Outreach and Education

Get Started--Circle of Connections with Groups Expand Your Organization's "Community" Prioritize-Develop a Strategy and Philosophy Use NCI Audiovisual Materials to Make Presentations Distribute Materials Write Articles for Local Newsletters and Web Sites Host an Information Session/Community Forum--A Step-by-Step Planning Guide Form an Advocacy Coalition

Ways to Work with the Media

Work with Mass Media--Goals, Timing, and Process Develop a Media Campaign Use Media Tools

Ways to Work with Hospitals, Medical Centers, and Universities

Work with Researchers and Health Care Professionals Serve on an Institutional Review Board (IRB)

Appendix

Plan for Action Resources

Introduction

Given your interest in clinical trials, it is likely that you already know quite a bit about how they work, the barriers associated with them, and why they are important.

Whether you are a health care professional who wants to find ways to reach your community, a member of a patient group who wants to educate its members, or someone who wants to engage your group or organization to initiate clinical trial outreach activities, this guide can help you figure out avenues to support your activities. The guide is not designed to be a comprehensive overview; rather, it gives some examples of activities others have engaged in, and provides tools and suggestions for implementation in your community.

By informing your community about clinical trials, you can help people make informed decisions about their cancer treatment or prevention options, including the option of participation in a clinical trial. The more people that participate in clinical trials, the faster we can answer the critical research questions that will lead us to better treatment and prevention options for all cancers.

This workbook is designed to complement the other materials in the National Cancer Institute Clinical Trials Education Series. ¹

Understanding Clinical Trial Barriers

It is important to understand the reasons why so few adults with cancer participate in clinical trials. A few are listed here.

Many people with cancer, or those at high risk for developing cancer, are:

• Unaware of the option of participating in clinical trials. Research has consistently shown that most people are not aware that clinical trials could be an option for cancer treatment or prevention.

• Unwilling to go against physician's advice or direction. Research has shown if a person's doctor does not recommend a trial as an option for cancer treatment or prevention, he or she is very unlikely to participate in one.

• Fearful, distrusting, or suspicious of research. For many people, the idea of being "randomized" to one treatment makes them feel they have less control over their care. Many are also fearful of being "experimented upon" and not receiving treatment for their cancer. Many people distrust those in the medical community, based on past negative experiences or the historical abuses of research participants.

• Unaware of clinical trials. The reality or the perception that there are no trials in their local community is a barrier for many people.

• Concerned about potential costs of trials. Some people who are insured fear that their insurance company won't cover participation in a clinical trial. Those who do not have insurance may worry about costs that are not covered by the trial's sponsor.

• Facing personal or practical obstacles. There are many costs, financial and otherwise, to participating in a clinical trial. Time and travel that are required to seek care at a distant trial site may be a concern for many people. The indirect costs of being away from work and family may also be a concern. Finally, some people may not wish to temporarily leave the care of their physician to participate in a trial.

Many doctors are:

• Unaware of clinical trials. Physicians are not always aware of available clinical trials. Some may not be aware of the local resources or may assume that none would be appropriate for the people they treat.

• Unwilling to "lose control" of patient's care. Most doctors feel that relationships with the people they care for are very important. They want what is best for each person. Some doctors fear that if a person must be referred elsewhere to participate in a trial, they may lose control of the person's care. They may not understand that every effort is made to maintain the physician relationship, even when a person is on a trial. In addition, many doctors may fear the loss of income if a person is referred elsewhere for his or her cancer care.

• Under the impression that standard therapy is best. Many physicians may not adequately understand how clinical trials are conducted or the importance of clinical research. Some physicians believe that the treatment in clinical trials is not as good as the standard treatment they might provide to people. They also may be uncomfortable admitting that there is uncertainty about which treatment is best in a phase 3 clinical trial.

Additional Clinical Trial Barriers for Ethnically Diverse Populations

• There is long-standing fear, apprehension, and skepticism in minority populations about medical research due to real abuses that have happened in the past (e.g., the legacy of the Tuskegee syphilis study). Among these populations, there is often widespread fear and distrust of the medical care system as a result of discrimination, indifference, and disrespect. Some may feel that they do not want to give up their rights by participating in a trial, or lose their power by being "experimented upon." Others may be skeptical about the quality of care that would be provided in a clinical trial. Some may find that trial recruitment strategies are not sensitive to their needs.

• Doctors may not mention clinical trials as an option for cancer care. As noted above, many physicians do not refer their patients to clinical trials. However, some physicians may avoid suggesting a clinical trial to their minority patients, out of concern that patients would see him/her as insensitive. Moreover, some physicians may unwittingly discriminate against older patients, or those who are from certain ethnic or cultural backgrounds.

• Many people may face additional problems accessing clinical trials. Depending on where they live or their access to transportation, people may have difficulty getting back and forth from a clinical trial site. Those with low income may find it difficult to take time off work or find appropriate childcare. Other barriers, such as a lack of health insurance or lack of general health care, clearly present difficulties in accessing trials.

• Cultural or ethnic backgrounds may include values and beliefs that are very different from Western Medicine. Many people have cultural beliefs that Western medicine cannot address their health concerns. Different ethnic and cultural views of health and disease (e.g., fatalism, family decisions about treatment, use of traditional healers, prayer, herbal medicines, or use of complementary/alternative health practices) may make clinical trials a less attractive treatment option. For prevention trials, many may feel that the risk of a potential disease and its consequences may be less important than meeting daily needs.

• Language and/or literacy barriers may make it difficult for some people to understand and consider participating in clinical trials. The complexity of forms, including informed consent documents, may also be a barrier to those considering participation in a clinical trial. Translation can also be difficult if the person translating information has not had specialized training.

General Strategies for Educating Diverse Populations

One of the biggest hurdles for clinical trial education is overcoming suspicion of medical research.

It is important to note that strategies for clinical trial outreach and education will vary, based on the type of trial and its requirements for participation. Although some of the following strategies were designed for cancer prevention trials, many may also be used for other types of clinical trials.

Strategy 1

Educators should be familiar (and preferably a part of) the communities they are trying to reach. People who are known, trusted, and accountable will be more effective and more believable when discussing clinical trials with community members.

Suggested Steps

• Use easy to understand language. In some cases this may mean using a community's first language.

• Involve people from the community, especially community leaders. Find ways to develop collaboration and encourage ownership in the outreach program.

Tip If you are not from the population(s) you seek to work with, it is critical that you or your organization develop meaningful collaborative partnerships with organizations within those communities.

Strategy 2

Address important concerns and perceptions, benefits, and risks about clinical trials through one-on-one contact. One-on-one contact is one of the best ways to educate others.

Suggested Steps

• Make sure you do not judge someone's values if they are different from your own. Find ways to present information that complement the values someone holds.

• Address risks and costs in a frank, open, and honest way.

• Stress the importance of enrollment in trials to the family and to future generations.

• Stress the importance of equal access to the highest quality care, including clinical trials. Each person has the right to know and understand every option available with regard to his or her health care.

• Promote the balance of spirituality, faith, medicine, and science.

• See the next section for suggested messages for specific ethnic/ racial groups.

Strategy 3

Discuss potential benefits of participating in a clinical trial; but do not overlook the risks.

Suggested Step

Discuss the fact that because people are monitored closely under clinical trial protocols, they often receive a higher quality of medical care and follow up than do those who are not enrolled in clinical trials.

Strategy 4

Avoid disrupting home and work schedules when conducting education or outreach activities.

Suggested Steps

• Hold meetings after church or other social activities.

• Suggest incorporating evening and weekend hours into required trial visits.

Key Points for Outreach and Education Clinical trial outreach strategies must incorporate an understanding of a potential participant's decision-making process, his or her culture, family and work life, and economic concerns. Those conducting education and outreach must find ways to present clinical trial information that complement the values people in the community hold. Education and outreach strategies should stress the importance of equal access to the highest quality care, including clinical trials. Each person has the right to know and understand every health care option available. Clinical trials must be explained in a way that is respectful and easy to understand, addresses someone's fears and concerns, and addresses risks and benefits. The research team must ensure that the informed consent process truly reflects a participant's understanding of the risks and benefits of the clinical trial. Involving family, members from the participant's community, and culturally competent staff are some ways to help verify that the participant has received the information in a way that he or she can understand and made the decision to participate voluntarily.

 

Specific Strategies for Educating Ethnically Diverse Populations

Research has shown that there are many differences in who gets cancer among people of different races, ethnicities, and socioeconomic backgrounds. Certain racial and ethnic groups, as noted on the pages that follow, are also more likely to die of cancer than other groups. These differences may be due to a variety of reasons, such as late stage of disease at diagnosis, barriers to health care access, history of other diseases, biologic and genetic differences in tumors, health behaviors, and the presence of other risk factors for cancer. In addition, some cancers that have a high rate of developing in one ethnic group are rare and may not be listed among the top 10 cancers in the U.S. population as a whole.* Because rare cancers may not receive as much attention as those in the "top 10," it is even more important for people of particular ethnic and cultural groups to be aware of research so that they can work to find ways to decrease the burden of these unusual cancers in their populations.

Differences in cancer screening and treatment have also been documented for people of different ages, as well as those from different socioeconomic, educational, and racial/ethnic backgrounds.

*Based on the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) Program. SEER is the most authoritative source of information on cancer incidence and survival in the United States.

Information on data sources used in this section: Cancer incidence data come from the NCI SEER program, covering 14 percent of the U.S. population. Cancer mortality data come from the National Center for Health Statistics (NCHS) and covers the entire U.S. population. Cancer incidence and death rates for some racial and ethnic populations may be limited by problems in ascertaining race and by the misreporting of race and ethnicity on forms used to collect information on cancer incidence, deaths, and the populations at risk. For instance, while reporting race for African-American and White populations is generally considered reliable, biases are more serious for smaller populations, particularly American Indian/Alaskan Natives, as well as for groups living in smaller geographical areas. Additionally, it is important to note that Hispanics can be of any race and are not mutually exclusive from White, African Americans, Asian/Pacific Islanders, and American Indian/Alaskan Natives. These biases can affect trends and comparisons among groups.

Ethnically Diverse Populations-Some Definitions

Diverse populations include minority, ethnic, and racial groups designated by the U.S. Government, including:

• American Indian or Alaska Native

• Asian American

• Black or African American

• Hispanic or Latin American

• Native Hawaiian or other Pacific Islander

Ethnically diverse populations are growing rapidly, and according to the 2000 Census, about 25 percent of the U.S. population reported their race as something other than White.

About 17 percent of the U.S. population over age 5 (more than 44 million people) do not speak English at home. Of these,

• Almost half speak English "less than very well"

• About 60 percent speak Spanish¹

NCI's working definition of diverse populations also includes medically-underserved populations, such as rural, low-income, and low-literacy level individuals of any racial or ethnic group. Medically underserved populations are those that lack easy access to, or do not make use of, high-quality cancer prevention, screening and early detection, treatment, or rehabilitation services. In general, these groups experience higher cancer death rates than the U.S. population as a whole.

Outreach Strategies

The strategies listed below are not meant to be a complete overview of barriers and strategies; nor should the information be generalized to all people in these groups. Attitudes within various populations vary greatly, depending on a person's age, socioeconomic status, community, and other factors. The broad outline here provides some background, context, and potential strategies for potential education and advocacy efforts.

Patient accrual for NCI-sponsored cancer treatment trials by sex and race/ethnicity ²

Percentage of estimated United States female population represented in NCI-sponsored cancer treatment clinical trials: log scale (by age and race/ethnic group)²

Percentage of estimated United States male population represented in NCI-sponsored cancer treatment clinical trials: log scale (by age and race/ethnic group)²

African Americans and Clinical Trials

Background

A person who is Black or African American has origins in any of the Black racial groups of Africa. This definition includes:

• Native-born Black Americans

• Africans

• Haitians

• Residents of non-Spanish-speaking Caribbean Islands of African descent

Cancer in African Americans

(Unless otherwise noted, all data is age-adjusted incidence or mortality rates between 1992 and 1999.)³

Overall, African Americans had the highest risk of any U.S. racial/ethnic group of not only getting cancer, but also for dying from cancer.

African American Men:

• Of all ethnic and gender groups, African American men have the highest overall rate of having cancer.

• Of all ethnic and gender groups, African American men have the highest overall rate of dying from cancer.

• Of all men, African Americans have the highest incidence and death rates from many cancers, including lung and bronchus, prostate, and colon and rectum cancer. In addition, in 2001, African American men were at least 50 percent more likely to get prostate cancer than were men of any other ethnic group.⁴

Top five cancers: Prostate, lung and bronchus, colon and rectum, oral cavity and pharynx, and stomach

African American Women:

• Of all women, African Americans have the highest incidence rates for colon and rectal cancer, lung and bronchial cancer, and pancreatic cancer.

• Of all women, African Americans have the highest death rates from many cancer, including breast, colon and rectal, pancreatic, uterine, and cervical cancers.

• While they have the second highest rates of all women of getting breast cancer, they have the highest rate of dying from the disease.

Top five cancers: Breast, colon and rectal, lung and bronchial, uterine, and pancreatic

Challenges

The legacy of the Tuskegee Syphilis Study (in which researchers studied but did not treat African American men with syphilis) has contributed to long-standing mistrust in African American communities concerning clinical research. Widespread skepticism about the medical care system exists as a result of a long history of discrimination, indifference, and disrespect. The oral history contributing to this mistrust is particularly important to recognize.

Some African Americans may believe that if they agree to participate in a trial, they will not be appropriately cared for, nor honestly informed of the risks or the benefits. They may fear that:⁵

• Placebos would be substituted for lifesaving interventions

• Treatments that work would be deliberately withheld

• They would not receive a full course of treatment, especially if funding sources for the clinical trial were no longer available

Other cultural beliefs and attitudes that affect research participation include hopelessness, fatalism, and doubt about the usefulness of cancer prevention and control. Faith, folk remedies, and the role of the family are other important influences for African Americans.⁶

Clinical trials may be a lower priority to African Americans and others who have a low income, less access to transportation and health care, less information about clinical trials, and low levels of literacy. Concerns about family and work responsibilities may also be a significant barrier.⁷ African American men have noted concerns about researchers not giving back to the community, being uncomfortable talking about prostate cancer, and past negative experiences with the medical care system.⁸

Potential Solutions

Cultural strategies:

• Find people who are already active in organizations to help spread the word about clinical trials. People who are known, trusted, and accountable in the community will be better messengers than will outsiders.

• Explore partnerships with African American churches, particularly for health issues central to the mission of the church. Faith is a very important part of many African American cultures and the most successful outreach efforts usually involve churches that have two or more paid clergy, and medium or large memberships.

• Ensure that the informed consent process truly reflects the participant's understanding of the risks and benefits of the clinical trial. Involving family, members from the participant's community, and culturally competent staff are some ways to help verify that the participant has received the information in a way that he or she can understand and made the decision to participate voluntarily.

Program strategies:

• Talk about trials using one-on-one contact-preferably with another African American person-through churches, schools, civic organizations, and African American sororities and fraternities. Word of mouth can be an effective way to reach others.

• Conduct in person outreach to complement other education efforts using videos, brochures, or advertisements.

• Present real-life situations that exemplify statistics or written messages. Effective dialogue can take place through a church-sponsored forum or an educational session that allows for open discussion and questioning.

• Involve local celebrities, including DJs at African American radio stations, by asking them to share messages about clinical trials.

• Ask newspapers and local media to join in education efforts.

• Provide personal, "real world" discussion of clinical trials and follow up in any education program.

Key Messages

Distrust of medical research is a critical issue, but it is important that African Americans be presented with an opportunity to find answers to research questions. The prospect of learning information that will help all people access treatment and better manage disease can be a powerful motivator.

Some African Americans may be more interested in clinical trials if they understand that participation means they:

• Contribute to their community and their families

• Join a group of people like themselves nationally, and in their local community

Clinical trial educational messages need to include information on the following topics:

• Severity of the cancer problem nationwide

• Underlying myth that African Americans don't need to be concerned about cancer

• Toll that cancer (especially breast and prostate) is taking on African American women and men-and that we don't know why

• Prevention and treatment options for high-risk African Americans-and the need for more research

• Importance of clinical trials-and what it means for all people if all groups are not represented in a trial

• Laws on participant protection and rights

• What risk means for the individual and others in his or her community

Asian Americans and Clinical Trials

Background

A person who is Asian has origins in any of the original peoples of the Far East, Southeast Asia, and Indian subcontinent. The term "Asian" refers to persons from the following and other Asian, Southeast Asian, and South Asian backgrounds:

Chinese Vietnamese Pakistani Filipino Cambodian Thailandian Japanese Hmong Indian

Korean Laotian Bangladeshi Indonesian Sri Lankan Nepalese Bhutanese Sikh Burmese

"Asian Americans" and "Pacific Islanders" are two discernibly distinctive groups, comprised of numerous heterogeneous ethnic subpopulations. These broad categories fail to show mortality rates that, in some instances, strongly differ among ethnic groups. Whenever possible, this publication separates out these groups.

U.S. residents who reported they were Asian* make up 4.2 percent of the total population. Chinese is the leading Asian group (2.7 million) followed by Filipino (2.4 million) and East Indian (1.9 million).¹

*Self report, alone or in combination with one or more other races

The Asian population includes many groups who differ in language, culture, and length of residence in the United States. Some of the Asian groups, such as the Chinese and Japanese, have been in the United States for several generations and often have literacy, education, and socioeconomic characteristics that are above the national average. On the other hand, groups such as the Hmong, Vietnamese, Laotians, and Cambodians are comparatively recent immigrants, and tend to have limited acculturation and poverty rates below the national average. It is important to note that 88 percent of Asian Americans and Pacific Islanders (AAPI) are either foreign-born themselves or have at least one foreign-born parent. Of those who speak Asian and Pacific Island languages at home, more than 22 percent say they speak English "not well" or "not at all."¹

Cancer in Asians

(Unless otherwise noted, all data is age-adjusted incidence or mortality rates between 1992 and 1999).)³

Some Asians are much more devoted to traditional medical practices than to Western medicine. For example, a study of breast and cervical cancer screening in Chinese women found that more than 2/3 had gone to traditional providers for preventive health care, went to temples to pray for their health, and looked to fortune-tellers for guidance.⁹ Another study of cervical cancer screening in Cambodian women indicated beliefs that fate cannot be changed by detection, cancer is incurable, and cancer will not develop if traditional practices are used.¹⁰

Like the Hispanic/Latino populations, Asian/Pacific Islanders experience lower incidence and mortality rates overall compared with other minority groups. However, they do experience higher incidence and mortality rates for certain cancers. Based on three-year averages, more than 18 percent of Asian and Pacific Islanders lack health insurance.

Asian/Asian Pacific Islander men:

• Of all men, AAPIs have the highest incidence rates of liver and stomach cancer.

• Of all men, AAPIs have the highest death rates from liver cancer.

Asian/Asian Pacific Islander women:

• Seventy percent of Asian Americans come from countries with the world's lowest overall rates of breast cancer, yet after living in the U.S. for as little as 10 years, Asian women have an 80 percent higher risk of getting the disease than recent immigrants.

• In addition, third and fourth generation Asian American women have rates of developing breast cancer that are similar to their neighboring Caucasian women.¹¹

• Asian American women in general have the lowest rates of Pap test, mammogram, and breast exam screening of any ethnic group.^6,11

• Of all women, Asians have the highest rates of liver and stomach cancer.

• Of all women, Asians have the highest death rates for liver and stomach cancer.

Cancer in Specific Asian Groups The NCI SEER cancer incidence rates noted in this publication are available for different levels of racial/ethnic detail in each of the time periods (1988-1992 and 1992-1999). Although the SEER program routinely collects detailed racial/ethnic information on the cancer patients in its coverage areas, the lack of comparable detail in the racial/ethnic county-level population estimates from the U.S. Census Bureau means that incidence rates for certain racial/ethnic groups can be calculated only for time periods centered on the decennial census. For example, county-level census information for Asian and Pacific Islanders by subgroups (Chinese, Filipinos, Hawaiians, etc.) is still only available from the 1990 Census.

From 1988 to 1992, Chinese, Japanese, Korean, and Vietnamese* groups all had higher rates of getting liver and intrahepatic bile duct (IHB) and stomach cancers than Whites, and Chinese and Japanese had higher mortality than Whites from these two cancers, as well.¹² In this same time period, Korean and Vietnamese women had higher incidence rates of cervical cancer than White women.¹²

*Liver and IHB not calculated for Vietnamese women

From 1988 through 1992, the top five cancers for many Asian groups are as follows:¹²

Women:

Men:

Challenges

Values in many Asian cultures may be different than the Euro-American system, with decisions reached by consensus, group welfare being of primary value, and individual life not as sacred.⁶ In some Asian cultures, the family is responsible for treatment decisions and the patient is not told of his or her diagnosis.

Many in the Asian immigrant communities need a lot of support as they learn about clinical trials, and they need to feel safe asking questions. "Saving face" in public is important. In many cases, Asian immigrants may feel it is disrespectful to ask questions of doctors or health professionals.

Recent immigrants also may be dealing with a combination of educational, social, and health problems, along with emotional difficulties related to separation and isolation. Many are in low-wage jobs and need to get permission to take time off work to take care of health care needs.

The language barrier also is difficult to overcome. Many Asians do not speak English, and this may not be readily apparent. There are so many Asian languages that deciding on the language(s) in which information should be printed is difficult. This barrier is particularly important in issues surrounding informed consent. The informed consent process is intimidating for all people and is especially so for those with limited English skills.

Potential Solutions

Cultural strategies:

• Assess how long the group you are trying to reach has been in this country as well as the countries of origin represented. It is important to fit the educational outreach to the culture and to use people from the communities to reach community members.

• Involve family members in learning about the risks and benefits of clinical trials, but resist using them as translators of medical information. In particular, avoid having children-who may be more proficient in English than their parents-serve as translators. It is preferable to enlist someone who is trained for this work.

• Ensure that the informed consent process truly reflects the participant's understanding of the risks and benefits of the clinical trial. Involving family, members from the participant's community, and culturally competent staff are some ways to help verify that the participant has received the information in a way that he or she can understand and made the decision to participate voluntarily.

Language strategies:

• Find respectful ways to make sure that information is being understood. Someone who does not understand English may say "yes" or nod, even if they do not understand what is being said. To ensure that the person you are talking with understands what you have said, staff may ask, "Many people have a hard time understanding information like this. I want to make sure that I explain it clearly. Could you please tell me, in your words, what I have just said."

• When translating materials, at least two bilingual, bicultural translators should be used. In addition, materials should be pilot-tested with the target audience.

Program strategies:

• Use health fairs, which have been successful when organized by community members, and involve the leadership of existing Asian groups in clinical trial outreach.

• If possible, translate clinical trial information to be used in ethnic newspapers. Many immigrant groups get their health information from press that is printed in their own languages.

• Invite a professional to deliver information about clinical trials. Preferably, a doctor or nurse from that community should be invited, who can encourage others to ask questions. Often, laypeople do not have much credibility as an information source.

• Keep workshops or programs short (30 to 40 minutes) because many new immigrants have more than one job, in addition to other responsibilities.

• While recent immigrants may not have been concerned with breast cancer in their countries of origin, it is important to educate these women about their increased risk for this disease.

Key Messages

• A family's receptivity to cancer treatments and trials will depend on the experience that relatives have had with the medical system. For example, if a relative did not survive cancer, it may be taboo to talk about him or her.

• Remember to consider feminine modesty and traditional gender role values.

Native Hawaiians and Other Pacific Islanders and Clinical Trials¹³

Native Hawaiians and Pacific Islanders are often aggregated nationally into the "Other" category or currently the "Asian American/Pacific Islander or AAPI" category. It is important to note that these are two discernibly distinctive groups, comprised of numerous heterogeneous ethnic subpopulations. These groupings have obscured disparate mortality rates that are prevalent in one group and not the other. Whenever possible, this publication separates out these groups.

Background

Native Hawaiians and other Pacific Islanders of Polynesian, Micronesian, and Melanesian ancestry* made up 0.3 percent of the total U.S. population.¹ This group comprises more than 25 diverse groups with variations in historical backgrounds, languages, and cultural traditions.

*Alone or in combination with one or more races.

Among Pacific Islanders in the United States, Native Hawaiians are the largest group, 58 percent (211,014). Three-fourths of Pacific Islanders live in the states of California and Hawaii and they are a relatively young population, with a median age of 25 years and an average family size of 4.1.

The term "other Pacific Islanders," refers to the peoples of Polynesia, Micronesia, and Melanesia, and includes:

Chamorros Samoans Fijians Tongans Tahitians Marshallese

Chuukese Kosraen Yapese Pohnpeian Palauan Other Pacific Islanders

Within this group are six U.S.-associated Pacific Island jurisdictions--the Federated States of Micronesia, the Republic of Palau, the Republic of the Marshall Islands, Guam, American Samoa, and the Commonwealth of the Northern Marianas-that have various political relationships with the U.S.

The population of the U.S.-associated Pacific Island jurisdictions is approximately 427,000. The health status varies within and among the jurisdictions, but is generally worse than for Americans. The jurisdictions must contend with health conditions found in both developing countries (e.g., malnutrition, dengue fever, cholera, and tuberculosis) and developed countries (e.g., diabetes, heart disease, and cancer).

Cancer in Native Hawaiians

Hawaiian Men:

(For the years 1988-1992)¹²

• Have the second highest cancer mortality, behind only African Americans

• Of all men and of all ethnic groups,

• Have the highest cancer mortality for non-Hodgkin's lymphoma

• Have the second highest rates for cancers of the lung and bronchus and pancreas

Top five cancers: Lung and bronchus, prostate, colon and rectum, stomach, and non-Hodgkin's lymphoma

Hawaiian Women:

(For the years 1988-1992)¹²

• Are tied with African Americans for the second highest cancer mortality (second only to Alaska Natives).

• Of all women and all ethnic groups:

  • Have the highest death rate for cancers of the stomach and uterus

  • Have the second highest incidence rates for cancers of the lung and bronchus

Top five cancers: Breast, lung and bronchus, colon and rectum, uterine, and stomach

Cancer in Pacific Islanders

Cancer surveillance and databases are rudimentary or non-existent in most of these jurisdictions, rendering cancer rates unknown. What is known is that cancer is among the top three causes of death. The most commonly reported cancers for males were cancers of the lung and prostate, and for females, cancers of the breast, cervix, and lung.

Challenges

• A history of oppression, higher prevalence of behavioral risk factors, ineffective cancer prevention and control efforts, and poor access to state-of-the-art services for cancer prevention, early detection, and treatment (including low representation in clinical trials) contribute to increased cancer risk and mortality among Native Hawaiians and other Pacific Islanders.

• Many Native Hawaiians and Pacific Islanders are socio-economically disadvantaged and underserved in terms of access to health and social services.

• In the U.S., many Pacific Islanders do not speak English at home.

• There is a general distrust of research among island communities. This distrust can also have negative consequences for those participating in a trial, such as poor compliance or avoidance.

• Geographic barriers are a problem for many Pacific Islanders; clinical trials are unavailable for most Western Pacific and Samoan communities and rural Hawaiian communities.

• The conduct of many clinical trials lacks cultural sensitivity and does not address language needs; it also does not interpret cultural behaviors and preferences.

Potential Solutions

Cultural strategies:

• Tailor the educational outreach to the culture and use "cultural brokers" (members of the community) to reach other community members.

• Include the family unit, which for many Native Hawaiians and Pacific Islanders includes extended family members and friends, when educating about the risks and benefits of clinical trials. The role of the woman is central to the family in many Pacific Island cultures.

• Ensure that the informed consent process truly represents the participant's understanding of the risks and benefits of the clinical trial. Involving family, members from the participant's community, and culturally competent staff are some ways to help verify that the participant has received the information in a way that he or she can understand and made the decision to participate voluntarily.

Program strategies:

• Use personal contacts through a family member or a friend to do education and outreach.

• Explain the benefits of research to the community at large.

• Address issues of medical care that are not covered by clinical trials, as these are an important concern for participants who may not have insurance or are underinsured.

Native Americans and Clinical Trials^14,15

Background

A person who is considered Native American has origins in any of the original peoples of North or South America (including Central America) and maintains tribal affiliation or community attachment.

The term "Native American" refers to:

• American Indians

• Alaska Natives:

  • Aleuts

  • Eskimos

Native Americans are made up of culturally distinct and diverse communities. The U.S. contains 511 federally recognized tribes, with Native American people living in every State. The largest tribes are Cherokee and Navajo. More than 9 percent of the U.S. population reported American Indian or Alaska Native status in the 2000 Census.

Indian Health Service

There are more than 300 hospitals and health clinics, located on or near Indian reservations, run by the Indian Health Service (IHS). In recent years, many tribes have assumed management of some of these health care facilities.

The Indian clinics and hospitals are unable to provide the high-tech medical care needed to diagnose and treat cancer. For this reason, the IHS Contract Health Services program pays for Indian health care provided by non-IHS providers. However, this program is chronically short of funds. Depending on the region/tribe, its local priorities, and funding remaining in the service contract, certain treatments may not be available. At present the Contract Health Services does not reimburse for many treatments that are deemed "experimental," which keeps many Indian people out of clinical trials.

Although 54 percent of Native Americans live in urban areas, less than 2 percent of the IHS budget is spent in urban clinics.⁶ These clinics are severely underfunded and must rely on other sources of support, including Medicaid revenue. Many urban Indians choose to return to their home reservations for care.

Based on 3-year averages, American Indians and Alaska Natives were the least likely of the major racial groups to have health insurance.^1A

Cancer in Native Americans

(Unless otherwise noted, all data is age-adjusted incidence or mortality rates between 1992 and 1999.)³

While American Indian/Alaska Natives experience some of the lowest cancer rates among all ethnic groups, they do experience higher incidence and mortality for certain cancers. Cancer is the second leading cause of death among Native Americans and is the leading cause of death among Alaska Native women.^16,17

American Indian/Alaska Native Men:

• Of all men and all ethnic groups, have the highest mortality rate for kidney and renal cancer

Top five cancers: Prostate, lung and bronchial, colon and rectal, kidney and renal pelvis, and stomach

American Indian/Alaska Native Women:

• Have the highest incidence rate of gallbladder cancer

• Have the highest mortality rate for kidney and renal cancer

Top five cancers: Breast, colon and rectum, lung and bronchial, uterine, and ovarian

Alaska Natives (For the years 1988-1992)12 Alaska Native men had the highest rates of getting colon and rectal cancer among all ethnic groups. In this same time period, Alaska Native women had the highest rates for getting and dying from colon, rectal, and lung cancer among ethnic groups, and their rates of getting cervical cancer were twice as high as those for White women. The top cancers: Men: Lung and bronchus, colon and rectum, prostate, and stomach Women: Breast, colon and rectum, lung and bronchus, and cervical American Indians (Living in New Mexico) American Indian men had the highest rates of all ethnic groups of getting kidney cancer. In this same period, American Indian women had higher rates of cervical and ovarian cancers than the U.S. White female population. Top cancers in American Indians: Men: Prostate, colon and rectal, kidney and renal pelvis, and lung and bronchus Women: Breast, ovarian, colon and rectal, gallbladder, and uterine

Challenges

• A history of disrespect, racism, and poverty has contributed to a distrust of science and research by Native American populations. To protect the interests of Native American people, many tribes have their own Institutional Review Board (IRB), in addition to those required by Indian Health Service (IHS) or tribal facility. Successful clinical trial outreach requires that the investigator work closely with the tribal IRB in addition to those of the IHS.

• Native Americans are a culturally distinct and diverse community and their beliefs about cancer, and experiences with diabetes, alcoholism, poverty, and traditional roles can significantly affect the success of clinical trial educational programs.

• On average, Native Americans are younger, have a lower rate of high school completion, and have higher rates of poverty and unemployment than Whites.⁶

• Many Native people do not have access to quality health care.

• Many tribes do not have a word for cancer in their languages and historically, the disease was thought of as something that affected only the "White man." Some Native Americans may hold a fatalistic attitude toward cancer, and fear that if they talk about cancer or even think about it, they might catch it.

• It is unlikely that Native Americans would participate in a cancer trial without hearing messages from other Native Americans, yet there are few cancer survivors to serve as role models.

• Informed consent forms and procedures may serve as a barrier to recruitment because the language used in such forms may not be well understood.

• Because of other pressing health issues, such as diabetes, obesity, and substance abuse, in addition to extreme poverty, cancer screening and treatment may not be as important to some Native people.

• There may be a tribal taboo on the loss of body parts that needs to be discussed in relation to clinical trials.

• Transportation is an important barrier for Native Americans who live in rural areas.

• Differences in communication styles are important to consider. Many Native Americans are reserved, reluctant to ask questions, or don't discuss their health problems. Body language also is important, with respect for personal space and friendly gestures such as smiling and eye contact being key.

• Traditional roles are such that women are usually caretakers and often place their needs last. In addition, Native American women value modesty and privacy, and many traditional Native American couples find a male health care provider for the woman unacceptable.

Potential Solutions

Cultural strategies:

• Use group activities such as sharing and caring for others because they are universal concepts among Native people, and should be a part of any clinical trial education program.

• Incorporate the use of traditional healing ceremonies as well as spiritual connections, which can be very important for people in these communities.

• Family plays a central role in American Indian life. The needs of the family may take precedence over the needs of the individual. When appropriate, the patient's family should be involved in the decision-making process.

• Ensure that the informed consent process truly represents the participant's understanding of the risks and benefits of the clinical trial. Involving family, members from the participant's community, and culturally competent staff are some ways to help verify that the participant has received the information in a way that he or she can understand and made the decision to participate voluntarily.

Language strategies:

• Use easy-to-understand language and a gentle approach to education and outreach. Try to include materials that portray Native Americans.

• Make sure that patient consent forms are understood. Reading out loud or encouraging consultation with others may be important.

Program strategies:

• Emphasize that participation in a trial can help improve cancer care for the next generation.

• Use stories and visual tools that focus on the family.

• Use one-on-one or small group education and outreach techniques to respect privacy.

• Work with community or tribal elders such as community health representatives and public health nurses, to find out the best ways to conduct outreach and education efforts.

• Find out if transportation is needed to get to the site.

• Use public service announcements on Native American radio.

Key Messages

• Messages should be culturally relevant and discuss issues related to family and community.

• Tribal beliefs are very diverse and programs should be designed on a site-specific basis with the help of tribal advisors.

Hispanics and Clinical Trials

Background

The terms "Hispanic" and "Latino" refer to people born in North, Central, and South America, and in the Caribbean whose language is Spanish. Someone who is Hispanic or Latino is a person of Mexican, Puerto Rican, Cuban, Central or South American, or other Spanish culture or origin, regardless of race.

In the mainland United States today the largest groups within the Hispanic community are:

• Mexican (58.5%)

• Puerto Rican (9.6%)

• Central American (4.8%) (Salvadorian, Guatemalan, Honduran, Nicaraguan, Panamanian, and other people from countries in Central America)

• South American (3.8%) (Colombian, Ecuadorian, Peruvian, Argentinean, Venezuelan, Chilean, and other people from countries in South America)

• Cuban (3.5%)

The Hispanic population is the fastest growing ethnic group in the U.S. In the 2000 Census, Hispanics eclipsed African Americans to become the second largest ethnic group, with 12.5 percent of the population reporting Hispanic or Latino status. Hispanics as a group comprise many different races and ethnicities. Within these subpopulations, other differences exist according to culture, beliefs, lifestyles, and experiences, but Hispanics agree that certain commonalities go beyond specific nationalities. In general, the U.S. Hispanic population is younger, with more people per household, and has lower rates of employment, less education, and lower economic status than do Whites.⁶

There are 28 million U.S. residents aged 5 and older who speak Spanish at home-about 10 percent of the U.S. population. These percentages vary greatly throughout the United States; for example, states like California, Texas, and New Mexico, have approximately 30 percent of residents who speak languages other than English.¹ Among all those who speak Spanish at home, almost half speak English "less than very well." It is important to note that in 2000, 68 percent of the U.S. population is foreign-born or had at least one parent who was foreign-born.¹

Cancer in Hispanics*

(Unless otherwise noted, all data is age-adjusted incidence or mortality rates between 1992 and 1999.)³

*"Hispanic" is not mutually exclusive from Whites, African American, Asian/Pacific Islanders, and Native Americans.

Although Hispanics had the largest reduction in cancer mortality rates of any U.S. ethnic group (-1.6 percent) they also had the greatest number of uninsured people. Based on three-year averages, more than 33 percent of all Hispanics lack health insurance coverage.^1a A recent study showed that uninsured Hispanic women are more than two times more likely to be diagnosed with breast cancer at a later stage than other women, and uninsured Hispanic men are almost four times more likely to be diagnosed with a later stage of prostate cancer than non-Hispanics.¹⁹

While Hispanics/Latinos have lower incidence and death rates overall compared with those of African Americans and Whites, they do experience higher rates for certain cancers.

Latino/Hispanic men:

• Have the third highest incidence and death rates for prostate cancer

Top five cancers: Prostate, lung and bronchus, colon and rectal, non-Hodgkin's lymphoma, and stomach

Latina/Hispanic women:

• Have the highest incidence rates for cervical cancer and the second highest death rate from the disease.

Top five cancers: Breast, colon and rectal, lung and bronchus, cervical, and uterine

Challenges²⁰

• Many Hispanics have strong religious and cultural beliefs. Some may believe strongly in "fatalismo" (fatalism) and "resignación" (resignation)-that diseases or illness cannot be controlled because they are inherited.

• Many may use folk remedies [such as "uña de gato"(cat's nail)] to treat cancer or wait until they are in serious pain to see a doctor.

• In one study, barriers that were identified by Latinas considering a cervical cancer trial included transportation, fear of getting a placebo, care of children and family, and care from a male provider.⁷

• Although Spanish is one language, regional dialects need to be considered when translating materials.

• The language barrier is particularly important in issues surrounding informed consent. The informed consent process is intimidating for all people and is especially so for those with limited English skills.

• Some Hispanics think that cancer treatment will only prolong life but that no effective cure exists for the disease. Even if people are treated, it is felt that the type of treatment depends on the person's ability to pay.

• Hispanics may not obtain health care until they are very sick and cannot perform normal functions. This adds to the number and severity of health problems that need to be evaluated. However, women are more likely than men to seek medical care.

• Many in the Hispanic community feel that doctors do not communicate well with them and they do not feel well informed about trials. Many hold the perception that doctors may have financial interests in a trial, and there is a lack of trust around participating in scientific research.

• A sense of fatalism and resignation is usually strongest in women and older men. This may make people feel that treatment is useless.

• Machismo is a barrier because men feel they are the family protectors and should not show weakness.

• Hispanics' biggest barriers to accessing health care are money, time, and language. Other common problems include lack of insurance, problems with transportation or childcare, and getting off work to see a doctor.

• Although face-to-face interaction is important, Hispanics would not welcome unknown health educators or volunteers into their homes. Men lack trust in a Federal Government source, while most women tend to trust it.

Potential Solutions

Cultural strategies:

• Collaborate with people who are from the communities and speak Spanish. Community members can identify with people who have a direct tie to their situation. Personal interaction is very important. Testimonials from local pastors, Hispanic celebrities, or doctors who have experienced cancer themselves are beneficial.

• Involve family members in learning about the risks and benefits of clinical trials. Sometimes children have learned to speak English more quickly than their parents, so they can be helpful in translating forms and brochures. It is important to note, however, that using children as translators has both pros and cons. It is preferable to use someone who is trained for this work.

• Ensure that the informed consent process truly reflects the participant's understanding of the risks and benefits of the clinical trial. Involving family, members from the participant's community and culturally competent staff are some ways to help verify that the participant has received the information in a way that he or she can understand and made the decision to participate voluntarily.

Language strategies:

• Find respectful ways to make sure that information is understood. When people do not understand English, they may say "yes" or nod, even if they do not understand what is being said. To ensure that the person you are talking with understands what you have said, staff may ask, "Many people have a hard time understanding information like this. I want to make sure that I explain it clearly. Could you please tell me, in your own words, what I have just said?"

• When translating materials, at least two bilingual, bicultural translators should be used. In addition, materials should be pilot-tested with the target audience.

Program strategies:

• Take the outreach program out to community and neighborhood centers as well as to other sites that are already familiar to Hispanics. Consider partnering with existing groups.

• Use family-oriented, positive messages as much as possible to offer hope.

• Use radio and newspapers for outreach. Spanish-language media-especially television and radio talk shows-are popular sources of health-related information for many in these communities. Printed materials with many pictures/illustrations and minimal text are preferred.

Information on Other Underserved Groups

Older Adults

When considering older people and clinical trials, it is important to note that approximately 60 percent of all cancers occur in people aged 65 and older, and the number of people over age 65 is expected to double by the year 2033. The elderly are an important group to participate in clinical trials.

Because of mobility problems, transportation (including escort assistance) is one of the most important challenges specific to older people. Literacy issues (see below) are also a challenge that must be addressed when educating older adults.

Fostering positive doctor-patient interaction is another difficulty because often the older population is reluctant to question or challenge doctors and may be afraid to offend by changing doctors. This is compounded when doctors do not refer older adults to trials because of the assumption that they are too old or sick for a trial.

Older persons are more likely to be living on fixed incomes, so the financial aspects of clinical trial participation may be heightened.

The family, or other social support, is another important consideration because it is often involved in the older person's treatment and decision-making process.

It is important to inform older adults that Medicare reimburses for all routine care costs for its beneficiaries participating in clinical trials.

People with Low Literacy Skills¹⁹

"Many Americans face the serious problem of not being able to read or understand information. According to the 1992 National Adult Literacy Survey (NALS), some 40 to 44 million of the 191 million adults in the United States are functionally illiterate. Another 50 million are only marginally literate. Functional literacy represents more than just the ability to read. It involves reading comprehension as well as the ability to compute, communicate, write, and solve problems. These skills are especially important for patients in acquiring general information and applying it to their specific circumstances."

"When applied to the health system, low functional literacy translates into low health literacy. Health literacy is defined as the ability to obtain, interpret, and understand basic health information and services, as well as competence and motivation to use such information and services in ways that enhance one's health. Most health-related educational materials use simplified printed materials to convey information, assuming that people can read. Most adults do read, but many have difficulty understanding what they read and applying generalized information to their own specific situation."

"One common assumption is that certain populations have low levels of functional literacy. For example, traditionally "underserved" populations such as those with low incomes are labeled as having low levels of functional literacy simply because they are, on average, less educated. However, low functional literacy is not defined by race, class, or even educational attainment."

Ways to Help People with Low Health Literacy Skills

"One-on-one assistance is the most effective technique for educating this group. In addition to helping people gain a better understanding of the clinical trial and their health needs, one-on-one assistance fosters trust between patients and the counselors or health care professionals who help them. Comprehension should be ascertained, but not by asking, "Do you understand?" Often the "teach back" method works well."

"Group assistance offers an arena in which people can obtain information from educators and through the questions asked by others in the group. This technique often supplements one-on-one counseling."

"Visual tools are designed to simplify concepts such as instructions for care that are too complicated to understand in written form or through verbal communication. Visual tools are particularly useful to those who cannot read at all. Videotapes may be useful tools, but follow up discussion is necessary in order to ascertain comprehension."

Lesbian, Gay, and Bisexual Individuals

The lesbian, gay, and bisexual (LGB) community is diverse in terms of cultural background, ethnic or racial identity, age, education, income, rejection or acceptance of societal stereotypes, and prejudice. As with other minority groups, discrimination and bias can play a role in inadequate medical assessment, treatment, and prevention of LGB health problems. In addition, lesbians may be at a greater risk of cancer because of issues associated with health care access, delayed or lack of childbearing, screening, and insurance.

Little information is available about specific clinical trial barriers for the LGB population. Significant barriers that must be addressed include:

• Previous negative health care experiences

• Fear of sexual orientation disclosure

• Perceived or actual exclusion from health promotion campaigns

• Misinformation about risks and screening

• Exclusion of significant others

References

1. U.S. Census Bureau. U.S. Department of Commerce, Census 2000. Available at http://www.census.gov

1a. U.S. Census Bureau. U.S. Department of Commerce Health Insurance Coverage: 2001 Issued September 2002. Available at http://www.census.gov

2. Sateren, W. B., Trimble, E. L., Abrams, J., Brawley, O., Breen, N., Ford, L., McCabe, M., Kaplan, R., Smith, M., Ungerleider, R., Christian, M. C. (2002). How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. Journal of Clinical Oncology Apr 15;20(8):2109-17.

3. Edwards, B.K., Howe, H.L., Ries, L.A.G., Thun, M.J., Rosenberg, H.M., Yanick, R., Wingo, P.A., Jemal, A., Feigal, E.G. (2002). Annual report to the nation on the status of cancer, 1973-1999, featuring implications of age and aging on the U.S. cancer burden. Cancer May 15;94(10):2766-2792. http://seer.cancer.gov

4. American Cancer Society. (2002). Cancer facts and figures 2002.

5. Roberson, N. L. (1994). Clinical trial participation: Viewpoints from racial/ethnic groups. CANCER Supplement, 74(9), 2687-2691.

6. Guilano, A. R., Mokuau, N., Hughes, C., Tortolero-Luna, G., Risendal, B., Ho, R. C. S., Prewitt, T. E., & McCaskill-Stevens, W. J. (2000). Participation of minorities in cancer research: The influences of structural, cultural, and linguistic factors. Annals of Epidemiology, 10(8), S22-S34.

7. Brown, D.R., Fouad, M. N., Basen-Enguist, K., & Tortolero-Luna, G. (2000). Recruitment and retention of minority women in cancer screening, prevention, and treatment trials. Annals of Epidemiology, 10(8), S13-S21.

8. Royal, C. D., Baffoe-Bonnie, A., Kittles, R., Powell, I., Bennett, J., Hoke, G., Pettaway, C., Weinrich, S., Vijayakumar, S., Ahaghotu, C., Mason, T., Johnson, E., Obeikwe, M., Simpson, C., Mejia, R., Boykin, W., Roberson, P., Frost, J., Faison-Smith, L., Meegan, C., Foster, N., Furbert-Harris, P., Carpten, J., Bailey-Wilson, J., Trent, J., Berg, K., Dunston, G., & Collins, F. (2000). Recruitment experiences in the first phase of the African American hereditary prostate cancer (AAHPC) study. Annals of Epidemiology, 10(8), S68-S77.

9. Lee, M. (1999). Breast and cervical cancer early detection in Chinese American women. Asian-American Pacific Islander Journal of Health, 6, 358-367.

10. Taylor, V., Jackson, J., Schwartz, S., Yasui, Y., Tu, S., & Thompson, B. (1999). Cervical cancer control in a Cambodian American population. Asian-American Pacific Islander Journal of Health, 6, 368-377.

11. Shinagawa, S. M., Kagawa-Singer, M., Chen, M. S., Tsark, J. U., Palafox, N. A., & Mackura, G. (1999). Cancer registries and data for Asian Americans and Native Hawaiians and Pacific Islanders: What registrars need to know. Journal of Registry Management, 26(4), 128-141.

12. Miller, B.A., Kolonel, L.N., Bernstein, L., Young, Jr., J.L., Swanson, G.M., West, D., Key, C.R., Liff, J.M., Glover, C.S., Alexander, G.A., et al. (Eds). (1996). Racial/ethnic patterns of cancer in the United States 1988-1992 (NIH Publication No. 96-4104). Bethesda, MD: National Cancer Institute.

13. Papa Ola Lokahi. (May 1, 2001). Personal communication. Honolulu, HI and Tsark, J.U. (1998). Cancer in Native Hawaiians. Pacific Health Dialog, 5, 315=327.

14. Hodge, F. S., Weinmann, S., & Roubideaux, Y. (2000). Recruitment of American Indians and Alaska Natives into clinical trials. Annals of Epidemiology, 10(8), S41-S48.

15. Burhansstipanov, L. (Director, Native American Cancer Research Corporation). (April 2001). Interview. Pine, CO.

16. U.S. Department of Health and Human Services. (1997). Regional differences in Indian health. Rockville, MD: Indian Health Service.

17. Lanier, A. P., Holck, P., Kelly, J., Smith, B., & McEvoy, T. (1999). Alaska Native cancer survival report. Anchorage, AK: Alaska Native Health Board.

18. U.S. Census Bureau. US Department of Commerce, Health Insurance Coverage, by Selected Characteristics: Issued October 1999. Available at http://www.census.gov

19. American College of Physicians-American Society of Internal Medicine. (2000). No health insurance? It's enough to make you sick. Latino community at great risk. Philadelphia: Author. Available: American College of Physicians-American Society of Internal Medicine, 190 N. Independence Mall West, Philadelphia, PA, 19106.

20. National Cancer Institute. (1996). Communicating with Hispanic cancer patients: A focus group study. Washington, DC: Author.

21. Center for Medicare Education. (2000). Considering health literacy. (Issue brief, volume 1, no. 6. [Online], Available: http://www.MedicareEd.org

Other sources utlized for this section include:

Alexander, G. A., Chu, K. C., & Ho., R. C. S. (2000). Representation of Asian Americans in clinical cancer trials. Annals of Epidemiology, 10(8), S61-S67.

Atkinson, J., & Hartmuller, V. (1994). Strategies for minority recruitment. In PCPT minority recruitment manual. Bethesda, MD: National Cancer Institute.

Brant, J. (1996). Breast cancer challenges in American Indian women. In K. H. Dow (Ed.), Contemporary issues in breast cancer (pp. 243-252). Sudbury, MA: Jones and Bartlett.

Brant, J., Fallsdown, D., & Iverson, M. (1999). The evolution of a breast health program for Plains Indian women. Oncology Nursing Forum, 26(4), 731-739.

Bunn, P., & Krebs, L. (1997). Colorado blueprint: Women and minorities in cancer care trials. Denver, CO: University of Colorado Comprehensive Cancer Center.

Center for Lesbian, Gay, Bisexual, and Transgender Health. (2000). Lesbian, gay, bisexual, and transgender health: Findings and concerns. New York: Columbia University's Joseph L. Mailman School of Public Health.

Chen, A. M. (1996). Demographic characteristics of Asian and Pacific Islander Americans: Health implications. Asian-American and Pacific Islander Journal of Health, 4, 40-49.

Chu, K. C. (1998). Cancer data for Asian Americans and Pacific Islanders. Asian-American and Pacific Islander Journal of Health, 6(2), 130-139.

Haynes, M. A., & Smedley, B. D. Committee on Cancer Research Among Minorities and the Medically Underserved. (1999). The unequal burden of cancer: An assessment of NIH research and programs for ethnic minorities and the medically underserved. Health Sciences Policy Program, Health Sciences Section, Institute of Medicine. Washington, D.C.: National Academy Press.

Hughes, C. K, Tsark, J. T., Kenui, C. K., & Alexander, G. A. (2000). Cancer research studies in Native Hawaiians and Pacific Islanders. Annals of Epidemiology, 10(8), S49-S60.

Kagawa-Singer, M., Millon-Underwood, S., Burhansstipanov, L., & Munet-Vilaro, F. (1994). Nursing research and underserved populations. In Proceedings of the Third National Conference on Cancer Nursing Research. Atlanta, GA: American Cancer Society.

Lin-Fu, J. S. (1994). Ethnocultural barriers to health care: A major problem for Asian and Pacific Islander Americans. Asian-American and Pacific Islander Journal of Health, 2, 290-298.

McCabe, M. S., Varricchio, C. G., & Padberg, R. M. (1994). Efforts to recruit the economically disadvantaged to national clinical trials. Seminars in Oncology Nursing, 10(2), 123-129.

Millon-Underwood, S. (1994). Barriers to minority participation in clinical trials. In PCPT minority recruitment manual. Bethesda, MD: National Cancer Institute.

Millon-Underwood, S., Sanders, E., & Davis, M. (1993). Determinants of participation in state-of-the-art cancer prevention, early detection/screening, and treatment trials among African-Americans. Cancer Nursing, 16(1), 24-33.

National Cancer Institute. (1997). Talking to patients and the public about cancer clinical trials: Findings from NCI's "Science Awareness Research." Bethesda, MD: Author.

National Clearinghouse for Alcohol and Drug Information. (2000). [Online], Available: http://www.health.org/ ²

Paskett, E. D., DeGraffinreid, C., Tatum, C. M., & Margitic, S. E. (1996). The recruitment of African-Americans to cancer prevention and control studies. Preventive Medicine, 25, 547-553.

Shinagawa, S. M., Kagawa-Singer, M., Chen, M., Tsark, J., Palafox, N., & Mackura, G. (1999). Cancer registries and data for "Asian Americans" and "Native Hawaiians and Pacific Islanders": What registrars need to know. Journal of Registry Management, 26(4), 128-141.

Susan G. Komen Breast Cancer Foundation. (1999). Suggestions to enhance the participation of women of color in breast cancer prevention trials. In Clinical Trial Community Outreach Efforts. Dallas, TX: Author.

The Mautner Project for Lesbians with Cancer. (2001). [Online], Available: http://www.mautnerproject.org.

Thomas, S. B., Quinn, S. C., Billingsley, A., & Caldwell, C. (1994). The characteristics of Northern Black churches with community health outreach programs. American Journal of Public Health, 84(4), 575-579.

Underwood, S. (2000). Minorities, women and clinical cancer research: The charge, promise, and challenge. Annals of Epidemiology, 10(8), S3-S12.

What You Can Do

• Use NCI resources to keep up-to-date with new clinical trial information, including www.cancer.gov

• Find local clinical trials in your community

• Attend conferences, meetings, and workshops

Why?

• To continue to learn about developments in cancer clinical trials

• To be an informed community educator

Introduction

One of the most important ways to get started in clinical trial outreach and education is to make sure you learn as much as you can about clinical trials. This section describes ways you can learn more about clinical trials.

Education and Outreach in Action

A 60-year-old insurance salesman was treated for prostate cancer 2 years ago. He recently decided that he wanted to learn more about clinical trials after he saw a TV special about them. "I'm amazed about what I don't know about what clinical trials are going on right here in (my community). I want to make sure that men who go to my support group understand information about clinical trials."

Use NCI Resources

The NCI Web site, www.cancer.gov, contains information from PDQ®, including the latest information about cancer treatment, screening, prevention, genetics, supportive care, and complementary and alternative medicine, as well as a registry of cancer clinical trials. Clinical oncology specialists review current literature from more than 70 medical journals, evaluate its relevance, and synthesize it into clear summaries, which are then reviewed monthly and updated as needed based on new information. Most cancer information summaries appear in two versions: a technical version for the health professional and a nontechnical version for patients, their families, and the public. Many of the summaries are also available in Spanish.

The NCI Web site also includes approximately 100 fact sheets on various cancer-related topics and information on ordering NCI publications, as well as educational features and news summaries concerning the latest results from cancer clinical trials.

The clinical trials registry (PDQ) contains more than 1,800 ongoing clinical trials, with information about studies around the world. All clinical trials undergo review prior to inclusion. Although no single resource lists every cancer clinical trial being conducted in the United States and abroad, PDQ is the most comprehensive cancer clinical trials registry, and contains information about trials sponsored by NCI, the pharmaceutical industry, and some international groups. Users can narrow their retrieval by multiple parameters, such as stage of disease, phase of trial, treatment modality, and geographic location. PDQ also contains an archival file of more than 11,000 clinical trials that are no longer accepting patients, including contact information for the principal investigators of trials that may not yet be published in the biomedical literature.

Accessing Information from NCI

NCI's Cancer Information Service

NCI's Cancer Information Service is a national information and education network for patients, the public, and health professionals. From regional offices covering the entire United States, Puerto Rico, and the U.S. Virgin Islands, trained staff provide the latest cancer information through a toll-free telephone service. Staff can respond to calls in either English or Spanish.

How to Reach the CIS
The toll-free number is 1-800-4-CANCER (1-800-422-6237). For deaf and hard of hearing callers with TTY equipment, the number is 1-800-332-8615. Hours of operation are Monday through Friday, 9:00 a.m. to 4:30 p.m., local time. Callers also have the option of listening to recorded information about cancer 24 hours a day, 7 days a week.

See the Guide to Finding Clinical Trial Resources for other sources of clinical trial information.

Find Local Clinical Trials in Your Community

A good way to educate yourself about clinical trials is to become familiar with both the local institutions conducting clinical trials and the clinical trials themselves. As you begin to think about ways you would like to take action, it will be important for you to understand where clinical trials are taking place.

Creating a List

You may want to create a list that identifies cancer clinical trials in your community. Collecting this information using the "Clinical Trial Community Resource Sheet" here can help you direct interested community members to the best clinical trial resources available.

This information can help you:

• Understand clinical research in your community

• Understand some of the barriers to participating in clinical trials in your community

• Provide local clinical trial resources to the organizations or individuals with whom you are working

Clinical Trial Community Resource Sheet

You may use this sheet as a reference for yourself or your organization, or you may develop it into a local fact sheet for distribution. Remember that clinical trial information becomes out of date very quickly, so you will need to update this sheet at least every 3 months. To locate information needed to complete this worksheet, you can:

• Call the National Cancer Institute's (NCI's) Cancer Information Service at 1-800-4-CANCER. Trained information specialists can search the NCI clinical trial database, PDQ, and provide contact information for local trials.

• Visit the Web site www.cancer.gov, to search the PDQ database on your own.

• Use the clinical trial resources sheet that follows for other ways to find local trials.

Type of Trial/ Type of Cancer	Phase	Protocol ID#	Institution	Point of Contact	Phone Number
filler	filler	filler	filler	filler	filler
filler	filler	filler	filler	filler	filler
filler	filler	filler	filler	filler	filler
filler	filler	filler	filler	filler	filler

Guide To Finding Clinical Trial Resources
National Cancer Institute's PDQ 3	What is it?	How do I access it?	What will it provide?
	Database produced by NCI Registry of approximately 1,800 active cancer clinical trials	Go to http://cancer.gov/clinicaltrials/ Use the search form OR Call 1-800-4-CANCER	Summaries about clinical trials conducted by NCI-sponsored researchers, the pharmaceutical industry, and some international groups
National Library of Medicine	Database produced by NIH Registry now lists 4,000 primarily NIH-supported clinical studies on many conditions, and more will be added All trials on PDQ are listed in this database	Go to www.clinicaltrials.gov Can browse by disease or sponsor or insert key words	Summaries about clinical trials for a wide range of conditions-most of the trials listed are sponsored by NIH
Local Cancer Center Web Sites	Locally produced Web sites that include listings for trials sponsored by NCI and some pharmaceutical companies Good supplementary resources for locating clinical trials; a cancer center may begin participating in an NCI-sponsored trial before the center's information is listed in PDQ	Different sites can be found through: • PDQ 3 and National Library of Medicine 4 Web sites • Local institutions Information on trials taking place at NCI's Clinical Center in Bethesda, Maryland, is available at http://ccr.nci.nih.gov Some centers may also have telephone information centers	Information that varies from center to center
Examples of Pharmaceutical Resources/Internet Clinical Trial Matching Sites	Pharmaceutical Research and Manufacturers of America (PhRMA) publishes a list of new cancer drugs in development CenterWatch's Clinical Trials Listing Service lists many industry- and Government-sponsored trials	PhRMA Go to www.phrma.org/ Click on "New Medicines in Development." The drugs are listed by cancer type or call 202-835-3400. CenterWatch Go to www.centerwatch.com Click on "Trial Listings" EmergingMed.com Go to www.emergingmed.com or call 877-601-8601	Descriptions, sites, telephone numbers and investigator names by State

Attend Conferences, Meetings, and Workshops

Some people find that attending scientific meetings keeps them up to date, helping them become better educators.

Local Meetings and Courses

Many local hospitals and cancer centers hold public events, educational workshops, and lectures on a variety of topics related to clinical trials. Contact your local institution's community relations department to find out if it holds such events and when they are scheduled.

Learning through the Internet

Many of the large cancer centers have free online courses for the public, some of which may be related to clinical trials. See the Web site www.cancer.gov for a list of NCI-designated cancer centers and their Web sites to learn more about specific online courses.

National Meetings

Scientists present the results of their research at large meetings before the results are published in the literature. Two annual meetings of importance to cancer research are:

1. American Association of Cancer Research in March of each year (Web site is www.aacr.org)

2. American Society of Clinical Oncology in May of each year (Web site is www.asco.org)

Both feature daily meeting updates on their Web sites.

Many scientific meetings are open and free to the public. Others have reduced fees for survivors or advocates.

The NCI event calendar provides a centralized and easily accessible place to obtain information about many cancer-related scientific meetings and events nationwide. The calendar can be found on the Web at www.cancer.gov. You can also call 1-800-4-CANCER to get information about these meetings.

To help you plan educating yourself, see the Plan for Action. 5

What You Can Do

• Find opportunities to talk to others-neighbors, friends, and coworkers-about clinical trials, common myths surrounding clinical trials, and where to find more information on clinical trials

• Help others understand how to evaluate research in the news

Why?

• To address the many misconceptions that exist about clinical trial treatment options

• To provide clinical trial information to individuals making treatment or prevention decisions

Introduction

As someone who knows a lot about clinical trials, you will often be given the opportunity to talk to individuals about their cancer, cancer of a loved one, or being at high risk for cancer. One of the best ways to educate other people is to talk informally about what you are learning about clinical trials.

As you seek opportunities to speak to others, keep in mind that it's important to be able to answer common questions about clinical trials. But it's also important to admit when you don't know the answers, and to seek other resources for information.

This section will guide you through some ideas to talk to others

For more information on strategies for clinical trial education, and working with ethnically diverse populations. 6

Education and Outreach in Action

A high school teacher who is a cancer survivor is finding ways to spread the word about clinical trials. Because she is active in her church, she finds herself talking to many people whose lives have been touched by cancer. She says, "People call me the cancer lady, but I don't care." She is often asked to talk to fellow church members about her experience with cancer and her treatment on a clinical trial. She says, "I used to think that clinical trials treated people like guinea pigs-a lot of folks do. I think people need to know the facts about clinical trials. No one likes to hear their own name associated with the word 'cancer.' But, how many times does someone hear about a co-worker, a friend, or a neighbor who was just diagnosed with cancer? That's how I approach other people. I tell them that it's important that cancer patients talk to their doctor about all their options. That's the best help that I can provide someone."

Get Started-Circle of Connections with Individuals

Finding Opportunities to Talk to Others

You may be active within one specific organization or have connections with many different community groups. As you think about the importance of clinical trials, think about where and how you can become a clinical trial resource to people you know. How can you help other people learn about clinical trials?

In the circles below, write down the names of at least four people with whom you feel you can discuss clinical trials. Think about these people as you work through this section.

Talk to Others-Tips

One way to provide support to others is to help those diagnosed with cancer, and those at high risk for developing cancer, to learn more about the option of participating in a clinical trial. Equally important is explaining clinical trials to those who are not facing a cancer diagnosis, but who are interested in why they are important.

Here are some tips to get you started on this conversation; keep in mind that conversations need only be a few minutes long:

1. Express empathy for the person's situation.

2. Use active listening skills.

3. Ask whether the person would like to hear some information about cancer clinical trials.

4. In your own words, talk about why clinical trials are important.

If relevant:

1. Discuss clinical trials as an option for treatment and prevention. Remember that clinical trials are not the right option for everyone.

2. Review some of the benefits and risks to participating in clinical trials.

3. Respond to common myths associated with clinical trials.

4. Explain some key ways that participants' safety is protected in clinical trials.

5. Explain some of the barriers associated with clinical trials for patients.

6. Know how to answer common questions about clinical trials. But, admit when you don't know the answers. Have resources available (such as those in this series) and the Cancer Information Service's 1-800-4-CANCER.

7. Be aware of cultural sensitivities around clinical trial issues. (See General Strategies for Educating Diverse Populations. ⁶)

8. Understand the local clinical trial resources in your community.

Help Others Understand How to Evaluate Research in the News

People often hear about the results of clinical trials from overly positive or overly negative media reports. These reports often influence the way they think about clinical trials and can help to reinforce common myths. When you find yourself talking to others about clinical trials, it will be important for you to respond to these reports in a thoughtful way. Here are some questions to consider as you help others evaluate these types of media reports.

Some of these questions will not be answered by a short article in a newspaper. You may need to locate the original research article by using PubMed or another medical library database.

Who wrote this article? Any good news article should list the author, his or her institution, and if the author is not a reporter, his or her background. Reporters are trained to be objective, but they often report on what seems newsworthy and may miss key facts. Some institutions may not list the author of an article, in which case the institution itself should be considered the author. Newspapers often use "wire reports," such as the Associated Press (AP), and often include materials excerpted directly from press releases. What is the basis of the information in the article? In addition to identifying who wrote the article you are reading, the evidence that material is based on should be provided. Medical facts and figures should have references (such as an article in a medical journal or the consensus of a meeting of experts reviewing research evidence); anecdotal evidence, opinions, or advice should be clearly set apart from information that is "evidence-based" (that is, based on research results). Does the article say if the study involved people, animals, or cells in the laboratory? In early cancer research or preclinical testing, scientists test promising new cancer treatments in the laboratory and in animal models. This is done to find out if the treatment has an anticancer effect and if it is safely tolerated in animals. Only if a new drug proves promising in the lab, does it move to testing in humans. Clearly, preclincial research only suggests future direction, and cannot be applied directly to all people with a particular type of cancer. Does the article include information on the phases of the study and number of participants? Clinical research is generally conducted in three different types of studies called phase 1, 2, and 3 studies, reflecting the order in which they take place. Each phase of a study has a different goal and, although they are often conducted separately they can be conducted as part of the same study. News articles may not mention the study phase. However, if an article refers to an "early" study, it generally refers to a phase 1 or 2 study. If an article discusses different groups of patients getting different types of treatment or different doses of a drug, or mentions that a study was "randomized," it usually means the study was a phase 3 study. Occasionally, phase 2 studies may be randomized. If the study includes a new agent or device, has it been approved by FDA? The Food and Drug Administration (FDA), an agency of the U.S. Department of Health and Human Services, must review all test results for new agents to ensure that products are safe and effective for specific uses. FDA applies two key questions to each application for drug approval: Do the results of well-controlled studies provide substantial evidence of effectiveness? Do the results show the product is safe under the conditions of use in the proposed labeling? (In this context, "safe" means that potential benefits have been determined to outweigh any risks.) Only when FDA makes the approval does it allow the drug to be "labeled" for a specific use. This label includes information on what kinds of people should be given the drug, the dosage of the drug, and information on safety and adverse effects. It is only at this time that the new drug can be given to people outside of a clinical trial. What were the characteristics of the people who participated in the study? Sometimes, studies are done only in specific groups of people-for example, people in a particular age group, or those whose cancer is at a particular stage. This may mean that the study results may not apply to those who are not members of these specific groups. Does the article discuss the benefits and risks for those participating in the study in a balanced way? Just as there are potential side effects to all medications, there are benefits and risks to all clinical trials. The article should fully describe the known benefits and risks, as well as note that there may be side effects or risks that are unknown. If the article appears to be one-sided or overtly positive, you may be justified in having some skepticism about the author's motives. Who funded the study? Studies can be funded from many sources. The most common sources in the United States are the Federal Government, universities, private foundations, or industry (such as pharmaceutical companies or companies making a device that is being tested). If a researcher has received funding from a source, such as the Federal Government, that uses a peer review process for evaluating and awarding research funds, the research findings will be more credible and less subject to bias than if the sponsor has a vested interest in the results. Who conducted the study? It is important that research studies have scientific review and ongoing oversight. Studies that have been through this level of scrutiny are more likely to produce high quality results than those that have not been reviewed. Were the study results "peer reviewed" or just announced at a meeting or through a press release? If the news article was based on a published article in a peer-reviewed journal, it means that other experts have examined and critiqued the researchers' methods and findings.

What You Can Do

• Find opportunities and develop a strategy to speak about clinical trials and/or:

  • Present NCI Clinical Trials Education Series slide programs or the awareness video "Cancer Trials…Because Lives Depend on It"

  • Distribute educational booklets and brochures from the Clinical Trials Education Series: ¹

    • At meetings or events

    • Through doctors' offices

    • Through a booth at health fairs or events for local research institution(s)

• Write articles for newsletters; post articles on Web sites

• Host an information session or community forum on clinical trials

• Form a clinical trial advocacy coalition

Why?

• To provide information to people about cancer clinical trials before they are faced with a cancer diagnosis

• To provide information about a specific cancer trial to members of your community

• To provide people with the tools they need to find out about trials in your community

• To educate interested members of the public about the importance of cancer clinical trials

• To help debunk myths about clinical trials in the community

• To develop a community strategy for clinical trial outreach

Introduction

This section provides ideas for educating your community about clinical trials. Whether you use personal contacts, community organizations, or health-related organizations, remember that combining strategies to get clinical trial messages out to your community will make your outreach more successful. Using different ways to get out critical messages about clinical trials increases the chance that people in your community will absorb and remember them.

See the NCI Trainer's Guide for Cancer Education 8 for ways to teach others about these issues. Information about ordering can be found at the front of this guide.

Education and Outreach in Action

A chapter of a local cancer advocacy organization had been trained about clinical trials. Several members organized a community forum, inviting the local researchers on a breast cancer prevention trial to speak. They also invited several women who considered participating in the trial. More than 75 people attended the forum at the local YMCA.

A local cancer support group has a Web site and a quarterly newsletter. The group's education committee copied the articles included here and put them on its Web site and in its newsletter. At the next meeting, the group decided that all of its members should learn about clinical trials.

Get Started-Circle of Connections with Groups

Everyone has connections with different groups in his or her community. Some people represent a specific organization. Others may have connections with many different community groups.

As you think about the importance of clinical trials, think about where and how you can become a clinical trial resource to these groups. How can you help engage the organization in this issue?

In the circles below, write down at least five groups or organizations you feel you can educate. The groups don't need to be cancer-related, but should have a health focus. Keep these groups in mind as you complete this section.

Expand Your Organization's "Community"

It is important to think broadly about other organizations with which you can partner, whether you are part of a group or organization that already has a clinical trial agenda, or if you want your group to develop one.

A given geographical area includes many "communities." In the following table, write down the organizations you identified on the previous page.

Then, think about:

• Reaching out to other groups in your community who are likely to share clinical trial priorities

• Partnering with organizations with which you haven't yet worked

• Contacting people who can put you in touch with key leaders of these groups

The pages that follow will help you prioritize your outreach efforts. It will be important to consider balancing your efforts between groups that are easy to reach with others that will take more effort.

More information on working with different ethnic/minority groups. 6

Organization Contact Worksheet

Organization Type	Examples in My Community	Contact People in Community
Advocacy organizations	filler	filler
African American,