1. Strategies for Cancer Clinical Trials Education and Awareness: Lessons from the Field

2. Why should we care? Cancer affects all of us Each year in the U.S.A: − More than half a million people die of cancer — more than 1,500 people a day − People of color are disproportionately affected by cancer

3. Cancer Disparities Defined NCI defines "cancer health disparities" as “... adverse differences in cancer incidence (new cases), cancer prevalence (all existing cases), cancer death (mortality), cancer survivorship, and burden of cancer or related health conditions that exist among specific population groups in the United States.”

4. Who participates in cancer clinical trials? Less than 5% of all eligible people with cancer Few over age 65 Ethnically diverse populations − Even fewer in many large prevention trials

5. Inclusion of women and minorities 1986 inclusion of women encouraged 1987 inclusion of minorities encouraged 1993 NIH Revitalization Act 1994 NIH revised inclusion policy to mandate that women & minorities MUST be included in all clinical research studies

6. “Widespread access to clinical trials and racial and ethnic proportionality is less a matter of scientific necessity than of social justice” - Brawley, 2004.

8. Barriers To Clinical Trial Participation

9. General Barriers to Participation in Clinical Trials Many do not know what a CT is Fear of research – historical abuses Fear treatment will be withheld Lack of access to CTs Personal and practical obstacles (language) Cost and insurance concerns (out of pocket costs) Cultural influences Unwilling to go against doctor Study design eligibility criteria (i.e. co-morbidities) Low health literacy

10. Healthcare Provider Barriers Unaware of clinical trials Unwillingness to “lose control” of patient’s care Belief that standard therapy is the best Administrative burden Not enough time to discuss option with patients Judge that patient would not be interested

11. Role of Physician in Clinical Trials Participation Source: A Quantitative Survey of Public Attitudes Toward Cancer Clinical Trials R.L. Comis, C.R. Aldige, E.L. Stovall, L.U. Krebs, P.J. Risher, H.J. Taylor (2000)

12. How Do People Find Out About Clinical Trials? Their physicians –Inform them clinical trials are an option they might look into –Refer them to specific clinical trials –Conduct trials as part of their own practices They hear about them from trusted sources – family, friends, community leaders, etc. They search out options on their own.

13. Barriers for Ethnically Diverse Populations Fear and skepticism due to past abuses Lack of invitation/awareness Cultural barriers Language/Literacy

14. A Tale Of Two Approaches Promoting clinical trials broadly among populations that have cancer disparities. Promoting specific clinical trials that address high priority cancer needs expressed by populations/communities with cancer disparities. What are the pros and cons of each of these?

15. Minnesota Cancer Clinical Trials Education and Awareness Network (MCCTEAN) 2002 - 2005

16. MCCTEAN A statewide network with a goal of creating awareness about cancer clinical trials and providing educational opportunities for health professionals, the public and individuals/families with a cancer diagnosis.

17. Recruitment of patients to trials Recruitment of healthy subjects to studies Physicians Allied health workers Community leaders Public EDUCATION

20. 4 Leaders – 2 Approaches Focus on health professional education –Training on NCI’s CTES materials –Assessment –Integration of the topic at cancer/health conferences –Community clinic trainings (FQHC) Focus on community education –Tour of research labs, cancer centers, etc. –Integration of clinical trials at community events and health fairs –1:1 navigation; education classes; DVD Ongoing activities at home institution and with regional partners

28. Over 20 resources Brochures, Workbooks, Web site, Slide shows, Videos, DVD, CD, and Booklets Created as a train-the-trainer program Targeted education and outreach to health professionals and the community

29. Importance of Community Outreach Informing your community about clinical trials can… – Overcome barriers to enrollment in trials – Help people make informed decisions about cancer treatment and prevention options – Make community aware of the option of participation in a clinical trial

30. Considerations for Community Outreach Be familiar with communities you are serving: – Decision making – Gate Keepers/Leaders – Informed Decision making is the message not recruitment Address potential risks of trials, in addition to benefits: – Involve those who help with decision making – Provide ample opportunities for questions – If you sense hesitation, address it head on; use this as an opportunity to for dialogue – Stress patient rights to withdrawal – at any time Avoid conducting outreach that will disrupt work and home schedules. Stress importance of equal access to highest quality care –Incorporate clinical trials information in all cancer-related programs – Highlight the advances made clinically

31. Considerations for Community Outreach Present clinical trials information in a way that – complements the audience’s values – is respectful and easy to understand – uses multiple approaches: publications, videos ― Testimonials, stories ― Small group discussions – addresses fears and concerns Organize tours for community leaders and doctors Develop a mechanism for visits by patients Present clinical trials information in an unbiased way

32. Barriers for Specific Populations

33. Asian Americans Different Values –Decisions by consensus –Group welfare –Family centrality “Saving face” Degree of acculturation Language barriers

34. Native Americans Past discrimination Tribal “taboo” -loss of body parts Different communication styles Traditional gender roles Language barriers Other co-morbidities

35. Latinos/Hispanics Fatalism Use of folk remedies Delays seeking health care Fear History of past abuses Family/Work responsibilities Poor MD/pt communication Language barriers (regional dialects)

36. African Americans Lack of awareness History of past experiences Experiences with medical systems Fear Hopelessness, fatalism Lower priority Family and/or work responsibilities Researchers not giving back to community

37. What’s Wrong? A cancer center has been working to build a relationship with the local Indian tribal community. At a recent meeting with Tribal council leadership, a nurse talks about a new clinical trial and hands out information detailing how patients are randomized to arms of the trial. She says, ‘If any of your members are diagnosed with lung cancer, feel free to pass this out…”

38. What’s Wrong? A medical center puts an ad in the paper for a breast cancer prevention trial. The team makes sure to include ‘Se habla espanol’ in the ad. When staff get a call from a Spanish speaker, no one can find the Spanish speaking nurse to help the caller.

39. Other MCCTEAN Activities

40. Cancer Clinical Trials Conference To inspire communities of color, policy makers and providers to establish and strengthen partnerships and collaborative relationships to reduce cancer health disparities while understanding the barriers that prevent the benefits of research from reaching all populations in Minnesota.

41. Promote participation in prostate cancer screening and prevention trials. Provide all cancer patients with information about clinical trials. Conduct outreach programs in racial and ethnic minority communities that communicate the results of clinical trials, as well as the benefits of clinical trials to individuals and to communities. Expand the clinical trial infrastructure into racial and ethnic minority communities, including employment of culturally diverse staff. Use community lay health educators to increase awareness of clinical trials in community settings. Solicit participation from racial and ethnic minority communities on Institutional Review Boards (IRB). Cancer Plan Minnesota 2005-2010

42. Strategies - Institutional Have community members be part of the IRB Clinical Research Advisory with community members Tours of facilities for community gatekeepers Three “R” (Recruitment, Retention, Reporting back) –Recruitment should not be the sole focus –Studies should take into account or include co-morbidities –Retention plan – learn about the experience, why they stay and why they withdrawal –Report back – send period letters to participants, referring physicians and final report to community gatekeepers and community papers Reduce literacy levels of informed consents System to identify and match newly diagnosed patients with available clinical trials –Clinical Trials navigator/coordinator

43. Final Lessons Learned For sustainability – have $$ and dedicate a staff person to the project Keep in mind everyone is busy Measure knowledge/awareness, not recruitment Cast a wide net of partners Talk ahead of time with key contacts to determine appropriate content and speakers

44. Resources Clinical Trials Education for Native Americans – http://natamcancer.org/page147.html http://natamcancer.org/page147.html Education Network to Advance Cancer Clinical Trials (ENACCT) – http://www.enacct.org/http://www.enacct.org/ Eliminating Disparities in Clinical Trials (EDICT) – http://www.bcm.edu/edict/home.html http://www.bcm.edu/edict/home.html NCI’s Clinical Trials Homepage – http://www.cancer.gov/clinicaltrials http://www.cancer.gov/clinicaltrials

45. Questions?