Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Ovarian Cancer
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-01-07
Enrollment: 3209
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed description: PRIMARY OBJECTIVES:

I. 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. (Phase I \[Exploration \& Preparation stages\]) II. Use a multi-site, parallel group, cluster randomized controlled trial to evaluate 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 who are receiving care in up to 6 of 14 public health clinics in Southwest Georgia. (Phase II \[Implementation stage\]) III. Use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to conduct an implementation research evaluation to measure program process indicators (e.g., reach, fidelity, barriers/facilitators) that may influence program implementation and sustainability. (Phase II \[Implementation stage\])

OUTLINE:

AIM 1: Participants attend stakeholder advisory committee meetings over 2 hours monthly for 14 months, may attend interviews and/or complete surveys, and attend discussion forums in support of the adaptation of the existing GA CORE screening program on study.

AIM 2: Participating clinics are cluster randomized to 1 of 2 arms.

Standard Care Arm:

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 complete data entry manually using patient identifiers and clinic codes. All referrals are done manually, and there are no follow-ups for screening-negative results.

Adapted Intervention Arm:

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.

Positive family history screening results in both arms lead to standard follow-up genetic consultation and testing services.

AIM 3: Participants attend interviews or workshop discussions on study.

Eligibility 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

Primary outcomes:
measure: Uptake of family history screening
timeFrame: Up to 6 years
measure: Screen result interpretation
timeFrame: Up to 6 years
Secondary outcomes:
measure: Uptake of genetic consultation and testing
timeFrame: Up to 6 years
measure: Mammogram screening behaviors
timeFrame: Up to 6 years
measure: Acceptance of result validity
timeFrame: Up to 6 years
measure: Emotional processing
timeFrame: Up to 6 years
measure: Reach
timeFrame: Up to 6 years
measure: Adoption
timeFrame: Up to 6 years
measure: Implementation process
timeFrame: Up to 6 years
measure: Program sustainability
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Yue Guan
role: PRINCIPAL_INVESTIGATOR
References: