The Journey of Women With Breast Cancer in Mozambique: What is the Best Path? A Prospective Cohort With Patient Navigation as an Intervention to Reduce Treatment Disparities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- time interval between first symptom and first medical consultation
研究概览
简要总结
The objective of this observational study is to introduce a patient navigation system within the breast cancer unit at Hospital Central de Maputo (MOZ) and gather data to assess the efficacy of patient navigation in enhancing oncological outcomes among this patient cohort. The primary inquiries it seeks to address are as follows:
- Can patient navigation reduce the duration (in days) between patient admission and the commencement of treatment?
- Does patient navigation influence overall survival rates when juxtaposed with historical cohorts from the local setting? Participants will receive continuous support from a patient navigator starting from admission until the initiation of any oncological treatment.
详细描述
-General Objective: To implement an oncological navigation platform for breast cancer patients receiving treatment at Maputo Central Hospital (HCM) over a proposed period of 12 months after project approval by the local IRB.
-Specific Objectives:
- Develop an oncological patient navigation system for breast cancer patients treated at HCM.
- Establish a prospective cohort of navigated breast cancer patients (with invasive or ductal carcinoma in situ) treated at HCM in 2024-25 (recruitment period of twelve months).
- Collect diverse epidemiological data from navigated patients during the proposed study period.
- Describe the following variables: time from first symptom until first medical consultation (in days), time from first medical consultation to cancer diagnosis (in days) and time from diagnosis to first treatment (either surgery or neoadjuvant treatment) in days.
- Compare time from first symptom to diagnosis (in days) and time from diagnosis to first treatment (in days) to a historical cohort published by Brandão M. et al (The Oncologist, 2021).
- Collect overall survival data in this cohort for thirty six months after last patient recruited for future publication.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years and older
- •will undergo breast cancer treatment at HCM
- •consent to participate
排除标准
- •less than18 years of age
- •history of other previous malignancies (including breast cancer)
- •history of breast cancer treatment initiated elsewhere
- •lack of consent to participate
结局指标
主要结局
time interval between first symptom and first medical consultation
时间窗: 12 months
time interval (in days) between first symptom and first medical consultation (either at Maputo Central Hospital or any other medical service)
time interval between first medical consultation and cancer diagnosis
时间窗: 12 months
time interval (in days) between first medical consultation (at Maputo Central Hospital) and cancer diagnosis (by any type of biopsy performed at Maputo Central Hospital)
time interval between cancer diagnosis and first treatment
时间窗: 12 months
time interval (in days) between cancer diagnosis (by any type of biopsy performed at Maputo Central Hospital) and first treatment (surgery or neoadjuvant chemotherapy at Maputo Central Hospital)
overall survival
时间窗: 36 months after last patient recruited
overall survival (in months) of navigated breast cancer patients
次要结局
未报告次要终点
研究者
Renato Cagnacci Neto
Principal Investigator
AC Camargo Cancer Center