Recruiting

Family History Screening

Sponsor:

Emory University

Code:

NCT06760507

Conditions

Breast Cancer

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

Interventions

Adapted Family History Screening Program

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Ovarian Cancer

Study ID

NCT06760507

Start date

Feb 1, 2025

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

3209 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: Aim 2, Arm 1 (Standard Care)

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.

experimental: Aim 2, Arm 2 (Adapted Family History Screening Program)

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.

Interventions

Adapted Family History Screening Program

The intervention 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.

Primary outcome measure

  • Uptake of family history screening [ Time Frame: Up to 6 years ]
  • Screen result interpretation [ Time Frame: Up to 6 years ]

Central Contacts and Locations

Central contacts

Yue Guan, PhD

404-712-1671yue.guan@emory.edu

Locations

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Yue Guan

404-712-1671yue.guan@emory.edu

Principal Investigator:

Yue Guan

More Information

Sponsor

Emory University

Last update posted

May 26, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-05-26.