Family History Screening for BRCA-Associated Cancers
(RSPH5973-23 Trial)

Recruiting in Palo Alto (17 mi)

Overseen byYue Guan

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Emory University

No Placebo Group

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.

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.

+8 more

Trial 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

Participant Groups

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.

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.