Recruiting African American Men to a Cancer Prevention Trial

1. Recruiting African American Men to a Cancer Prevention Trial Elise D. Cook, M.D. Chair, Minority and Medically Underserved Subcommittee, SELECT Chair, Sites at Risk Review Committee, SELECT June 15, 2009 Houston, TX

2. SELECT Roles • Principal Investigator • M. D. Anderson Cancer Center Site • Chair • SELECT Minority and Medically Underserved Subcommittee • Sites at Risk Review Committee • Co-Chair • SELECT Retention and Adherence Committee (RAC) • Chair, RAC Publications Working Group • Chair, RAC Planning Working Group • Participant’s Spouse

4. Primary Objective Assess the effects of selenium and vitamin E alone and in combination on the clinical incidence of prostate cancer

5. SELECT Trial Design • Double blind • Placebo controlled • 2 x 2 factorial • 32,400 men • 5 year accrual SELECT SELECT SELECT SELECT

6. Minorities Census effects on classification of race and ethnicity 2000 Census Race Categories • White, black, Native American, Asian, Asian Pacific Islander, some other race (select one or more) 2000 Census Ethnicity • Hispanic or Latino identity is considered ethnicity • Latinos may be any race

7. Why include Underrepresented Subgroups? Valid, generalizable data requires the inclusion of subgroups proportionate to the general population.

8. SELECT Minority Recruitment Goals • African American – 20% • Racial group most affected by CaP • Hispanic – 3% • Asian American – 1%

10. SELECT Accrual • Activated July 25, 2001 • Accrual closed June 24, 2004 • National accrual goal of 32,400 men was reached 28 months earlier than projected!!

11. Planning Phase Recruitment Phase Follow-up Phase 7 to 12 years is a long time!!! SELECT Challenges and Lessons Learned

12. SELECT Pre-recruitment Phase • Eligibility Criteria changes • Performance Status change from 0 to 1 • Eligibility age for African American men decreased to from 55 to 50 - reflects equivalent risk of prostate cancer

13. SELECT Recruitment Phase • Overall recruitment occurred rapidly • African American recruitment goal = 20% • Unable to make this goal with such rapid recruitment • Strategies were implemented to achieve African American recruitment at 15%

14. National Participant Advisory Board Appointed July 2003

15. Barriers to Recruitment • Study Design (Inclusion/Exclusion Criteria) • Physician impact (knowledge, attitude, time) • Economic issues (cost to participate) • Personal / Cultural influences (historical treatment by healthcare system)

16. Prevention Trial Recruitment Issues • Healthy individuals • Sometimes unaware of the disease or organ being studied example: prostate cancer, ovarian cancer • Fewer clinic visits available to “tag-on” research • (increases study costs) • Long follow-up period (more expensive) • (adherence and retention are important issues) • More expansive recruitment strategies

17. Recruitment Process 1. Identify internal and external resources 2. Set recruitment goals 3. Develop strategies 4. (Re)-prioritize strategies 5. Implement strategies 6. Evaluate strategy 8 Monitor accrual, adherence and retention 7. Retain, revise or remove strategies

18. Minority Recruitment Barriers • Language • Other cultural communication issues • Attitudes and beliefs • Access to health care • Current health status • Socio-demographic factors

19. Recruitment in Special Populations • Cultural competence is key • Develop a long-term relationship with the community • Translated materials • Low literacy • Eliminate costs associated with the clinical trial if possible

20. African American Recruitment • Trust and respect are huge issues with African American subjects • Tuskegee Syphilis Study • Prior negative experiences in the U.S. health care system

21. Tuskegee Syphilis Study • 1932 to 1972 by the USPHS • Document the natural history of syphilis • African American researchers also involved • Subjects told they had “bad blood” – deception • Cover up involved preventing military service

22. Tuskegee Syphilis Study Benefits • free meals • free medical examinations • Burial Insurance

23. SELECT and Tuskegee SELECT Workbench: Staff training tool – Fact Sheet “Background Information on the Tuskegee Syphilis Study” SELECT Workshop: Presentation - Tuskegee Syphilis Study

24. Minority Recruitment to SELECT • Pre-activation Recruitment Strategies • Study Activation Recruitment Strategies • Post-activation Recruitment Strategies • Results

25. SELECT Pre-activation Recruitment Strategies • FOCUS GROUPS • ELIGIBILITY CRITERION • SITE INCLUSION • INFRASTRUCTURE • SELECT WORKBENCH • SELECT WORKSHOP

26. FOCUS GROUPS • Input from men in the target population • 78 men participated with 16 African American and 32 from the VA system • Recommendations regarding communications • Highlight personal incentives • Explain why the study supplements were chosen • Provide frequent study updates • Include family members especially spouses • Special strategies for recruitment of minority, low literacy, low income and medically underserved men

27. Eligibility Criteria Changes • Performance Status change from 0 to 1 • More co-morbid conditions are prevalent in minorities • Minimal age lowered to 50 for African Americans • Risk of CaP for African American men at age 50 ≥ risk for men of any other race at 55

28. Site Inclusion • Extra consideration to sites with access to large minority populations • Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) • Women’s Health Initiative (WHI) sites • VA sites • Minority-Based Community Clinical Oncology Program (MB-CCOP) sites

29. SELECT Pre-activation Recruitment Strategies • INFRASTRUCTURE – MMUS of the RAC, a full-time SELECT MMUS recruitment and adherence coordinator • WORKBENCH – password protected Website with study and recruitment materials • SELECT WORKSHOP - semi-annually with funding for one representative per site to attend

30. INFRASTRUCTURE • Recruitment and Adherence Committee and later the Retention and Adherence Committee (RAC) • Minority and Medically Underserved Subcommittee (MMUS) • Diverse expertise (NBLIC II, CDCP, NCI, NMA, VA, SWOG Statistical Center and Operations Office) • Recruitment and Adherence Coordinators

31. SELECT WORKBENCH • Password-protected web site • Intended for study site use • SELECT study materials, documents and reports • Monthly, overall and African American accrual reports listed by site • MMUS and RAC performed regular evaluations of recruitment

32. SWOG/SELECT WORKSHOP • Funding provided for 1 representative per site to attend a 1 ½ day workshop • Coincides with the semi-annual SWOG meetings (Cost effective)

33. SWOG/SELECT WORKSHOP • Each workshop includes • Session for new staff • General session to provide SELECT status updates • Protocol or procedural changes • Discuss relevant research • ½ day poster session • Sites display recruitment and adherence materials and programs • Features partner organizations • Key elements of SELECT

34. SELECT Study Activation Recruitment Strategies • National press release • About 13% African American response • Many local SELECT releases

35. SELECTPost-activation Recruitment Strategies • Minority Recruitment Enhancement Grants • Minority Recruitment Workshops • Partnership with NBLIC II • SELECT Sunday • National media personalities

36. Minority Recruitment Enhancement Grants • Competitive review process • Recruit substantial number of minorities • 15 sites awarded grants (1 or 2 years) • Monthly reports – • Recruitment strategies implemented • Simple success rating per strategy • MREGs supported additional recruitment and adherence materials and site staff

37. Minority Recruitment Workshops • Three 1-day workshops • Round table discussions • Sharing strategies, develop mentoring relationships and discuss problems • Panel discussions with local community leaders and SELECT Investigators • Shared recruitment ideas • Disseminated workshop proceedings to all SELECT staff at the semi-annual SWOG/SELECT Workshops

38. Partnership with NBLIC II • Minority outreach initiative of the NCI • Innovative outreach strategies partnering with the local SELECT sites • For Men Only retreats, Wellness on Wheels, and Taking it to the Top, • Promotional items for events • T-shirts, squeeze water bottles and caps with the SELECT logo

39. SELECT Sunday • Faith based, prostate education and SELECT recruitment initiative • Churches and Mosques in large cities • Pastors delivered the information from the pulpit • Prostate cancer and SELECT enrollment information was distributed to members

40. National media personalities • Les Brown - Television and radio personality, author and motivational speaker • Radio media tours, inroads to national programs, information on his website • Ian Smith, MD – former medical correspondent for NBC news network • NBC Nightly News program on the importance of enrollment of minorities to clinical trials featuring a SELECT participant – September 2002

41. Dr. Ike Powell and Mr. Les BrownPromote SELECT on a Radio Tour

42. SELECT Final Accrual • National accrual goal of 32,400 was reached 28 months earlier than projected!! • Final accrual was 35,534 • National accrual goal for African American men was 20%, actual was 15% • National accrual goals for Hispanic, and Asian / Pacific Islander were 3% and 1%, actual were 6% and 1%

44. Minority Recruitment to SELECT Elise D. Cook, MD Associate Professor, Dept. of Clinical Cancer Prevention UT M. D. Anderson Cancer Center