Family History Screening for BRCA-Associated Cancers

(RSPH5973-23 Trial)

Overseen By Yue Guan, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Men, Under 25, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3209 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve a family history screening program to help more women in rural Southwest Georgia access genetic screening for BRCA-associated cancers. The trial tests two methods: a standard care approach and an enhanced program, the Adapted Family History Screening Program, which uses outreach and follow-ups to boost awareness and screening. Women who have received care at public health clinics in this area and are interested in genetic testing for cancer risk might be a good fit for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to improving access to genetic screening in underserved communities.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that this family history screening program is safe?

Research has shown that using family history to screen for BRCA-related cancers safely identifies individuals at higher risk. National guidelines recommend these screenings to pinpoint those who might benefit from further genetic testing and counseling.

Studies have found this screening method manageable for participants, as it primarily involves reviewing family medical history. There are no major safety concerns since it is non-invasive and does not require internal procedures.

Participants in similar programs have not reported negative effects, as it only involves sharing information about family health history. Overall, public health organizations support the family history screening program, considering it safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Adapted Family History Screening Program because it streamlines and modernizes the way family health history is used to assess cancer risk. Unlike the standard approach, which relies on manual data entry and lacks follow-up for negative results, this program uses an updated website to automate follow-ups and track data efficiently. It also incorporates community outreach and risk-stratified communication strategies to enhance patient engagement and encourage proactive cancer screening behaviors. This innovative process aims to make cancer risk screening more accessible and effective, potentially leading to earlier detection and treatment.

What evidence suggests that this adapted family history screening program is effective for increasing genetic screening uptake for BRCA-associated cancers?

Research has shown that checking family history can identify women at high risk for certain cancers linked to BRCA genes. Studies have found that these checks lead to more women receiving genetic testing and advice. This trial tests the Adapted Family History Screening Program to streamline the assessment and follow-up process. Previous findings suggest that this approach could help more women access necessary information and services. Although some individuals with BRCA mutations might still be missed, the adapted program aims to enhance the reach and effectiveness of these screenings. ^{1 6 7 8 9}

Who Is on the Research Team?

Yue Guan

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

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

Have completed family history screening during the first 3 months of the project at one of 14 public health clinics in Southwest district

Organizational stakeholders at the 14 clinic sites in Southwest district

Have ever been seen in Women's Health Section through one of participating public health clinics in Southwest district

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Aim 2, Arm 2 (Adapted Family History Screening Program) Experimental Treatment 1 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 Control 1 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.

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+

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06760507/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

Evaluating an Evidence-Based Family History Screening ... This clinical trial adapts and evaluates the effectiveness of a family history screening program (GA CORE) for increasing uptake of genetic screening for BRCA- ...

2. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-025-02935-6

Adaptation and pilot implementation of a hereditary cancer ... Family history-based risk assessment for hereditary breast and ovarian cancer is guideline-recommended but clinical implementation remains ...

3. withpower.com withpower.com/trial/family-history-screening-for-brca-associated-cancers-30b3f

Family History Screening for BRCA-Associated Cancers This clinical trial adapts and evaluates the effectiveness of a family history screening program (GA CORE) for increasing uptake of genetic screening for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4301704/

Cost-effectiveness of Population Screening for BRCA ... We found that more than 50% of BRCA carriers are missed by the FH-based approach, which is consistent with some earlier reports in which 40% to 63% (1–3) of ...

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1479966/full

Cost-effectiveness analysis of population-based BRCA1/2 ... Incorporating family-history-based BRCA1/2 testing into breast and ovarian cancer screening programs is cost-effective in China and warrants promotion.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9382180/

Screening for Individuals at Risk for Hereditary Breast and ... Screening for individuals at risk for hereditary breast and ovarian cancer: a statewide initiative, Georgia, 2012–2020.

7. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/brca-related-cancer-risk-assessment-genetic-counseling-and-genetic-testing

BRCA-Related Cancer: Risk Assessment, Genetic ... BRCA1 testing in families with hereditary breast-ovarian cancer. A prospective study of patient decision making and outcomes. JAMA. 1996;275 ...

8. nature.com nature.com/articles/s44276-024-00099-x

Why is genetic testing underutilized worldwide? The case ... Further, preventive salpingo-oophorectomy has been shown to reduce breast cancer fatality in women with BRCA1, BRCA2, and CHEK2 mutations [34,35 ...

9. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)31645-X/fulltext

Prevention and screening in BRCA mutation carriers ... The guidelines will focus on cancer prevention and screening among individuals known to harbour a pathogenic BRCA1/2 mutation. The presence of a BRCA1 or BRCA2 ...