Only 3% of cancer patients participate in cancer clinical trials (CCTs). A number of barriers to participation, particularly for minority groups, can be addressed through community-focused education and advocacy efforts. Working with community partnerships, a pilot program sought to change knowledge, attitudes, and role behaviors among community leaders, primary care providers (PCPs), and clinical researchers about CCTs, to increase patient awareness of and participation in CCTs. A mixed method evaluation utilized quantitative analysis of surveys administered to participants during the program period (2006–2008) and qualitative data from interviews with key participants. Programmatic efforts were effective in increasing knowledge and training community leaders and PCPs to disseminate messages about clinical trials, and ultimately increasing patient inquiries about local trials. Training improved cultural competency skills among clinical researchers to recruit and retain CCT participants. Partnerships fostered new processes and structures to facilitate CCT participation in their communities. Clinical trials education and advocacy efforts through community partnerships have an important role in enhancing clinical trial access and in increasing clinical trial participation. Oncologists’ involvement in and leadership of such partnerships are critical to promoting CCT accrual, particularly for minority groups.

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.

e16555 Background: Although cancer clinical trials (CCTs) help achieve progress in cancer care, trial participation among adult cancer patients remains at only 3%, with rates lower among minorities and the medically underserved. Enhanced community engagement can lead to greater awareness, access, and ultimately, patient accrual. Methods: The Education Network to Advance Cancer Clinical Trials (ENACCT) launched a 3-year, community-centered Pilot Education Program (PEP) in 3 communities nationwide to increase knowledge among community leaders (CLs), health care providers (HCPs) and CCT staff, improve access, and increase patient inquiries about trials. Additionally, local sites worked addressed policy barriers to enhance access. PEP impact was evaluated using web-based surveys, interviews, focus groups and field observation. Results: Seventy-five trainers were recruited among CLs (n = 53) and HCPs (n = 22). PEP trained 926 CLs (66% minority), 461 HCPs (62% nurses) and 61 CCTs staff. Additionally 4,000 individuals were reached through community presentations and 49,000 educational palm cards distributed. Among evaluation respondents, community leader trainees had favorable attitudes and beliefs about CCTs at first assessment and over time, with increased intention to talk to others. Health care provider trainees had more favorable attitudes and beliefs regarding their role in referral to CCTs at posttest compared to baseline. CCT staff indicated increased understanding of patient challenges to CCTs participation and intention to advocate for implementation of cultural and linguistically appropriate service standards (CLAS) within their institution. Site initiatives to address access barriers included implementation of consent short forms, Six Sigma quality improvement measures to enhance recruitment processes and city-wide symposia on CCTs reaching CLs and HCPs. To date, 3,027 website sessions and 88 unique patient profiles have been created with a national CCTs matching service associated with PEP. Conclusions: Findings from ENACCT's PEP suggest community-centered interventions can be an effective means of enhancing cancer clinical trials participation. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca Lilly

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.

e17514 Background: While nearly 20% of adult cancer patients are eligible for cancer clinical trials, less than 3% of cancer patients participate. Rates of participation are lower among communities of color and the medically underserved. Enhanced community engagement and provider training about cancer clinical trials can potentially result in greater awareness, access, and ultimately, patient accrual. Methods: A three-year Pilot Education Program was developed to explore the impact and feasibility of a community-driven outreach and education intervention focusing on community members, community health care providers, and cancer researchers in three medically underserved communities. Using a train-the-trainer model, PEP sought to raise clinical trial awareness among peers and encourage public inquiries about clinical trials. Workshops for clinical trials staff addressed recruitment and retention practices. Additionally, community sites worked to reduce local policy barriers to clinical trials participation.PEP used web-based surveys, interviews, focus groups and field observation to evaluate impact. Results: Seventy-five trainers were recruited. PEP reached 882 community members (63% minority), 374 health care providers (16% minority) and 61 cancer clinical trial staff. Approximately 5,800 individuals were exposed to educational activities through extended community outreach activities and dissemination of educational materials. Among those completing evaluation surveys, 66% of community leader trainees said they spoke to others about cancer clinical trials. Seventy-two percent of health care providers agreed their role is to inform patients about the possibility of receiving treatment through a clinical trial. Among cancer clinical trial staff, 80% indicated intention to work with community groups on cancer clinical trials education. Seventy-seven unique patient profiles were created with a national cancer clinical trials matching service also associated with PEP. Conclusions: Results from ENACCT's Pilot Education Program suggest promise in improving knowledge among community leaders and health care providers, and fostering greater peer-to-peer education about cancer clinical trials. [Table: see text]