Carolina Breast Cancer Study: Improving Outcomes Through Communication and Self-Advocacy

This study, called the Carolina Breast Cancer Study (CBCS4), is looking at how different factors – biological (like genetics), clinical (like treatments), and behavioral (like how you talk to your doctors) – affect breast cancer outcomes. It's testing a "structured behavioral intervention" to help you communicate better with your healthcare providers and advocate for yourself during breast cancer care. The study aims to enroll 3300 women, aged 20 to 74, who have invasive breast cancer and live in 59 counties in North Carolina. Success will be measured by changes in your patient communication self-efficacy score (how confident you feel communicating with your doctors) over time. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 3300 participants. All participants will receive a structured behavioral intervention.
What's involved
You will complete an in-person baseline interview and follow-up surveys. Blood and/or saliva samples will be collected, and you will consent to medical record abstraction and tumor block retrieval.
Compensation
Not stated in the trial record.
Follow-up
Your patient communication self-efficacy score will be measured at baseline, 19 months, and then every 12-24 months for up to 15 years.

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NCT07214610

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

Recruiting
NAAges 20–74InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~3,300 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:Structured behavioral intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient Communication Self-Efficacy Score
Measured over Baseline, 19 months, every 12-24 months up to 15 years
Breast Cancer
Breast Neoplasms
1 sites across 1 states
North Carolina1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

women with invasive breast cancer
live in 59 counties in North Carolina

Exclusion

women with ductal carcinoma in situ (DCIS)
live outside of 59 counties of North Carolina
  • Patient Communication Self-Efficacy ScoreBaseline, 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.