Recruiting

Behavioral Intervention

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07214610

Conditions

Breast Cancer

Breast Neoplasms

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Structured behavioral intervention

Study Details

Brief 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

Breast Cancer

Breast Neoplasms

Study ID

NCT07214610

Start date

Nov 28, 2023

Status verified date

Oct, 2025

Completion date

Dec 31, 2044

Anticipated

Primary completion date

Dec 31, 2044

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Newly diagnosed with breast cancer

Participants with newly diagnosed with breast cancer live in 59 North Carolina counties.

Interventions

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 measure

  • Patient Communication Self-Efficacy Score [ Time Frame: Baseline, 19 months, every 12-24 months up to 15 years ]

Central Contacts and Locations

Central contacts

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Melissa A troester, PhD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Oct 10, 2025

Last verified

Oct, 2025

Keywords

  • subtypes of breast cancer
  • genetic factors
  • racial disparities
  • African American (AA)
  • American Indian/Alaska Native (AIAN)
  • tumor biology
  • treatment adherence
  • patient engagement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2025-10-10.