Integrating biological, clinical, and behavioral factors to improve breast cancer outcomes in North Carolina
Carolina Breast Cancer Study: Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes in the Carolina Breast Cancer Study, Phase 4
This project will test whether adding a structured behavioral program to biological and clinical data can help women aged 20–74 with invasive breast cancer communicate better with providers, improve self-advocacy and treatment adherence, and ultimately improve outcomes, with intentional inclusion of Black and American Indian/Alaska Native participants in 59 North Carolina counties.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3300 (estimated) |
| Ages | 20 Years to 74 Years |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07214610 on ClinicalTrials.gov |
What this trial studies
Phase 4 of the Carolina Breast Cancer Study will enroll about 3,300 women aged 20–74 with invasive breast cancer from 59 counties in North Carolina, oversampling Black and American Indian/Alaska Native participants to address disparities. Participants will complete an in-person baseline interview, provide blood or saliva samples, and consent to medical record abstraction and tumor block retrieval. A structured, in-person behavioral intervention focused on health communication and self-advocacy will be delivered, with follow-up surveys to track changes in self-advocacy, treatment adherence, and patient-reported outcomes. The study links behavioral, clinical, and molecular data to determine whether non-biologic factors help explain persistent outcome differences across racial groups.
Who should consider this trial
Good fit: Women aged 20–74 with invasive breast cancer who live in one of the 59 specified North Carolina counties are ideal candidates, including the targeted enrollment groups of Black and American Indian/Alaska Native women.
Not a fit: Women with ductal carcinoma in situ (DCIS) and people who live outside the 59 specified North Carolina counties are not eligible and would not benefit from this study's interventions or data collection.
Why it matters
Potential benefit: If successful, the approach could improve patient–provider communication, increase treatment adherence, reduce racial disparities, and improve clinical and quality-of-life outcomes for women with invasive breast cancer.
How similar studies have performed: Previous phases of the Carolina Breast Cancer Study have identified molecular and epidemiologic differences by subtype and race, and behavioral interventions have improved communication in other settings, but combining deep molecular data with a structured behavioral program in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women with invasive breast cancer * live in 59 counties in North Carolina Exclusion Criteria: * women with ductal carcinoma in situ (DCIS) * live outside of 59 counties of North Carolina
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Heather J Tipaldos
- Email: heather_tipaldos@unc.edu
- Phone: (919) 966-9438
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.