Carolina Breast Cancer Study: Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes in the Carolina Breast Cancer Study, Phase 4

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 74
Healthy Volunteers: f
View:

• women with invasive breast cancer

• live in 59 counties in North Carolina

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Contact Information
Primary
Heather J Tipaldos
heather_tipaldos@unc.edu
(919) 966-9438
Backup
Melissa A Troester
troester@email.unc.edu
(919) 966-9438
Time Frame
Start Date: 2023-11-28
Estimated Completion Date: 2044-12-31
Participants
Target number of participants: 3300
Treatments
Experimental: Newly diagnosed with breast cancer
Participants with newly diagnosed with breast cancer live in 59 North Carolina counties.
Related Therapeutic Areas
Sponsors
Collaborators: Breast Cancer Research Foundation, Susan G. Komen Breast Cancer Foundation
Leads: UNC Lineberger Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov