Breast CancerRSPH5973-23NCT06760507
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
A study testing Adapted Family History Screening Program in people with Breast Cancer and Ovarian Cancer, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Ovarian Cancer
- What is being tested?
- Adapted Family History Screening Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,209 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Yue Guan, 404-712-1671, yue.guan@emory.edu
Yue Guan
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Breast Cancer, Ovarian Cancer
- Being tested
- Adapted Family History Screening Program
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Family History Screening ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Adapted Family History Screening Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Up to 6 years
Secondary outcomes (8)
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.
Measured: Up to 6 years
Mammogram screening behaviors
Whether eligible patients underwent mammogram screening (Yes/No).
Measured: 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"
Measured: Up to 6 years
Emotional processing
Will evaluate cancer fear based utilizing the FHAT questionnaire, a 10-point Likert scale.
Measured: Up to 6 years
Reach
Measured as the number and percentage of eligible women identified based on clinic site records.
Measured: Up to 6 years
Adoption
Measured as the number and percentage of clinic staff who participate in the research project.
Measured: 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.
Measured: Up to 6 years
Program sustainability
Evaluated as program potential for sustainability using the Clinical Sustainability Assessment Tool (CSAT) survey.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Feb 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Yue Guan, Emory University
- Investigators
- Yue Guan, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760507
- Sponsor's protocol ID
- STUDY00006068
- Other IDs
- P30CA138292, R37CA276317, NCI-2023-05724, RSPH5973-23
- Acronym
- RSPH5973-23
- Status last verified
- Apr 2026
- First submitted
- 18 Dec 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06760507
- Acronym / sponsor ID
- RSPH5973-23 / STUDY00006068
- Conditions
- Breast Cancer, Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,209 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Adapted Family History Screening ProgramThe 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Family History Screening ProgramThe 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. | Other | Aim 2, Arm 2 (Adapted Family History Screening Program) |
Primary outcome
Uptake of family history screening
Time frame: Up to 6 years
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.
Screen result interpretation
Time frame: Up to 6 years
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).
8 secondary outcomes
Uptake of genetic consultation and testing
Time frame: Up to 6 years
Mammogram screening behaviors
Time frame: Up to 6 years
Acceptance of result validity
Time frame: Up to 6 years
Emotional processing
Time frame: Up to 6 years
Reach
Time frame: Up to 6 years
Adoption
Time frame: Up to 6 years
Implementation process
Time frame: Up to 6 years
Program sustainability
Time frame: Up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yue Guan principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Family History Screening Program in people with Breast Cancer and Ovarian Cancer, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Guan, PhD (404-712-1671, yue.guan@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of family history screening (time frame: Up to 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.