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Purpose: To increase access of underserved/health disparities communities to National Cancer Institute (NCI) clinical trials, the Radiation Research Program (RRP) piloted a unique model - the Cancer Disparities Research Partnership (CDRP) program. CDRP targeted community hospitals with a limited past NCI funding history and provided funding to establish the infrastructure for their clinical research program.Methods: Initially, 5-year planning phase funding was awarded to six CDRP institutions through a cooperative agreement (U56). Five were subsequently eligible to compete for 5-year implementation phase (U54) funding and three received a second award. Additionally, the NCI Center to Reduce Cancer Health Disparities supported their U56 Patient Navigation programs.Results: Community-based hospitals with little or no clinical trials experience required at least a year to develop the infrastructure and establish community outreach/education and Patient Navigation programs before accrual to clinical trials could begin. Once established, CDRP sites increased their yearly patient accrual mainly to NCI-sponsored cooperative group trials (~60%) and Principal Investigator (PI)/mentor-initiated trials (~30%). The total number of patients accrued on all types of trials was 2,371, while 5,147 patients received navigation services. Conclusions: Despite a historical gap in participation in clinical cancer research, underserved communities are willing/eager to participate. Since a limited number of cooperative group trials address locally advanced diseases seen in health disparities populations, this shortcoming needs to be rectified. Sustainability for these programs remains a challenge. Addressing these gaps through research and public health mechanisms may have an important impact on their health, scientific progress and efforts to increase diversity in NCI clinical trials.

Purpose: To identify sequence variants of the ataxia telangiectasia mutated (ATM) gene and establish their prevalence rate among American Indian (AI) as compared with non-AI cancer patients. Materials and Methods: DNA was isolated from blood samples collected from 100 AI and 100 non-AI cancer patients undergoing radiation therapy, and a blinded assessment of the ATM sequence was conducted. Quantitative PCR assessment of copy number for each exon was also performed. The main outcome measure was the prevalence of ATM variants in the two patient populations. Results: No statistically significant differences for total prevalence of ATM variants among AI and non-AI patients were found. Of the 25 variants identified, five variants had a prevalence of >2%, of which 4 occurred at a rate of >5% in one or both groups. The prevalence of these four variants could meaningfully be compared between the two groups. The only statistically significant difference among the groups was the c.4138C>T variant which is predicted not to affect protein function, seen in 8% of AI versus 0% of non-AI patients (P=0.007). No exonic copy number changes were found in these patients. Conclusions: This study is the first to determine the prevalence of ATM variants in AIs.

Purpose/Objective(s): American Indians (AIs) present with more advanced stages of cancer and, therefore, suffer from higher cancer mortality rates compared to non-AIs. Under the National Cancer Institute Cancer Disparities Research Partnership Program (CDRP), we have been researching methods of improving cancer treatment and outcomes since 2002, for AIs in Western South Dakota, through the Walking Forward (WF) Program.Materials/Methods: This program consists of a) a culturally-tailored patient navigation program that facilitated access to innovative clinical trials in conjunction with a comprehensive educational program encouraging screening and early detection, b), surveys to evaluate barriers to access c) clinical trials focusing on reducing treatment length to facilitate enhanced participation using brachytherapy and intensity modulated radiotherapy (IMRT) for breast and prostate cancer, as AIs live a median of 140 miles from the cancer center, and d) a molecular study (ATM - Ataxia telangectasia mutation) to address whether there is a specific profile that increases toxicity risks. Results: We describe the design and implementation of this program, summary of previously published results, and ongoing research to influence stage at presentation. Some of the critical outcomes include the successful implementation of a community based research program, development of trust within tribal communities, identification of barriers, analysis of nearly 400 navigated cancer patients, clinical trial accrual rate of 10%, and total enrollment of nearly 2,500 AIs on WF research studies. Conclusions: This NCI funded pilot program has achieved some initial measures of success. A research infrastructure has been created in a community setting to address new research questions and interventions. Efforts underway to promote cancer education and screening are presented, as well as applications of the lessons learned to other health disparity populations.