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Study Accrual… Recruiting Across the Spectrum

Study Accrual… Recruiting Across the Spectrum. ACRIN – RA Education Session September 29, 2010 Pentagon City, VA Lorna Beccaria, RN, BSN, CCRC. Three Distinct Tracks. Working with Health Care Professionals Working with Community Members, Advocates and Underrepresented Populations

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Study Accrual… Recruiting Across the Spectrum

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  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. How to Address Barriers • 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

  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!

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