An interventional study of Adapted Family History Screening Program in Breast Cancer and Ovarian Cancer, sponsored by Emory University. Recruiting at 1 site in United States. Open to female participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Emory University · Not applicable, Interventional, and 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-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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 3,209 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Emory University is the lead sponsor of 1,385 studies on the registry; 235 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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.
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
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.
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.
Time frame: 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).
Time frame: Up to 6 years
Uptake of genetic consultation and testing
Evaluated as the number and proportion of the women screened as high genetic risk who complete pre-test genetic consultation and testing.
Time frame: Up to 6 years
Mammogram screening behaviors
Whether eligible patients underwent mammogram screening (Yes/No).
Time frame: Up to 6 years
Acceptance of result validity
Will assess with a scale in which women respond to statements such as, "The information I received about my risk for hereditary breast and ovarian cancer seems accurate"
Time frame: Up to 6 years
Emotional processing
Will evaluate cancer fear based utilizing the FHAT questionnaire, a 10-point Likert scale.
Time frame: Up to 6 years
Reach
Measured as the number and percentage of eligible women identified based on clinic site records.
Time frame: Up to 6 years
Adoption
Measured as the number and percentage of clinic staff who participate in the research project.
Time frame: Up to 6 years
Implementation process
The implementation process will be qualitatively assessed to evaluate the perceived acceptability and satisfaction of the adapted program, as well as to identify barriers and facilitators to its delivery and service receipt. At the patient level, we will conduct post-intervention interviews with selected women in the adapted intervention arm. At the organization and provider levels, we will host workshop discussions with organizational implementers of the adapted intervention in late Year 5. During these workshops, we will present the findings of the intervention and gather additional feedback on the program implementation process.
Time frame: Up to 6 years
Program sustainability
Evaluated as program potential for sustainability using the Clinical Sustainability Assessment Tool (CSAT) survey.
Time frame: Up to 6 years
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Emory University