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Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes - Carolina Breast Cancer Study
NCT07214610 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- BEHAVIORAL Structured behavioral intervention
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,300 participants |
| Start Date | 2023-11-28 |
| Est. Completion | 2044-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07214610
The ClinicalTrials.gov registry entry for NCT07214610 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 374 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which Structured behavioral intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07214610 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07214610 about?
NCT07214610 is a clinical study titled "Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes - Carolina Breast Cancer Study". 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 unco...
What is the current status of trial NCT07214610?
This trial is currently recruiting. It is a NA study. The enrollment target is 3,300 participants. The study started on 2023-11-28. Estimated completion is 2044-12-31.
What conditions does trial NCT07214610 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07214610?
The interventions under investigation include: Structured behavioral intervention (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07214610?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 374 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07214610 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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