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

Not Applicable

Recruiting

• Conditions: Breast Cancer; Breast Neoplasms

• Registration Number: NCT07214610
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Detailed Description

Study Population will be 3300 participants with invasive breast cancer among women aged 20-74 in 59 North Carolina counties between will be enrolled. Approximately 1,500 Black women (750 aged \<50 and 750 aged ≥50) and 1,750 non-Black women, including approximately 200 who self-identify as American Indian/Alaska Native (875 \<50, 875 ≥50) will be included.

Participants will complete a structured, in-person baseline interview covering breast cancer risk factors, quality of life, comorbidities, initial treatment, follow-up surveys will assess changes in self advocacy. Blood and/or saliva samples will be collected. Participants will provide consent for medical record abstraction and retrieval of tumor blocks.

Study Timeline

• Study Start: 2023-11-28
• Status Verified: 2025-10
• Study First Submitted: 2025-10-08
• Study First Submitted QC: 2025-10-08
• Last Update Submitted: 2025-10-08
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-10
• Primary Completion: 2044-12-31
• Study Completion: 2044-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3300

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient Communication Self-Efficacy Score	Baseline, 19 months, every 12-24 months up to 15 years	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.

Secondary Outcome Measures

Name	Time	Method
Tumor Recurrence Events	9 months, 19 months, every 12-24 months up to 15 years	Tumor recurrence will be identified via electronic medical records based on clinical documentation of local, regional, or distant recurrence of the primary cancer. The date and location of recurrence will be recorded using standardized clinical criteria.
Incidence of Second Primary Tumors	9 months, 19 months, every 12-24 months up to 15 years	Second primary tumors will be identified through electronic medical records and pathology reports. Criteria for classification as a second primary cancer and date of diagnosis will follow standard oncology definitions, distinct from recurrence of the original tumor.
Breast Cancer-Specific and All-Cause Mortality	8 years and 15 years	Mortality data, including breast cancer-specific and all-cause mortality, will be collected from electronic medical records and/or linked national death registries. Information will include vital status, cause of death, and date of death.; Time Frame:
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 will be assessed using the Breast (FACT-B) which is a validated, patient-reported outcome measure designed to assess quality of life in individuals with breast cancer. It combines the general FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire with a breast cancer-specific subscale. The tool evaluates five domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific to breast cancer. The FACT-B consists of 37 items, combining the 27-item FACT-G (general quality of life) and a 10-item Breast Cancer Subscale (BCS). Each item is rated on a 5-point Likert scale from 0 (not at all) to 4 (very much). Higher scores indicate better quality of life.
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	Quality of life will be assessed using the EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States