Family history screening program for BRCA-related cancers in rural clinics
Evaluating an Evidence-Based Family History Screening Program Adapted to Increase Reach and Uptake of Screening for BRCA-Associated Cancers in Rural Public Health Clinics
NA · Emory University · NCT06760507
This study is testing a new family history screening program to see if it can help more women in rural Georgia get genetic testing for BRCA-related cancers.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 3209 (estimated) |
| Ages | 25 Years and up |
| Sex | Female |
| Sponsor | Emory University (other) |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06760507 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates an adapted family history screening program aimed at increasing the uptake of genetic screening for BRCA-associated cancers among women in rural public health clinics in Southwest Georgia. The program, known as GA CORE, will be modified to enhance its reach and effectiveness, utilizing a multi-site, cluster randomized controlled trial design. Participants will engage in stakeholder meetings, discussions, and surveys to inform the adaptation process, while the effectiveness of the new program will be compared to the existing standard care approach. The study will also assess implementation factors using the RE-AIM framework to ensure sustainability and effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 25 and older who have received care at participating public health clinics in Southwest Georgia.
Not a fit: Patients who do not speak English or are under 25 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly increase the number of women screened for BRCA-associated cancers, leading to earlier detection and better outcomes.
How similar studies have performed: Other studies have shown success with similar family history screening approaches, indicating potential for effective implementation in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AIM 1 STAKEHOLDER ADVISORY COMMITTEE: 10 stakeholders representing three constituencies: state cancer control leaders (n=2), participating public health district champions (n=4) (i.e., administrative directors, nurses, clinic staff) and patients (n=4) (i.e., women, age 25 and older who receive their care in the Southwest district) * AIM 1 DISCUSSION FORUM: 25 years or older * AIM 1 DISCUSSION FORUM: Women * AIM 1 DISCUSSION FORUM: English-speaker * AIM 1 DISCUSSION FORUM: Have completed family history screening during the first 3 months of the project at one of 14 public health clinics in Southwest district * AIM 1 ORGANIZATIONAL STAKEHOLDER INTERVIEW: Organizational stakeholders (i.e., medical directors, nurses, and clinic staff) at the 14 clinic sites in Southwest district * AIM 2: Women * AIM 2: Ages 25 and older * AIM 2: Who can read English * AIM 2: Have ever been seen in Women's Health Section through one of participating public health clinics in Southwest district * AIM 3 POST-INTERVENTION INTERVIEW: Participants from aim 2, regardless of whether they completed the recommended genetic services or not (e.g. complete telegenetic session or genetic testing) * AIM 3 WORKSHOP DISCUSSION: Medical and administrative directors, nurses, and clinic staff from the six participating clinic sites
Where this trial is running
Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Yue Guan — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Yue Guan, PhD
- Email: yue.guan@emory.edu
- Phone: 404-712-1671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Ovarian Cancer