Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes - Carolina Breast Cancer Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Structured behavioral intervention.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Neoplasms. Basic parameters: 20 years — 74 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Carolina Breast Cancer Study: Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes in the Carolina Breast Cancer Study, Phase 4
Overview
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.
Detailed description
Study Population will be 3300 participants with invasive breast cancer among women aged 20-74 in 59 North Carolina counties between will be enrolled. Approximately 1,500 Black women (750 aged \<50 and 750 aged ≥50) and 1,750 non-Black women, including approximately 200 who self-identify as American Indian/Alaska Native (875 \<50, 875 ≥50) will be included.
Participants will complete a structured, in-person baseline interview covering breast cancer risk factors, quality of life, comorbidities, initial treatment, follow-up surveys will assess changes in self advocacy. Blood and/or saliva samples will be collected. Participants will provide consent for medical record abstraction and retrieval of tumor blocks.
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 st
Primary outcome measures
- Patient Communication Self-Efficacy Score [Time frame: Baseline, 19 months, every 12-24 months up to 15 years]
Secondary outcome measures (5)
- Tumor Recurrence Events [Time frame: 9 months, 19 months, every 12-24 months up to 15 years]
- Incidence of Second Primary Tumors [Time frame: 9 months, 19 months, every 12-24 months up to 15 years]
- Breast Cancer-Specific and All-Cause Mortality [Time frame: 8 years and 15 years]
- Quality of life measured using the Functional Assessment of Cancer Therapy - Breast (FACT-B) [Time frame: 9 months, 19 months, every 12-24 months up to 15 years]
- Quality of life measured using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [Time frame: 9 months, 19 months, every 12-24 months up to 15 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of North Carolina at Chapel Hill — Chapel Hill
Identifiers
NCT: NCT07214610 · 21-0956