Bringing genetic testing for hereditary breast and colon cancer into community health centers

Developing and Optimizing Best Practice Solutions for Implementation of Population Based Cancer Genetic Services in Federally Qualified Health Centers

This project tests whether a mainstream genetic testing approach versus an enhanced usual-care approach increases genetic testing among adults at risk for hereditary breast or colon cancer seen in urban community health centers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 25 Years and up
• Sex: All
• Sponsor: University of Illinois at Chicago (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT05664867 on ClinicalTrials.gov

What this trial studies

The trial uses a randomized, hybrid-effectiveness design to compare a mainstreamed genetic testing model (MGT) with an enhanced standard-of-care model (SOC+) delivered in four Federally Qualified Health Center (FQHC) clinics. Aim 1 measures uptake of genetic testing among primary care patients who meet NCCN criteria for hereditary breast or colon cancer syndromes. Aim 2 examines implementation outcomes—acceptability, feasibility, and sustainability—and explores barriers and facilitators through qualitative interviews with patients, primary care clinicians, and staff. The study focuses on adults aged 25 and older who speak English and receive care at participating clinics.

Who should consider this trial

Good fit: Adults age 25 or older who speak English, receive care at one of the participating FQHC clinics, and meet NCCN criteria for hereditary breast or colon cancer testing are ideal candidates.

Not a fit: Patients who do not meet NCCN eligibility, do not receive care at the participating clinics, or who do not speak English are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, this approach could increase identification of people with inherited cancer risk and enable earlier prevention or surveillance, especially for underserved populations.

How similar studies have performed: Mainstreaming genetic testing has shown promise in oncology clinics and some health systems, but randomized data and implementation evidence in urban FQHC primary-care settings remain limited.

Eligibility criteria

Aim 1 and 2 Inclusion Criteria for patients

1. Adults age 25+
2. English speaking
3. 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
4. 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.
5. Patient receiving care from one of the 4 Federally Qualified Health Center clinics enrolled in the clinical trial

Exclusion Criteria:

1. Did not meet the inclusion criteria
2. 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.
3. Not a patient receiving care from the one of the clinics enrolled in the clincial trial

Aim 2

Inclusion Criteria for Providers/Staff:

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

Exclusion Criteria:

1\. Does not meet inclusion criteria above

Where this trial is running

Chicago, Illinois

• University of Illinois Cancer Center — Chicago, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Pamela Ganschow, MD

Conditions Hereditary Cancer Syndrome