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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07214610
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Structured behavioral intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 28, 2023
Status verified
Oct 2025
Primary completion
Dec 31, 2044
Completion
Dec 31, 2044

Study Design

Enrollment
3,300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Newly diagnosed with breast cancer
    Participants with newly diagnosed with breast cancer live in 59 North Carolina counties.

Primary Outcome Measure

Patient Communication Self-Efficacy Score [ Time Frame: Baseline, 19 months, every 12-24 months up to 15 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Heather J Tipaldos
[email protected]
919-966-9438
Melissa A troester, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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