1. Minority Clinical Trial Participant Webinar: Difficult Conversations Daniel E. Epner, M.D. General Oncology Department Medical Director, International Center MD Anderson Cancer Center September 15, 2010

2. Outline for Today’s Webinar  Background: barriers to minority participation in clinical trials (~10 min)  Focus on the conversation  Conceptual framework (~10-15 min) Patient centered communication Motivational interviewing  Simulation

3. Barriers to Minority Patient Clinical Trial Participation  Awareness  Opportunity  Acceptance Ford et al. Cancer 2008;112:228–42.

4. Barriers to Clinical Trial Accrual Relating to Awareness  lack of education  lack of culturally appropriate information (language barriers)  Lack of cancer knowledge  Lack of physician awareness of trials Ford et al. Cancer 2008;112:228–42.

5. Barriers to Opportunity to Participate in Clinical Trials  older age  socioeconomic status  inadequate health insurance  Co-morbid conditions  lack of provider referral  patient/provider communication or provider’s method of presenting information about the trial to patient

6. Barriers to Acceptance of Enrollment  Mistrust of research and medical system  Cost, transportation, time  Fear

7. Barriers CANCER January 15, 2008 / Volume 112 / Number 2

8. Physician Perspectives on Barriers to Minority Recruitment  Barriers perceived by Physician  Structural barriers  Patient related barriers Hudson et al, Cancer Control November 2005

9. Barriers to Minority Recruitment Perceived by Physician  Lack of awareness or information about trials  Insufficient resources –too much paperwork  Lack of proven therapy with reasonable results available  Protocols are too complex Hudson et al, Cancer Control November 2005

10. Structural Barriers to Minority Recruitment  Lack of staff to support referring patients  Paperwork involved with referring patients  Lack knowledge about available CCTs Hudson et al, Cancer Control November 2005

11. Patient Related Barriers to Minority Recruitment Perceived by Physicians  patient concern about receiving ineffective treatment: 45% of oncologists  patient concern about being treated like a “guinea pig”: 59% of oncologists Hudson et al, Cancer Control November 2005

12. Mistrust as a Barrier to participation in clinical trials  Tuskegee experiments  “guinea pigs”  Power imbalance  sensational media reports of bad outcomes  Fear of randomization to placebo group

13. “I am not your guinea pig.”  “I have had a patient tell me more than once I am not your guinea pig. I try to get in enough time with the patient before they shut down and explain that this is not being someone’s guinea pig but that this maybe what we use next as standard of care.”

14. Lack of health literacy  “It can be overcome by taking the time to teach the patient and their family/support about the patient's condition and the importance to be in compliance with treatment & research protocol.”

15. Patient Centered Communication  Understand patient’s perspective  Respond to emotions: patient’s and yours  Help patient make the best choice on his own behalf. Explore concerns, priorities, and goals Give patient the information he needs. Confidently recommend a plan Patient Centered Communication in Cancer Care, Epstein and Street, NCI monograph 2007

16. Understand Patient’s Perspective  Ask before telling  “what is your understanding of your illness?”  2 minute rule  80/20 rule  “Frisbee”  “what worries you most?”  “Tell me more.”

17. Responding to emotions with empathy  “I know this must be very difficult for you.”  “I can’t imagine how difficult this must be for you.”  “You have been very brave through this entire ordeal.”  “I wish….”  Allow for space (silence) in the conversation  Avoid premature reassurance: “Everything will be just fine.” “Don’t worry, we will take care of everything”

18. Motivational interviewing  Help the patient make the best choice  Focus on patient concerns, needs  Negotiate rather than persuade  Speak to patient as equal  Encourage patient to participate in decision  Collaborate rather than convince