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NCT05664867
Implementation of Population Breast Cancer Genetic Services in Federally Qualified Health Centers (FQHC)
Conditions: Hereditary Cancer Syndrome
Sex: All
Ages: 25 Years – N/A
Phase: NA
Enrollment: 130
Sponsor: University of Illinois at Chicago
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 Black 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 MGT compared with 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.Randomization of cancer genetic service models will occur at the clinic level.
Participants (patients, provider and staff) will be recruited to participate in interviews about their experience with each model of care in the clinical trial.
Eligibility Criteria
Aim 1 and 2 Inclusion Criteria for patientsAdults age 25+English speakingSelf identifies race as African American or BlackIdentified 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 criteria45-46Screened 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 2 Mile Square Health Centers enrolled in the clinical trialExclusion Criteria:Did not meet the inclusion criteriaDid 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 Mile Square Health Centers enrolled in the clincial trialAim 2Inclusion Criteria for Providers/Staff:Provider or staff member at one of the 2 MSHC clinics enrolled in the clinical trialEnglish speakingExclusion Criteria:1. Does not meet inclusion criteria above
Source: ClinicalTrials.gov (NCT05664867). StuddyBuddy aggregates publicly available trial information.