Behavioral Economics Study of Individual Factors Influencing Time-to-care Among Women With Invasive Breast Cancer in the Hauts-de-France Region
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 34
- 主要终点
- Total time from first warning sign to initiation of first treatment.
研究概览
简要总结
Women in the Hauts-de-France region show higher breast cancer mortality despite no overall higher incidence, suggesting differences in the care pathway. This multicenter study will describe the overall time from the first warning sign to initiation of the first treatment, and will break down this delay into three consecutive intervals (symptoms to mammography, mammography to biopsy, biopsy to first treatment). Participants will complete a one-time questionnaire (up to 1 hour, with assistance if needed), and clinical data will be extracted in a standardized way from medical records (key dates and tumor characteristics). A random sample of 10% of incident breast cancer cases identified by each hospital information department will be used to ensure balanced geographic representation across 38 centers. The study will also explore how individual and contextual factors (psychological, behavioral, socio-demographic, access to care, communication) are associated with each time interval, and exploratory analyses will assess links with severity (metastases and prognostic score).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age ≥ 18 years.
- •Confirmed invasive breast carcinoma.
- •Diagnosis in 2024 (and/or < 12 months at inclusion depending on center organization).
- •Affiliated with the French social security system.
- •Resident of Hauts-de-France since diagnosis.
- •Information provided and non-opposition documented (MR-003).
排除标准
- •Male breast cancer.
- •Other histologies (phyllodes tumor, sarcoma, lymphoma).
- •Pure ductal carcinoma in situ (in situ only).
- •Personal history of breast cancer (including in situ).
- •Non-French-speaking.
- •Person deprived of liberty.
结局指标
主要结局
Total time from first warning sign to initiation of first treatment.
时间窗: One-time assessment using patient-reported dates and medical record dates at inclusion (single questionnaire session + record extraction). Questionnaire time : around 1 hour
次要结局
- Time from first warning sign to first mammography(At inclusion, one-time assessment using patient-reported dates and medical record dates.)
- Time from mammography to biopsy.(At inclusion, one-time assessment using patient-reported dates and medical record dates.)
- Time from biopsy to initiation of first treatment.(At inclusion, one-time assessment using patient-reported dates and medical record dates.)
- To evaluate breast cancer severity at diagnostic. Severity will be assessed by the presence of metastatic disease at diagnosis, recorded as a binary outcome (yes/no) indicating the rate of metastatic at diagnosis(At inclusion, assessed from medical record extraction.)
- To evaluate patients with localized breast cancer, by pronosis estimated using the PREDIC Breast tool.(At inclusion, calculated using clinical variables extracted from the medical record)