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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 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.

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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.

Interventions

  • BEHAVIORAL Structured behavioral intervention

Study Locations (1)

North Carolina

  • University of North Carolina at Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 3,300 participants
Start Date 2023-11-28
Est. Completion 2044-12-31
Phase NA

What the Registry Record Tells You About NCT07214610

The ClinicalTrials.gov registry entry for NCT07214610 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 3,300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (18% higher). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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