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

RecruitingNAAges 25 Years - anyAllUniversity of Illinois at Chicago
NCT05664867 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Mainstream Genetic Testing Model
  • Enhanced Standard of Care Model
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Where

1 site
University of Illinois Cancer Center
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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