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

NCT07214610 | Recruiting DMC

• 1 other identifier: 21-0956
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patient Communication Self-Efficacy Score

  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.

  Baseline, 19 months, every 12-24 months up to 15 years

Secondary Outcomes (5)

• Tumor Recurrence Events

  9 months, 19 months, every 12-24 months up to 15 years

• Incidence of Second Primary Tumors

  9 months, 19 months, every 12-24 months up to 15 years

• Breast Cancer-Specific and All-Cause Mortality

  8 years and 15 years

• Quality of life measured using the Functional Assessment of Cancer Therapy - Breast (FACT-B)

  9 months, 19 months, every 12-24 months up to 15 years

• Quality of life measured using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  9 months, 19 months, every 12-24 months up to 15 years

Study Arms (1)

Newly diagnosed with breast cancer

EXPERIMENTAL

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

Behavioral: Structured behavioral intervention

Interventions

Structured behavioral intervention BEHAVIORAL

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.

Also known as: Structured behavioral intervention embedded within the research process

Newly diagnosed with breast cancer

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• women with ductal carcinoma in situ (DCIS)
• live outside of 59 counties of North Carolina

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Breast Cancer Research Foundation: collaborator
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms; Treatment Adherence and Compliance; Patient Participation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Health Behavior; Behavior; Patient Acceptance of Health Care

Central Study Contacts

Heather J Tipaldos

CONTACT

(919) 966-9438; heather_tipaldos@unc.edu

Melissa A Troester

CONTACT

(919) 966-9438; troester@email.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 9, 2025
• Study Start: November 28, 2023
• Primary Completion (Estimated): December 31, 2044
• Study Completion (Estimated): December 31, 2044
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)