Implementation of Population Cancer Genetic Services in Federally Qualified Health Centers (FQHC)

More than 15 years after the release of evidence-based guidelines recommending hereditary cancer risk assessment and testing for at-risk individuals, fewer than one in five eligible patients receive this care. Utilization of cancer genetic services remains substantially lower among racial and ethnic minority populations. Addressing inequities in access to these services is essential, as approximately 10 to 15 percent of cancers are linked to inherited mutations, and early identification of high-risk individuals can support prevention and early detection strategies that reduce disparities in cancer outcomes.

Multiple social determinants of health (SDoH) contribute to limited access to genetic services among underserved populations. At the clinic level, many community health centers have limited capacity to systematically identify at-risk patients, employ few or no genetic specialists, and must rely on external systems for genetic counseling and testing. At the provider level, primary care clinicians often report low confidence and limited training in cancer genetics, while genetic specialists may have limited presence or integration in these care settings. At the patient level, structural, economic, and cultural barriers continue to restrict engagement in genetic testing and counseling.

This project will evaluate and compare two models of cancer genetic service delivery in primary care to improve equitable access among patients served by Federally Qualified Health Centers (FQHCs). The enhanced standard of care model (SOC+) uses universal electronic hereditary cancer risk assessment (HCRA) to identify eligible patients, combined with patient navigation to address individual barriers such as financial concerns and literacy needs. The mainstream genetic testing model (MGT) embeds genetic testing directly into primary care visits, allowing patients to receive education, counseling, and test ordering from their primary care provider without referral to specialty care.

Aim 1: Compare the effectiveness of MGT and SOC+ on uptake of genetic testing among minority patients receiving primary care within an urban FQHC system.

Aim 2: Evaluate implementation outcomes (acceptability, feasibility, and sustainability) and identify barriers and facilitators to cancer genetic service delivery in primary care using qualitative interviews with patients, providers, and clinic staff, guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.

A quasi-experimental design will be used across four FQHC clinics, with each clinic assigned to one of the two models, two SOC+ and two MGT. Demographic and service utilization data, including referrals, testing completion, and time-to-test intervals, will be collected from the electronic medical record. Semi-structured interviews with patients, providers, and staff will further explore experiences and perceptions of each model.

This work will generate actionable evidence on scalable and sustainable approaches to delivering guideline-based genetic services in underserved primary care settings. Findings will inform best practices to reduce inequities in access to precision cancer prevention and early detection services.

Aim 1 and 2 Inclusion Criteria for patients

• Adults age 25+
• English speaking
• Identified as eligible for cancer genetic testing for a hereditary breast or colon cancer syndrome (e.g., BRCA, Lynch or familial polyposis syndrome) as defined by NCCN criteria45-46
• Screened positive and agreed to have study staff contact them in the future to participate in virtual/telephone interviews about their experiences with cancer genetics services.
• Patient receiving care from one of the 4 Federally Qualified Health Center clinics enrolled in the clinical trial

Exclusion criteria

• Did not meet the inclusion criteria
• Did not screen positive on HCRA and/ or did not agree to have study staff contact them in the future to participate in virtual/telephone interviews about their experiences with cancer genetics services.
• Not a patient receiving care from the one of the clinics enrolled in the clincial trial

Aim 2

Inclusion criteria

for Providers/Staff:

• Provider or staff member at one of the 4 clinics participating in the clinical trial
• English speaking

Exclusion criteria

• Does not meet inclusion criteria above