Bringing genetic testing for hereditary breast and colon cancer into community health centers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses a randomized, hybrid-effectiveness design to compare a mainstreamed genetic testing model (MGT) with an enhanced standard-of-care model (SOC+) delivered in four Federally Qualified Health Center (FQHC) clinics. Aim 1 measures uptake of genetic testing among primary care patients who meet NCCN criteria for hereditary breast or colon cancer syndromes. Aim 2 examines implementation outcomes—acceptability, feasibility, and sustainability—and explores barriers and facilitators through qualitative interviews with patients, primary care clinicians, and staff. The study focuses on adults aged 25 and older who speak English and receive care at participating clinics.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Illinois Cancer Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Pamela Ganschow, MD
• Email: pgansch@uic.edu
• Phone: 312-413-9776

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EHR-based approach to boost HBOC genetic testing in at-risk women

  A new EHR tool-based program tests whether computer prompts and real patient resources can help more women with family histories of breast or ovarian cancer get HBOC genetic testing.

  Recruiting Columbia University · New York, New York · NCT07876349

• Hereditary cancer screening offered during obstetrical carrier screening

  This project will test offering hereditary cancer genetic testing to pregnant and preconception patients who are already getting obstetrical carrier screening to see if they want it and can complete testing alongside routine prenatal care.

  Recruiting Columbia University · New York, New York · NCT07195071

• Blood test for early cancer detection in hereditary cancer patients

  This study is testing a new blood test to see if it can help find early tumors in people with hereditary cancer syndromes better than the usual methods.

  Recruiting at 7 sites University Health Network, Toronto · Vancouver, British Columbia and 7 other locations · NCT06726642

• Understanding the immune response in Lynch syndrome patients

  This study is trying to see if certain antibodies in the immune system can help spot early signs of cancer in people with Lynch syndrome.

  Recruiting at 5 sites San Raffaele University · Monrovia, California and 4 other locations · NCT06708429

• Using a chatbot to improve genetic risk assessment for hereditary cancer

  This study is testing if a chatbot can help more patients at risk for hereditary cancer get recommended for genetic testing compared to regular care in a gynecology clinic.

  Recruiting at 4 sites Weill Medical College of Cornell University · Brooklyn, New York and 3 other locations · NCT05562778

• Understanding Li-Fraumeni Syndrome and TP53 Variants

  This study is trying to understand cancer risks in people with Li-Fraumeni Syndrome or TP53 gene changes to help improve prevention and treatment options.

  Recruiting at 3 sites Dana-Farber Cancer Institute · Boston, Massachusetts and 2 other locations · NCT04541654

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.