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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Adapted Family History Screening Program

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes