Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes - Carolina Breast Cancer Study

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.

Conditions

• Breast Cancer
• Breast Neoplasms

Interventions

BEHAVIORAL

Structured behavioral intervention

All participants will be prospectively assigned to a structured behavioral intervention embedded within the research process. The goal of the intervention is to improve communication with healthcare providers and enhance self-advocacy during breast cancer care. Components include reflective behavioral self-assessments, symptom reporting tools, regular interaction with nurses and lay health educators, access to webinars and newsletters, patient-centered educational materials, and the return of study results to participants through a report-back process. The behavioral engagement components are standardized and delivered over the first 12 months post-enrollment.

Sponsors & Collaborators

• Breast Cancer Research Foundation

  collaborator OTHER

• Susan G. Komen Breast Cancer Foundation

  collaborator OTHER

• UNC Lineberger Comprehensive Cancer Center

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Max Age

74 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-28

Primary Completion

2044-12-31

Completion

2044-12-31

Countries

• United States

Study Locations