Image

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

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

Recruiting
25 years and older
All
Phase N/A

Powered by AI

Overview

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.

Description

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.

Eligibility

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

Study details
    Hereditary Cancer Syndrome

NCT05664867

University of Illinois at Chicago

21 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.