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NCT05664867 · ClinicalTrials.gov registry record · NA
Implementation of Population Cancer Genetic Services in Federally Qualified Health Centers (FQHC)
A NA study of Hereditary Cancer Syndrome, sponsored by University of Illinois at Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05664867: Recruiting NA study of Hereditary Cancer Syndrome, sponsored by University of Illinois at Chicago.
NCT05664867 is a NA study of Hereditary Cancer Syndrome that is actively recruiting participants, run by University of Illinois at Chicago. The registered enrollment target is 80 participants, below the 738-participant average among 4 other Hereditary Cancer Syndrome trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05664867, a NA study of Hereditary Cancer Syndrome, is actively recruiting participants, sponsored by University of Illinois at Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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 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 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. The study will take place at four community health clinics that are part of a Federally Qualified Health Center (FQHC) network in Chicago. Each clinic will use one of two ways of providing cancer genetic services: an enhanced standard of care model that includes patient navigation support (SOC+), or a mainstream genetic testing model (MGT) in which primary care providers offer testing directly. Information such as patients' demographic characteristics, referrals for genetic counseling, completion of genetic testing, and how long it takes to complete testing will be collected from clinic records. Patients, healthcare providers, and clinic staff will also be invited to take part in interviews to share their experiences and perspectives on how each model worked in practice.
Primary Outcome
compare the uptake of genetic testing among patients in both models of cancer genetic delivery who screen positive on hereditary cancer risk asserssment (HCRA)
Conditions Studied
Interventions
- OTHER Mainstream Genetic Testing Model
- OTHER Enhanced Standard of Care Model
Study Locations (1)
Illinois
- University of Illinois Cancer Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2027-06 |
| Phase | NA |
What NCT05664867 shows while recruiting
NCT05664867 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 738-participant average among 4 other Hereditary Cancer Syndrome trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Hereditary Cancer Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Mainstream Genetic Testing Model is the first listed.
NCT05664867 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05664867 about?
NCT05664867 is a clinical study titled "Implementation of Population Cancer Genetic Services in Federally Qualified Health Centers (FQHC)". 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...
What is the current status of trial NCT05664867?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2022-08-01. Estimated completion is 2027-06.
What conditions does trial NCT05664867 study?
This clinical trial studies the following conditions: Hereditary Cancer Syndrome.
What interventions are being tested in trial NCT05664867?
The interventions under investigation include: Mainstream Genetic Testing Model (OTHER), Enhanced Standard of Care Model (OTHER).
Who is sponsoring clinical trial NCT05664867?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05664867 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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