Abstract Adult participation in cancer clinical trials (CCTs) nationally remains less than 5%, with even fewer participants among communities of color. Barriers to participation are experienced by patients, providers, as well as research staff. Efforts to improve diverse populations’ interest and participation in cancer clinical trials requires a multipronged approach targeting key stakeholders. The Education Network to Advance Cancer Clinical Trials (ENACCT) is the only national organization solely devoted to evidence-based, community-centered approaches to CCTs education. In 2006, ENACCT launched the Pilot Education Program (PEP), a 3-year initiative which sought to improve CCT awareness, access, and accrual, particularly among medically underserved populations. Three diverse PEP community sites (Boston MA, Tacoma WA, and Decatur, IL) participated in training of community leaders (CLs) and health care providers (HCPs), using an action-oriented train the trainer curriculum that addressed cancer health disparities, past research abuses, and current patient protections, as well as the significance of diverse CCTs participation as a social justice issue. Multiple training modules, as well as educational “palm cards” were translated to Spanish and Korean. Workshops for CCT staff focused on strategies to improve recruitment and retention practices to reach medically underserved populations, highlighting the role of Culturally and Linguistically Appropriate Services (CLAS) standards in the clinical research setting. PEP reached 461 HCPs (62% nurses), 926 CLs (66% minority) and 61 CCT staff (13% minority) in educational workshops. Four thousand individuals were reached through community presentations and over 49,000 educational palm cards were distributed. Post training, over 60% of CLs trained said they shared messages about CCTs with at least one other person. HCP trainees had more favorable attitudes and beliefs regarding CCTs and HCPs’ role in CCT referral from pre-to post-workshop assessment. Additionally, at first assessment post-training, 81 % of CLs, 95% of HCPs and 94% of CCT staff agreed that equal access to CCTs is a matter of social justice. Nearly 100 unique patient profiles were created via a national CCTs matching service. ENACCT's training overall positively improved recognition of CCTs access and participation as a social justice issue among stakeholders. Successful community based interventions on CCTs must meet the needs of diverse populations by (1) tailoring key education messages to be culturally relevant and (2) building synergistic relationships among stakeholders to reduce barriers to trial access. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):A25.

Abstract Cancer clinical trials (CCTs) are essential to making progress in cancer care, yet many cancer care sites within health care systems struggle with improving adult trial participation, which nationally is less than 5%, even lower among communities of color. Challenges to improving participation include patient barriers such as fear, lack of awareness and costs as well as institutional barriers (limited staff and resources, study design, provider attitudes and behaviors) that can limit patient access to trials, particularly among minority and medically underserved populations. The Education Network to Advance Cancer Clinical Trials (ENACCT) seeks to improve access to CCTs through education and collaboration with communities, health care providers, and researchers. ENACCT's Pilot Education Program (PEP), was a 3-year community-based intervention designed to enhance access, awareness and accrual to trials. Implemented in three communities nationwide, training was targeted to key stakeholders in trial participation, including CCTs staff. Using an interactive learning format, PEP training for CCT staff focused on the impact of culture and changing demographics within the clinical research setting; the relationship of cultural competency and Culturally and Linguistically Appropriate Services (CLAS) Standards to CCTs participation; and assisted CCT staff to design an action plan to adopt CLAS Standards in the conduct of research at one's own institution. Additionally, local sites addressed policy barriers to enhance access. PEP impact was evaluated using pre and post tests, follow-up assessments, as well as interview and focus group data. PEP trained 61 CCTs staff (70% nurses). Post-training, at first assessment, 94% of CCT staff indicated increased commitment to advocate for adoption of CLAS standards within their institutions and 84% indicated intention to discuss with their peers the importance of cultural competency on patient recruitment and retention. Site initiatives to address access barriers included implementation of consent short forms for limited English proficiency patients, use of Six Sigma quality improvement measures to improve hospital recruitment processes and launching city-wide symposia on CCTs reaching community leaders and health care providers. A total of 3027 website sessions and 88 unique patient profiles were created with a national CCTs matching service associated with PEP. Results from PEP suggest that training CCT staff in strategies to enhance cultural competency in the research setting may positively impact awareness and access to CCTs among medically underserved populations. Citation Information: Cancer Epidemiol Biomarkers Prev 2010;19(10 Suppl):A42.

Fewer than 3% of adult cancer patients participate in cancer clinical trials, with rates even lower among ethnic and racial minorities, older adults, rural residents and low-income groups. A coordinated, multi-pronged approach is critical to addressing patient, physician and system barriers to participation. Despite attention paid by many institutions and government agencies on cancer clinical trials, no program has ever focused on community engagement and education regarding cancer clinical research. Community-based cancer clinical trial education interventions are well positioned as an innovative approach to positively impact relevant knowledge, attitudes and behaviors. The Pilot Education Program (PEP), a pilot project of the Education Network to Advance Cancer Clinical Trials (ENACCT), was launched in 2005 in three communities nationwide. The goal of PEP was to demonstrate the impact and feasibility of a comprehensive, community-driven outreach and education intervention to increase awareness about cancer clinical trials, enhance their acceptability, and improve access to them, resulting in greater inquiry and ultimately patient accrual. Specifically, PEP explored 1) how community-focused education efforts can help to spread the word about cancer clinical trials throughout local communities and 2) how community-driven advocacy efforts can help to reduce local access barriers to clinical trials. The pilot utilized a train-the-trainer model to engage health care providers and community leaders while providing educational workshops for clinical trials staff addressing recruitment and retention practices. Community partnerships coordinated efforts to reduce local structural and policy barriers to clinical trials participation, and worked with state and local cancer coalitions and commissions to enhance cancer clinical trials education and improve access. Evaluation data was captured through surveys, interviews, focus groups and field observation. To date, PEP has recruited 75 trainers, and reached 882 community members (63% minority), 374 health care providers (16% minority) and 61 cancer clinical trial staff (18% nurses) through workshops. Overall, nearly 5,800 individuals were exposed to educational activities about cancer clinical trials as part of wider intervention efforts, including community outreach activities and dissemination of educational materials. Sixty-six percent of community leader trainees reached said they spoke to others about cancer clinical trials. Ninety-four percent of health care providers said they were willing to discuss cancer clinical trials with their patients. Among cancer clinical trial staff, 80% indicated intention to work with community groups on cancer clinical trials education. Further, seventy-seven unique patient profiles were created with a national cancer clinical trials matching service associated with PEP. The methods and strategies implemented within PEP appear promising in improving knowledge among community leaders and health care providers, fostering greater peer-to-peer education about cancer clinical trials, and helping to catalyze change in local cancer research systems. These preliminary findings suggest that community-centered interventions can be an effective means of reducing barriers to cancer clinical trials participation.