Actively Recruiting

Phase Not Applicable
Age: 25Years +
All Genders
ID05664867

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

Led by University of Illinois at Chicago · Updated on 2026-01-14

80

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two different models of cancer genetic service delivery to improve access for patients at risk for hereditary breast or colon cancer syndromes in urban Federally Qualified Health Centers (FQHCs). This study compares a mainstream genetic testing model (MGT), where primary care providers directly offer genetic testing, with an enhanced standard of care model (SOC+) that includes patient navigation support alongside referrals to genetic counseling. The goal is to identify which approach leads to higher uptake of genetic testing and to understand barriers and facilitators in these community health settings. The study involves four community health clinics within an FQHC network, each assigned to use either the MGT or SOC+ model. In the MGT model, primary care providers educate, counsel, and order genetic tests directly, referring patients to genetics specialists only if abnormal results occur. The SOC+ model enhances the usual referral process by adding universal electronic hereditary cancer risk assessment and patient navigation to address barriers like financial concerns. Data such as patient demographics, referrals, testing completion, and timing will be collected, and interviews with patients, providers, and staff will explore their experiences with each model. Participants will be adults aged 25 and older who are English-speaking and eligible for genetic testing based on established criteria. The study will collect information from medical records over two years to measure uptake and timing of genetic testing. Qualitative interviews will assess acceptability, feasibility, and sustainability of each service model. This research aims to provide evidence for scalable, equitable genetic services in underserved primary care settings, with participant involvement lasting up to two years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 25Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults age 25 and older
  • English speaking
  • Eligible for cancer genetic testing for hereditary breast or colon cancer syndromes as defined by NCCN criteria
  • Screened positive and agreed to be contacted for virtual or telephone interviews about cancer genetics services
  • Receiving care from one of the four participating Federally Qualified Health Center clinics
Not Eligible

You will not qualify if you...

  • Did not meet the inclusion criteria
  • Did not screen positive on hereditary cancer risk assessment or did not agree to be contacted for interviews
  • Not a patient receiving care from one of the enrolled clinics in the clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person or virtual)

Implementation

Duration - Up to 2 years

Participants receive cancer genetic services through one of two models: the mainstream genetic testing model where genetic testing is integrated into primary care visits; or the enhanced standard of care model which includes referral to genetic counseling with additional support for health literacy.

Visits occur during primary care appointments as part of routine healthcare; additional contacts may occur depending on the model assigned

Follow-up

Duration - Up to 2 years

Participants are observed to evaluate uptake of genetic testing, time to testing, and implementation outcomes including acceptability, feasibility, and sustainability of the genetic service delivery approaches.

Data collected through electronic medical records; some participants may have interviews via phone or virtual visits

Trial Site Locations

Total: 1 location

1

University of Illinois Cancer Center

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

P

Pamela Ganschow, MD

A

Angelina Izguerra

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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