1. Study Accrual… Recruiting Across the Spectrum ACRIN – RA Education Session September 29, 2010 Pentagon City, VA Lorna Beccaria, RN, BSN, CCRC

2. Three Distinct Tracks Working with Health Care Professionals Working with Community Members, Advocates and Underrepresented Populations Working with Patients in a Clinical Setting

3. Goals Enhance clinical trial accrual through outreach and education efforts at local institutions and in the community Increase clinical trial accrual/participation in underrepresented populations (women, minorities, rural communities, older patients with co- morbidities) Identify strategies for increasing patient accrual i.e. use of multimedia resources

4. Objectives Learning Objectives: Identify strategies to address barriers to clinical trial participation Assess the needs of specific groups: health care professionals, community members, advocates & patients Incorporate key factors to tailor educational approaches for specific groups

5. Working with Health Care Professionals

6. Barriers to Participation in Clinical Trials Lack of awareness of appropriate clinical trials Unwillingness to “lose control” of a patient’s care Belief that standard therapy is best Belief that referring and/or participating adds administrative burden and cost Unsure how to address patient concerns or physician expertise about clinical trial participation Little connection between community cancer care and conduct of clinical research

7. Key Messages Educate Health Care Professionals: –Clinical trial design –How clinical trials work & advance care –Patient protection (IRB, consents, advocates) –How to respond to patient concerns –Ways to participate in clinical trials –Keep patient/physician engaged and involved –Accessing clinical trials resources

8. How to Reach Health Care Professionals Multimedia Resources (i.e. CTES slide show): –Talks in physician offices, nurse educators, hospitals, tumor boards –Talks at local and state medical societies –Talks at professional meetings Letters, fax, email to solicit referrals Exhibits at conferences Local and national press coverage

9. Working with Community Members, Advocates & Underrepresented Populations

10. Working with Community Members and Advocates Provide “key” descriptions: define clinical trials, describe type/phase of trial, purpose and significance Explain how clinical trials advance care Discuss and respond to barriers and myths Describe how patients are protected: informed consent, IRB’s, FDA, advocates Community and web based resources Role of patient advocates in the research process

11. Underrepresented Populations Rural communities Elderly patients, especially those with co- morbidities Pediatric patients Women Minorities Patients with low literacy skills

12. Barriers for Underrepresented Populations Language and literacy issues Difficulty with transportation, child care, time off from work Cultural beliefs Lack of health insurance and general health care Concern about past abuses Distrust of “Western” medicine

13. Present clinical trials in a respectful, honest, easy-to-understand manner Address risks and benefits openly Stress importance of equal access to high quality health care, including clinical trials Be sure the informed consent process reflects participant’s understanding How to Address Barriers

14. How to Address Barriers (cont.) Understand concerns of particular ethnic/cultural groups Provide evening/weekend appointments Provide transportation, meal vouchers Explain how subjects’ rights are protected (don’t deny past abuses) Have educational materials in patient’s native language at his/her literacy level

15. Working with Patients in the Clinical Setting

16. General Barriers to Participation in Clinical Trials General Attitudes Toward Research Protocol Related Issues Logistical Concerns Influence of Others Decision Process/Other Issues Social Barriers

17. General Attitudes Toward Research Unwilling to go against physician’s advice Dislike of being “experimented on” Mistrust of research Lack of education about clinical trials Perception that care will not be as good

18. Protocol Related Issues Dislike of randomization/possibility of the “placebo” Potential unknown side effects Trial treatments offer little or no personal benefits

19. Logistical Concerns Increased personal cost Diminished or lack of health insurance coverage Inconvenience to everyday life, time impact, travel costs

20. Influence of Others Opinion of spouse, SO, family, friends or other support system Degree of the family support system Perceived strength or weakness of physician’s recommendation CRA’s recommendation or influence

21. Decision Process/Other Issues Fear of losing control over decision making process Feeling of being coerced to join Stress of diagnosis, especially if terminal Religious/spiritual beliefs Altruistic Motives

22. Social Barriers to Clinical Trials Low Income Participants, even when they have health insurance: –have more difficulty gaining access to care –face challenging circumstances such as: disconnected telephones, transportation issues multiple or inflexible jobs unaffordable copayments for medication often have cultural and language barriers

23. Social Barriers (continued) –For low-income patients who obtain care: treatment plans may also be complicated by competing priorities. many make tradeoffs between health care and other basic needs, such as housing, food, and utilities.

24. Use of Multimedia Resources in the Clinical Setting Patient oriented slide programs, videos, booklets and other publications (i.e. CTES) Social marketing Disease-based help lines –LiveHelp: from the NCI, offers live phone, online & chat options –Need Answers?: from the ACS, offers 24/7 live phone support

25. CTES (Clinical Trials Education Series) Components Publications Booklets DVD’s Slide Programs (CD-ROM) also in Spanish Online Training & Education Courses Order from 1-800-4-CANCER (1-800-422-6237) or download at www.cancer.gov/publications

26. Web Based Public Information/Recruitment (continued) AccrualNet.cancer.gov –Resource/professional community for clinical trial accrual ResearchMatch.org –Registry for research volunteers and researchers Cancer.org –American Cancer Society ClinicalTrials.gov –Searchable database for patients, family & public

27. Coordinator Tactics!!! In the context of a Breast MRI Clinical Trial Pre-screen –Clear and complete explanation of requirements of the procedures, provide informed consent etc MRI “trial run” Use of anti-anxiety agents Schedule of events, copies of all reports Timely follow-up with patient and MD’s

28. Conclusion THE KEY IS EDUCATION… And the RA is the Key Educator!