Project CHURCH: African American Participation in a Clinical Trial

1. Lorna H. McNeill, PhD, MPH Assistant Professor, Department of Health Disparities Research University of Texas M.D. Anderson Cancer Center Project CHURCH: African American Participation in a Clinical Trial

2. Objective • Cancer-related health disparities • Project CHURCH aims and study design • Lessons learned

3. Introduction • Cancer-related health disparities • Cancer is the 2nd leading cause of death for racial/ethnic minorities in Texas. • One-third of all cancer deaths are attributed to lifestyle factors such as diet, overweight and obesity, and physical inactivity, and thus can also be prevented. • Regular screenings to detect breast, cervical, prostate, and colorectal cancer can catch cancer early and reduce death.

4. Introduction • African Americans in Texas are making progress in some areas (reduction in heavy drinking) • In recent years, cigarette smoking, physical inactivity, and overweight and obesity are increasing among African Americans in Texas and fruit and vegetable consumption is declining. • Cancer screening for colorectal cancer has remained stable; mammograms by African American women over 40 has declined

5. Department of Health Disparities Research • Philanthropy funding • Develop common research study that would benefit junior faculty • All faculty are Co-Is • Provide service to the community

6. Why the church? • Black churches have promoted health, education, business, and political activism within the African American community. • In general, African American churches include health services and programs to their membership. • They have been an effective partner for health promotion efforts, including cancer, diet and physical activity research. • 70% of African American regularly attend church. • Families have been members for generations; increases our ability to locate participants in later years.

7. Why the church? • Windsor Village United Methodist Church • One of the largest UMCs and in Houston; ~ 15, 0oo members • Active church with over 100 ministries, engaged in health & social-related services • Engaged pastor and congregation • Long-term relationship with M.D. Anderson

8. Project CHURCH: Objective • Creating a Higher Understanding of Cancer Research and Community Health • Research study: investigate the role of behavioral, social, and environmental factors on minority health and cancer-related disparities among African Americans • Long term goal: use this knowledge to help African Americans in the Houston area reduce their risk for cancer and improve quality of life

9. Project CHURCH: Study Design • Prospective, longitudinal cohort study • Investigate the role of behavioral, social, and environmental factors on minority health and health disparities in cancer. • N= 1501 church members • Follow them for 2 years; 3 data collection points: • Baseline • 12 months • 24 months

10. Project CHURCH (Baseline)

11. Who can participate • Goal was to include as many persons as possible • Eligible: • Be age 18 and above • Must live in Houston area • Must have a working telephone number • Must attend church

12. Individual and church benefits • Individual compensation ($30 Visa debit card) • Health information, including mailed newsletters (4 per year) • $4000 annually to church • Limited patient navigation services • Church activities • Future benefits – grant dollars, additional collaborators

14. Project CHURCH: Study Aims • Aim 1: Develop and organize a research collaboration with Windsor Village United Methodist Church to implement the African American Cancer Prevention Project; • Aim 2: Recruit and survey ~1501 church members to identify factors associated with cancer health disparities in African Americans and follow them for an additional 2 years; • Aim 3: Share research findings with the church community; • Aim 4: Provide referrals to the church community for health-related services; • Aim 5: Develop and evaluate interventions to improve cancer prevention among African Americans in Houston.

15. Aim 1: Develop a research collaboration (2 years) • Pastor Kirbyjon H. Caldwell • M.D. Anderson Board of Visitors • At least 4 meetings over 2 years – developing trust • Questions: • How does this benefit the church body • Why was Windsor Village selected • Will the congregation get care at M.D. Anderson

16. Aim 1: Develop a research collaboration • Community Advisory board • M.D. Anderson Department of Health Disparities Research faculty, church leaders, and church members. • Discussed study design • Assisted with recruitment procedures • Assisted with developed the questionnaire • Assisted with retention of participants • Met at least 6 times over the 1st year • The advisory board identified challenges and barriers to implementing the study appropriately. • Engaged and meaningful participation; used CBPR principles • Goal to increase the relevance of the study to their members

17. Aim 2: Recruitment • Project CHURCH Kick-Off • Pastor Caldwell introduced me to congregation and allowed me to speak • Health fair – recruited 500 participants in 1 day • Study telephone number and email account • Video announcements during church services • Ushers handed out recruitment postcards • Icon and recruitment information included on church website

18. Aim 2: Recruitment • Setting • We have paid/donated office space located at the church; participants complete the survey in this office • Anchors us to the church and the community

19. Aim 3: Share findings • Shared preliminary findings with Pastor Caldwell and Advisory board • Creating a booklet to share with participants and congregation • Decided not to share data publicly until church had data first

20. Aim 4: Provide services and referrals • We provide patient navigation services to Project CHURCH participants and the entire church • This year we are working with their cancer ministry to identify persons in need; we are also implementing an evaluation of our navigation services

21. Activities

22. Aim 5: New interventions • Work with church to develop interventions based on survey findings and/or bring other resources based on need

23. Leveraging Project CHURCH Internal Philanthropy $875,000 Houston Endowment $1M NIH (R21) $434,500 African American Cancer Prevention Program Grant with a Yellow Border is Pending

24. Why did people participate? • Anecdotal; many reasons • Cancer family history • Service to God and mankind- doing something that will benefit others • Most did not even know they would be compensated • Many thought they had to give blood and still wanted to participate • Survey allowed us to work on building relationship first; now we can ask for more invasive tasks/procedures, i.e., DNA • Great customer service • Survey quick and easy

25. Project CHURCH (Year 2 & 3) • Collect DNA - Saliva • 95% participation rate • Accelerometer data (physical activity) • N=500 agreed to participate • Additional data • Financial strain • Living will • Rotating data

26. Is Project CHURCH successful? • Getting there... • Met accrual goals early – 6 months vs. 12 months • 95% retention rate: Goal 70% • Received additional funding • Ongoing process… • Sharing findings with congregation • Long-term relationship • Lots of trust, but still need to prove oneself

27. Retention of participants • Retention is closely linked to satisfaction • Begins with recruitment materials (non coercive), consent signing (need to understand the study and what is expected) • Treating participants with respect • Great customer service • Communication between research staff • Respond to complaints quickly • Attention to factors such as transportation etc. Source: Cheryl Oncken, M.D., MPH

28. Methods to Enhance Retention • Communication with staff • Offer convenient physical access and appointment times • Newsletters • Provide written or telephone contacts between visits • Project CHURCH participants received notices about program activities first • Financial compensation • Above all—make it relevant!!! Source: Retention of asthmatic patients in a longitudinal clinical trial

29. Lessons Learned • Study population and setting should be appropriate for the research question being asked • Recruitment methods can be very effective; need to be prepared for response • Individual financial compensation is not enough of a benefit – need to make a connection to a value • Long-term commitment

30. Acknowlegements • Windsor Village pastor, congregation, advisory board • Project CHURCH staff • Health Disparities research faculty