Actively Recruiting
Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes - Carolina Breast Cancer Study
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-10-10
3300
Participants Needed
1
Research Sites
1100 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
B
Breast Cancer Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase 4 of the Carolina Breast Cancer Study (CBCS4) builds on prior phases that examined molecular and epidemiologic differences in breast cancer types and outcomes. Previous findings showed that certain breast cancer subtypes and genetic factors are linked to higher risks. While prior research uncovered subtype-specific risks and relevant genetic loci, persistent disparities especially among African American (AA) and American Indian/Alaska Native (AIAN) women suggest that tumor biology alone does not fully explain outcome differences. Other important factors, like access to healthcare, treatment adherence, patient engagement must also be evaluated. In addition to collecting biological and clinical data, participants will receive a structured behavioral intervention designed to improve communication with providers and self-advocacy during cancer care. This phase includes a structured behavioral intervention designed to improve health communication and self-advocacy, both of which are hypothesized to improve health outcomes. All participants are prospectively assigned to this single-arm intervention, which includes educational resources, symptom reporting tools, reflective self-assessments, and regular engagement with trained study staff over a defined timeline. This study assesses whether structured research participation can positively influence patient behavior and ultimately reduce disparities in breast cancer care. This study also aims to better understand etiology and prognosis of breast cancer, including subtypes such as Luminal A and B, Basal-like, and Human Epidermal Growth Factor Receptor 2 positive (HER2+) / estrogen receptor negative (ER-) and to address disparities driven by both biology and systemic barriers.
CONDITIONS
Official Title
Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes - Carolina Breast Cancer Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with invasive breast cancer
- Live in 59 counties in North Carolina
- Aged 20 to 74 years
You will not qualify if you...
- Women with ductal carcinoma in situ (DCIS)
- Live outside of the 59 counties of North Carolina
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
H
Heather J Tipaldos
CONTACT
M
Melissa A Troester
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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