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

NCT05664867 | Recruiting DMC

• 1 other identifier: 2022-1151
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hereditary Cancer Syndrome

Outcome Measures

Primary Outcomes (1)

• Uptake of genetic testing

  compare the uptake of genetic testing among patients in both models of cancer genetic delivery who screen positive on hereditary cancer risk asserssment (HCRA)

  2 years

Secondary Outcomes (2)

• Time to genetic testing

  2 years

• Evaluate the implementation outcomes (acceptability, feasibility and sustainability) and the barriers and facilitators of cancer genetic service delivery approaches within primary care at FQHCs

  2 years

Study Arms (2)

MGT (Mainstream Genetic Testing) Model

EXPERIMENTAL

The mainstream genetic testing (MGT) model of cancer genetic services involves a non-genetics healthcare provider, such as the primary care provider, who engages patients in the counseling, consenting, and ordering of genetic testing. The provider/care team discloses the genetic test results and refers patients for genetic counseling only when genetic test results are abnormal. By eliminating the pre- and post-test counseling visits with a genetics provider, the MGT model has the potential to provide scalable access to genetic services.

Other: Mainstream Genetic Testing Model

SOC (Standard of Care) Model

ACTIVE COMPARATOR

The enhanced standard of care model (SOC+) is the current referral model of cancer genetic services delivery with an enhancement to include screening for and resources to address health literacy. This model begins with a health care provider's recognition, identification and then referral of a patient to a genetic counselor where genetic testing takes place if appropriate. This model is time- and resource- intensive and may not be scalable.

Other: Enhanced Standard of Care Model

Interventions

Mainstream Genetic Testing Model OTHER

Mainstream Genetic Testing Model of Cancer Genetics Service Delivery

Also known as: MGT

MGT (Mainstream Genetic Testing) Model

Enhanced Standard of Care Model OTHER

Enhanced Standard of Care Model of Cancer Genetic Service Delivery

Also known as: SOC+

SOC (Standard of Care) Model

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Neoplastic Syndromes, Hereditary

Condition Hierarchy (Ancestors)

Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Pamela Ganschow, MD

CONTACT

312-413-9776; pgansch@uic.edu

Angelina Izguerra

CONTACT

312-355-0567; adi5@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: clinical trial with a hybrid effectiveness-implementation quasi-experimental design

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: December 27, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-10

Locations

US (1)