Genetic Testing Models for Breast Cancer

(TestMiGenes Trial)

Overseen By Angelina Izguerra

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the better method for encouraging genetic testing among individuals at risk for breast or colon cancer. It compares two approaches: the Mainstream Genetic Testing Model, where primary care doctors directly offer genetic tests, and the Enhanced Standard of Care Model, where patients receive referrals to a genetic counselor with additional support. The trial targets patients at specific Chicago clinics who qualify for genetic testing due to potential hereditary cancer risks. Participants will help researchers identify which method is more effective and user-friendly in everyday healthcare settings. As an unphased trial, this study allows participants to contribute to significant research that could enhance genetic testing processes for future patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on genetic testing models, so it's unlikely that your medications would be affected, but you should confirm with the trial staff.

What prior data suggests that these genetic testing models are safe?

Research shows that the mainstream genetic testing (MGT) model is safe and well-accepted by patients. Studies have found that 91% of patients choose to participate and are generally satisfied with the process. Most patients experience little regret or distress after testing, indicating comfort and manageability.

The MGT model has not reported any serious side effects. Patients usually find the process easy because their primary care doctors handle the testing, and genetic counseling is only needed if results are unusual.

In summary, current evidence suggests that genetic testing through the MGT model is safe, well-received, and effective in encouraging breast cancer testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mainstream Genetic Testing (MGT) model for breast cancer genetic services because it streamlines the process by involving non-genetics healthcare providers, like primary care doctors, directly in genetic testing. This approach eliminates the need for separate pre- and post-test counseling visits with a genetics specialist, making it more scalable and accessible. In contrast, the enhanced Standard of Care (SOC) model is resource-intensive, requiring referrals to genetic counselors for testing, which can be a barrier to access. By simplifying the process, the MGT model could significantly expand access to genetic testing, potentially leading to earlier detection and personalized care.

What evidence suggests that this trial's treatments could be effective for increasing genetic testing uptake in breast cancer?

This trial will compare two models for genetic testing in breast cancer: the Mainstream Genetic Testing (MGT) model and the enhanced Standard of Care (SOC+) model. Research has shown that the MGT model results in a high rate of genetic testing, with about 91% participation across various cancer types. Patients using this method report high satisfaction and experience little regret or stress after testing. Studies have found that MGT significantly increases testing rates among breast cancer patients. The MGT model simplifies the process by allowing primary care doctors to manage the testing, making it more accessible. In contrast, the SOC+ model involves more steps and may be harder to expand. Overall, the MGT model provides a simpler and more satisfying experience for patients seeking genetic testing for breast cancer. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults over 25 who may need genetic testing for hereditary breast or colon cancer syndromes like BRCA, and are patients at certain health centers in Chicago. They must be English-speaking African American or Black individuals willing to discuss their experiences.

Inclusion Criteria

English speaking

Aim 1 and 2 Inclusion Criteria for patients

Self identifies race as African American or Black

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of MGT and SOC+ models to evaluate uptake of genetic testing and service delivery outcomes

2 years

Regular visits as per clinic schedule

Follow-up

Participants are monitored for the effectiveness of genetic service delivery and uptake of genetic testing

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Standard of Care Model
• Mainstream Genetic Testing Model

Trial Overview Researchers are comparing two models of genetic testing services: a mainstream model where primary care providers offer direct testing, and an enhanced standard care with patient navigation support. The study aims to see which model increases the uptake of genetic tests.

How Is the Trial Designed?

Group I: MGT (Mainstream Genetic Testing) Model Experimental Treatment 1 Intervention

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.

Group II: SOC (Standard of Care) Model Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Citations

1. ajog.org ajog.org/article/S0002-9378(25)00259-5/fulltext

Uptake and patient-related outcomes of mainstreaming ... Key findings. The overall uptake of mainstreaming genetic testing across all cancer types was 91%. Mainstreaming was associated with high patient satisfaction ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937825002595

Uptake and patient-related outcomes of mainstreaming ... Mainstreaming genetic testing uptake is associated with high uptake and satisfaction, and low decision conflict, regret, and post-test distress.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2734071

Evaluation of Cancer-Based Criteria for Use in Mainstream ... In this study of 1184 individuals, we estimate that simple, cancer-based criteria may identify patients with breast cancer eligible for genetic ...

4. breast-cancer-research.biomedcentral.com breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-025-02081-y

The impact of a mainstream genetic testing pathway and ... Recent studies have shown a positive relationship between MGT and the uptake of genetic testing in patients with breast cancer [9,10,11].

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12257806/

The impact of a mainstream genetic testing pathway and ... Genetic testing uptake was 80% for patients with a breast cancer diagnosis < 40, 77% for patients with TNBC diagnosed < 60, 44% for patients ...