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NCT07214610 · ClinicalTrials.gov registry record · NA
Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes - Carolina Breast Cancer Study
A NA study of Breast Cancer and Breast Neoplasms, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- NA
- Development phase
- 3,300
- Enrollment target
- 1
- Study location
NCT07214610: Recruiting NA study of Breast Cancer and Breast Neoplasms, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT07214610 is a NA study of Breast Cancer and Breast Neoplasms that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 3,300 participants, above the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (18% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07214610, a NA study of Breast Cancer and Breast Neoplasms, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 3,300 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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 understan
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 |
What NCT07214610 shows while recruiting
NCT07214610 is an interventional study that assigns participants to a tested intervention. Its 3,300 participants enrollment target places it among the larger protocols in the corpus, above the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (18% higher).
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.
NCT07214610 reports a single indexed study location in North Carolina.
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.
What interventions are being tested in trial NCT07214610?
The interventions under investigation include: Structured behavioral intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT07214610?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07214610's enrollment target sits among peer trials
3,300 43rd of 1224 higher than 1,181 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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