Recruiting

MGT vs. SOC+

Sponsor:

University of Illinois at Chicago

Code:

NCT05664867

Conditions

Hereditary Cancer Syndrome

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Interventions

Mainstream Genetic Testing Model

Enhanced Standard of Care Model

Study Details

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

Study ID

NCT05664867

Start date

Aug 1, 2022

Status verified date

Oct, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: MGT (Mainstream Genetic Testing) Model

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.

active comparator: SOC (Standard of Care) Model

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.

Interventions

Mainstream Genetic Testing Model

Mainstream Genetic Testing Model of Cancer Genetics Service Delivery

Enhanced Standard of Care Model

Enhanced Standard of Care Model of Cancer Genetic Service Delivery

Primary outcome measure

  • Uptake of genetic testing [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Pamela Ganschow, MD

312-413-9776pgansch@uic.edu

Angelina Izguerra

312-355-0567adi5@uic.edu

Locations

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Pamela Ganschow, MD

312 413 9776pgansch@uic.edu

Angelina Izguerra, BPH

312 355 0567adi5@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jan 14, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-01-14.