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

NCT06760507 | Recruiting DMC

• 5 other identifiers: STUDY00006068P30CA138292R37CA276317NCI-2023-05724RSPH5973-23
• Study Type: interventional
• Target: 3,209
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Uptake of family history screening

  Defined as the number and proportion of the women older than 25 years served by the clinics who complete screening tool. Screening uptake rate at each site will be calculated with a 95% confidence interval. Comparison between arms will be carried out using a mixed-effects logistic regression model.

  Up to 6 years

• Screen result interpretation

  Will be evaluated by recall of screen result calculated as the concordance of participants' self-reported screen result and their actual result (correct/incorrect) and understanding of the likelihood of carrying a BRCA1/2 mutation (correct/incorrect).

  Up to 6 years

Secondary Outcomes (8)

• Uptake of genetic consultation and testing

  Up to 6 years

• Mammogram screening behaviors

  Up to 6 years

• Acceptance of result validity

  Up to 6 years

• Emotional processing

  Up to 6 years

• Reach

  Up to 6 years

Study Arms (2)

Aim 2, Arm 1 (Standard Care)

NO 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.

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

EXPERIMENTAL

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.

Other: Adapted Family History Screening Program

Interventions

Adapted Family History Screening Program 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.

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

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Yue Guan

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Guan, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 7, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)