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Hereditary Cancer Syndrome clinical trials

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NCT ID: NCT05664867 Withdrawn - Clinical trials for Hereditary Cancer Syndrome

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

TestMiGenes
Start date: August 2023
Phase: N/A
Study type: Interventional

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.