CLINICAL TRIALS TRAINING PROGRAMS for COMMUNITY LEADERS, HEALTH CARE PROVIDERS and CLINICAL TRIAL TEAMS
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- Bernadette Simon
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1 CLINICAL TRIALS TRAINING PROGRAMS for COMMUNITY LEADERS, HEALTH CARE PROVIDERS and CLINICAL TRIAL TEAMS Background Although all major advances in cancer survivorship and quality of life result from successful cancer clinical trials research, trial participation among adult cancer patients remains at about three percent. 1 This rate is even lower among people of color and the medically underserved, 2 who tend to have higher cancer mortality rates than the population as a whole. There are a number of structural, cultural, and linguistic barriers that negatively affect participation in clinical cancer research; many are clearly related to lack of knowledge and to underlying attitudes and beliefs on the part of patients as well as their health care providers. In our efforts to reduce these barriers, we must seek innovative ways to not only enhance the knowledge, attitude and skills of community members, but those of community health care providers and clinical trial investigators themselves. ENACCT has developed five innovative educational programs for community leaders, primary health care providers and clinical trial investigators. Since we have piloted these programs in with promising results, we are now offering these programs nationwide. ENACCT has developed five mutually reinforcing educational programs, as summarized in the table below and described on the pages that follow. The program includes five critical features that are not available in any other materials, including 1) a train-the-trainer curriculum; 2) 40 different modules with guides for peer trainers and workshop participants; 3) a CD-ROM with video triggers and slides designed specifically for training purposes; 4) discussion of social justice in relation to clinical trials and 5) an underlying framework which focuses on both content and action based on audience. Through the local delivery of these programs, ENACCT is effectively disseminating and reinforcing the delivery of critical information about cancer clinical trials, increasing the likelihood that all eligible patients are: 1) told about the importance of clinical trials by community leaders/key opinion leaders; 2) told about the option of receiving treatment through a clinical trial by a trusted primary health care provider; 3) better able to initiate inquiries about clinical trials and 4) if eligible, offered the opportunity to join a clinical trial by their oncologist.
2 ENACCT EDUCATION PROGRAM OVERVIEW Educational Program Population target Purpose of Training 1. Clinical Trial Team Training 2. Primary Health Care Provider Training of Trainers (TOT) HEALTH CARE PROVIDER TRAINING PROGRAMS All members of Cancer Clinical Trials Research Team (oncologist, nurse, clinical research associate, outreach staff) Any professional providing 1 on 1 clinical care to patient or client who is a leader in their professional community To improve recruitment consent and accrual processes especially among ethnic and racial minorities Build knowledge and skills to enable them to a) run 2-hour peer workshops (utilizing the modules) about cancer clinical trials that provide CME and b) give brief presentations utilizing content from the modules. 3. Primary Health Care Provider Workshops (run by peer trained trainers - #2 above) Any professional providing 1 on 1 clinical care to patient or client Prompt action on: the importance of referral to local providers who participate in clinical trials the importance of educating patients about the importance of clinical trials as an option for first line treatment 4. Community Leaders Training of Trainers (TOT), hours COMMUNITY LEADER TRAINING PROGRAMS Influential community leaders and cancer survivors Build knowledge and skills to enable them to a) run 1-2 hour peer workshop (utilizing the modules) that educate other community leaders about the importance of cancer clinical trials and b) give brief planned presentations utilizing some content from the modules. Workshops will be customized to best suit the audience. 5. Community Leader Workshops (run by peer trained trainers - #4 above), 1-2 hours Peers of #4 To prompt community leaders to share information about the importance of clinical trials with any community member who may be diagnosed in the future All trainers utilize our tool kit shown here. Screen shots from Trainer Tool kit Page 2
3 ENACCT Health Care Provider Training Programs-Description Two different professional training programs assist primary care providers and oncology staff in optimal referral, recruitment and retention. Continuing education credits are available. Primary Care Providers Need for Clinical Trials Education Although a health care provider s recommendation has an enormous impact on a patient s decision to participate in a clinical trial, data suggest that provider awareness of cancer clinical trials is limited. Primary care physicians do not have sufficient information on available clinical trials, and often leave discussion of clinical research to a patient s oncologist. 3 Most patients would consider a clinical trial if their doctors recommended they do so; 4 one study showed that physician recommendation was the primary factor influencing patients decisions to enroll in a trial. 56 Primary care providers are ideally suited to broach the subject of clinical trials with their patients -- either before or when a definitive cancer diagnosis is made and before making a referral to an oncology specialist for treatment 7. Despite their influence, few primary care providers routinely discuss cancer clinical trials with their patients, with many preferring to leave these discussions to oncologists. 8 Additionally, many providers are unaware of clinical trials that might be available for their patients. 9 The Primary Care Provider Training Program features two interrated components: Train the Trainers Program- This 18-hour (3 hour web, 15 hour classroom) program enables health care providers to become provider trainers and conduct a two-hour workshop with their peers. Two-hour workshops Led by peer trainers, these workshops are designed to increase knowledge and awareness of cancer clinical trials, and provide health care providers with the tools and skills needed to make appropriate referrals, and inform patients of clinical trials as an important option in cancer treatment and care. A number of different modules are available, and each includes trainers guides, participant guides, and slides on a single CD-ROM. Clinical Trial Teams Need for Education It is not surprising that cancer researchers experience difficulty recruiting ethnically diverse populations to clinical trials and retaining their participation. 10 Many researchers lack the expertise to adequately address patient barriers, especially those associated with medically underserved communities. Furthermore, many investigators and their staff lack the skills necessary for conducting culturally sensitive community outreach and education programs, or creating an infrastructure that allows for culturally sensitive patient recruitment and retention. It is important to note that the Federal Government has recently underscored the need for cultural competency training in the research setting, convening a national research team to apply National Standards on Culturally and Linguistically Appropriate Services (CLAS) to the clinical trials process 1. 1 CLAS-ACT (Culturally and Linguistically Appropriate Standards And Clinical Trials) will guide scientists and health professionals in utilizing CLAS standards when designing and recruiting minority patients into new clinical trials. See Page 3
4 Training for Clinical Trial Teams This Training Program features two interrated components that are offered independently: Optimizing Clinical Trials Recruitment and Retention Practices: A Workshop for Cancer Clinical Trial Staff (Designed for Clinical Research Coordinators, Research Nurses, Oncologists currently participating/ interacting with patients in the context of a clinical trial) o This is a 4-hour training program whose goal is to enhance providers conduct of outreach, recruitment and retention of all populations in cancer clinical trials. CLAS 2 Standards and Cancer Clinical Trials: Optimizing Institutions Recruitment and Retention Practices (Designed for institution leadership i.e., administrators, vice presidents, directors of risk management, strategic planning, community outreach or public relations) o This is a 4-hour training program with the goal of assisting institution administrators to implement specific policies to enhance outreach, recruitment and retention services for all populations in cancer clinical trials. ENACCT Community Leader Training Program-Description Community needs for clinical trials education The only nationwide study conducted to date on cancer clinical trials awareness confirmed that the majority of the public knows little about cancer clinical trials: About 85 percent of people with cancer were either unaware or unsure that participation in clinical trials was an option, although about 75 percent said they would have been willing to enroll had they known it was possible. And, of the adults without cancer surveyed, those who reported that they had a high level of understanding of the concept of a clinical trial were more positively inclined toward participation than were those with lower levels of understanding. 11 ENACCT believes that the best educable moment to learn about cancer clinical trials is NOT at the moment of diagnosis. Rather, we need to enhance community literacy about clinical trials and change social norms, so that when a community member is diagnosed, his/her loved ones, friends and health care providers will encourage him or her to inquire about clinical trials as an option for treatment. The Community Leader Training Program empowers community leaders to spread the message about the importance of cancer clinical trials to their peers in interactive 1 hour workshops, with a call to action to spread the word. This peer- to -peer approach includes an open and honest dialogue about clinical research, and helps to: Build on the strengths and resources within the community. Involve communities that have been marginalized by the health care system. Increase trust and bridge cultural gaps between researchers and communities (traditionally a critical barrier in clinical trial outreach and education). Enhance access to clinical trials Promote inquiry about clinical trials 2 Culturally and Linguistically Appropriate Services (CLAS) Standards, recently recognized by the Federal government* as having a strong role in clinical research in their support of the EDICT CLAS-ACT (Culturally and Linguistically Appropriate Services And Clinical Trials) Project, (Sponsored by U.S. Department of Health and Human Services Office of Minority Health National Institutes of Health (NIH) National Center for Minority Health and Health Disparities HHS Office on Women s Health) Page 4
5 The Community Leader Training Program features two interrated components: Train the Trainers program: This 24-hour training program trains a small cadre of community leaders to conduct one-hour educational workshops with their peers One-hour workshops: Led by peer trainers, the goal is to increase knowledge and awareness of cancer clinical trials. A number of different modules are available and each includes trainers guides, participant guides, slides and videos on a single CD-ROM. ~For more information, please contact us at the number above~ ENACCT Lead Trainers Margo Michaels, Executive Director and President/Founder of ENACCT. Ms. Michaels is the lead course author for all ENACCT curricula. A former Education Branch Chief at the National Cancer Institute (NCI), for the last 10 years Ms. Michaels has developed dozens of programs to educate cancer advocates, community leaders, and health care professionals about policy and science issues related to both cancer and cancer clinical trials. She developed NCI s Clinical Trial Ambassador Program, NCI s Clinical Trial Education Series, and the Clinical Research: Affiliates Funding Trials (CRAFT) program at the Susan G. Komen Breast Cancer Foundation in Dallas, TX (now Komen for the Cure). She was the Director of the National Breast Cancer Coalition s Project LEAD in the late 90 s. She holds an M.P.H. in Health Behavior/Health Education from the University of North Carolina School of Public Health. Natasha Blakeney, Training Director, ENACCT. Ms Blakeney has a diverse background in cancer education and outreach, particularly in reaching medically underserved communities and working with health care professionals to improve recruitment and retention in clinical research. She has professional experience with the National Cancer Institute s Cancer Information Service, the National Black Leadership Initiative on Cancer, the Sheps Center for Health Services Research, and the University of Michigan Comprehensive Cancer Center. Natasha received her M.P.H. in Health Behavior/Health Education from the University of North Carolina at Chapel Hill. Ira SenGupta, Executive Director, Cross Cultural Health Care Program. Ms. SenGupta has developed and conducted over 3,000 hours of cultural competency trainings in the past year alone. Ira has conducted major cultural competency institutional assessments and led several community-based research projects. She was the principal investigator for the Office of Minority Health national study of best practices for the CLAS (Culturally and Linguistically Appropriate Services) standards. She has also served on the National Committee for Cultural Competence and the Committee for the Development of Cultural Competence Curriculum and Training Modules for Primary Care Physicians. Ira is also a contributing author and trainer of Bridging the Gap, the premier national training for medical interpreters 1 Cancer clinical trials: A resource guide for outreach, education, and advocacy. Retrieved May 25, 2007, from Boosting Cancer Trial Participation. (2007, May 25). Retrieved May 25, 2007, from 3 Brawley, O. (2004). The study of accrual to clinical trials: Can we learn from studying who enters our studies? Journal of Clinical Oncology, 22(11), CODA. (2000, July). NCI study of Primary Care Physicians Attitudes, Knowledge, and Practices Related to Cancer Clinical Trials: Final Study Results. Silver Spring, MD: Author. 4 Harris Interactive. (2002). There are many reasons why people are reluctant to participate in clinical trials. Health Care News, 2(7). Available at: 5 Kinney, A.Y., Richards, C., Vernon, S. W., & Vogel, V. G. (1998). The effect of physician recommendation on enrollment in the Breast Cancer Chemoprevention Trial. Prev Med, 27(5 Pt 1), Patient Advocate Foundation. Doctors, patients face different barriers to clinical trials. Available at: 7 Aldigé, C. & Stovall, E.L. Conversations in care web-book: Chapter 9 Communicating about clinical trial enrollment: Patients and advocates speak out. Available at #40. 8 Aldigé, C. et al 9 Crosson, K., Eisner, E., Brown, C., & Ter Maat, J. (2001). Primary care physicians attitudes, knowledge, and practices related to cancer clinical trials. J Canc Educ, 16(4), Sateren, W. B., et al. (2002). How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. Journal of Clinical Oncology, 20, ; Klabunde, C.N., et al. (1999) Factors influencing enrollment in clinical trials for cancer treatment. Southern Medical Journal, 92, Comis, R. L., et al. (2000). A quantitative survey of public attitudes towards cancer clinical trials [On-line]. Coalition of National Cancer Cooperative Groups, Cancer Research Foundation of America, Cancer Leadership Council, and Oncology Nursing Society. Available: Comis, R. L., et al. (2003). Public attitudes toward participation in cancer clinical trials. Journal of Clinical Oncology, 21, Page 5
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