Carolina Breast Cancer Study: Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes in the Carolina Breast Cancer Study, Phase 4
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,300
- 试验地点
- 2
- 主要终点
- Patient Communication Self-Efficacy Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with invasive breast cancer
- •live in 59 counties in North Carolina
排除标准
- •women with ductal carcinoma in situ (DCIS)
- •live outside of 59 counties of North Carolina
研究组 & 干预措施
Newly diagnosed with breast cancer
Participants with newly diagnosed with breast cancer live in 59 North Carolina counties.
干预措施: Structured behavioral intervention (Behavioral)
结局指标
主要结局
Patient Communication Self-Efficacy Score
时间窗: 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.
次要结局
- 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)