NCT07214610 · UNC Lineberger Comprehensive Cancer Center
Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes - Carolina Breast Cancer Study
What this study 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.
View original scientific description
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.
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.
Primary outcome measures
Patient Communication Self-Efficacy Score
Time frame: Baseline, 19 months, every 12-24 months up to 15 years
Patient communication self-efficacy will be measured using the Patient's Communication Perceived Self-Efficacy Scale (PCSS), a validated patient-reported instrument comprising 16 items with a three-factor structure: Provide and Collect Information, Express Concerns and Doubts, and Verify Information. The scale assesses patients' confidence in their ability to communicate effectively with healthcare providers about health concerns, ask questions, express uncertainties, and confirm their understanding. Items are rated on a 5-point Likert scale (1 = not at all confident to 5 = very confident), with total scores ranging from 16 to 80. Higher scores indicate greater perceived communication self-efficacy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chapel Hill, North Carolina
Collaborators
Breast Cancer Research Foundation, Susan G. Komen Breast Cancer Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 10, 2025 · Source of record for eligibility and locations