Home › Hereditary Neoplastic Syndromes › NCT05664867

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

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

Who can join

Ages 25 and older · All sexes

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

About the study

The goal of this clinical trial is for researchers to compare the effectiveness of a mainstreamed model of genetic testing (MGT) with an enhanced standard of care model (SOC+) on the uptake of genetic testing among at-risk patients in an urban Federally Qualified Health Center (primary care) setting using a hybrid-effectiveness study design.

Aim 1 is to compare the effectiveness of MGT and SOC+ interventions on the uptake of genetic testing among patients receiving primary care in an urban federally qualified health center (FQHC) system using a randomized trial study design. The hypothesis is that the uptake of testing will be higher among patients receiving services through the MGT compared with the SOC+ model.

Aim 2 is to evaluate the implementation outcomes (acceptability, feasibility and sustainability) and the barriers and facilitators of cancer genetic service delivery approaches within primary care at FQHCs via qualitative interviews with patients, primary care providers and clinic staff, and organizational leaders, guided by the Explore, Prepare, Implement, Sustain (EPIS) implementation framework.

The study will take place at four community health clinics that are part of a Federally Qualified Health Center (FQHC) network in Chicago. Each clinic will use one of two ways of providing cancer genetic services: an enhanced standard of care model that includes patient navigation support (SOC+), or a mainstream genetic testing model (MGT) in which primary care providers offer testing directly. Information such as patients' demographic characteristics, referrals for genetic counseling, completion of genetic testing, and how long it takes to complete testing will be collected from clinic records. Patients, healthcare providers, and clinic staff will also be invited to take part in interviews to share their experiences and perspectives on how each model worked in practice.

What is being tested

• Mainstream Genetic Testing Model (other)
• Enhanced Standard of Care Model (other)

Sponsor: University of Illinois at Chicago · Participants: 80 · Started: Aug 1, 2022

Contact the study team

• Pamela Ganschow, MD · Phone: 312-413-9776
• Angelina Izguerra · Phone: 312-355-0567

Official record on ClinicalTrials.gov — NCT05664867

Locations in the U.S.

Conditions

• Hereditary Neoplastic Syndromes

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.