3209 Participants Needed

Family History Screening for BRCA-Associated Cancers

(RSPH5973-23 Trial)

YG
Overseen ByYue Guan, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This clinical trial adapts and evaluates the effectiveness of a family history screening program (GA CORE) for increasing uptake of genetic screening for BRCA-associated cancers in women who have received care in rural public health clinics in Southwest Georgia. Brief and low-cost family history-based screening assessments to identify families at high risk for BRCA-associated cancers have been endorsed by national guidelines and public health organizations. Georgia is among the few states to have implemented statewide family history screening for BRCA-associated cancers. Despite its potential, current clinic-based approaches that identify at-risk women are not sustainable and show limited reach. Additionally, uptake of follow-up cancer screening is sub-optimal and solely focuses on women screened as high genetic risk. This trial will adapt the existing family history screening program and then evaluate it's effectiveness for increasing the number and diversity of women who receive a history assessment and subsequent access to risk-based services such as genetic counseling and testing.

Research Team

YG

Yue Guan

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

This trial is for women who have used rural public health clinics in Southwest Georgia and may be at high risk for BRCA-associated cancers like breast or ovarian cancer. It aims to improve genetic screening uptake by adapting a family history screening program.

Inclusion Criteria

I am a state cancer control leader, public health champion, or a patient.
Medical and administrative directors, nurses, and clinic staff from the six participating clinic sites
I am a woman.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation and Preparation

Conduct a multilevel adaptation of GA CORE's existing statewide family history screening program for BRCA-associated cancers to maximize sustainable program reach and improve communication suitability and effectiveness.

14 months
Monthly stakeholder advisory committee meetings, interviews, and discussion forums

Implementation

Evaluate the effectiveness of the adapted program relative to the current screening program in promoting uptake of family history screening and correct screening result interpretation among women ages 25 and older.

Up to 6 years
Regular clinic visits and follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment, including uptake of genetic consultation and testing, and mammogram screening behaviors.

Up to 6 years

Treatment Details

Interventions

  • Adapted Family History Screening Program
Trial Overview The effectiveness of an adapted family history screening program (GA CORE) is being tested to see if it increases the number of women getting assessed and accessing follow-up services, such as genetic counseling and testing, for BRCA-related cancers.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Aim 2, Arm 2 (Adapted Family History Screening Program)Experimental Treatment1 Intervention
The intervention arm includes four key steps designed to enhance the family health screening process. Before the visit, clinics will engage in community outreach using tools such as social media, events, and promotional materials to raise awareness and drive appointment scheduling through the updated GA CORE website 2.0. During the visit, the intervention streamlines the screening process by embedding reminders into workflows and simplifying results communication and documentation. Patients receive theory-based communication materials about their results. After the visit, follow-ups are automated using the updated website 2.0, consolidating data tracking and incorporating risk-stratified communication strategies to encourage appropriate cancer screening behaviors.
Group II: Aim 2, Arm 1 (Standard Care)Active Control1 Intervention
Clinics in the standard care arm follow the existing GA CORE process. Women visiting or calling the clinic are offered FH screening, with public health nurses assisting eligible participants through the GA CORE website. Nurses manually complete data entry using patient identifiers and clinic codes. All referrals are handled manually, and there are no follow-ups for screening-negative results.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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