Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 617
- 试验地点
- 9
- 主要终点
- Overall cost measurements of the different care pathways.
研究概览
简要总结
This prospective, multicenter, observational study aims to explore a comprehensive approach to the care of early breast cancer patients in a regional health territory (including 1.5 million women and characterized by a breast cancer incidence and mortality higher than national ranges), incorporating all healthcare actors inside and outside the hospital.
详细描述
The treatment course of a breast cancer patient includes a hospital stay, home health care that requires outpatient services, supportive care and a follow-up course. Outpatient surgery and home hospitalization units are two innovative organizational technologies that are strongly recommended because of their putative positive medico-economic impact; however, these structures are poorly studied in terms of quality of care and patient satisfaction. Regional implementation of these innovations is heterogeneous, thus allowing a comparative study.
This prospective, multicenter, observational study aims to explore a comprehensive approach to the care of early breast cancer patients in a regional health territory (including 1.5 million women and characterized by a breast cancer incidence and mortality higher than national ranges), incorporating all healthcare actors inside and outside the hospital.
This study will be conducted in academic centers, general hospitals and private centers. In the different participating centers, the implemented care steps are different and may include outpatient surgery, home hospitalization, a one-stop breast clinic visit, care by an oncology pivot nurse and/or screening for supportive care. Outpatient surgery and home hospitalization in particular are two health technologies that are validated by the French National Authority for Health but used differently in different centers.
The primary objective is to examine the economic and financial measurements of the different care pathways of early breast cancer patients to compare the economic burden of outpatient surgery and home hospitalization with the conventional care pathway.
The secondary objectives are:
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
- 否
入选标准
- •Signed written informed consent.
- •Patients aged ≥18 years.
- •Previously untreated, operable breast cancer
- •Affiliation with the social security system (or a similar coverage)
- •Patient living in one of these french department : "Hauts-de-Seine (92)", "les Yvelines (78)", or "le Val d'Oise (95)".
- •Female gender.
排除标准
- •Previous history of breast cancer.
- •Metastatic, locally advanced, or inflammatory breast cancer, as defined by the AJCC (American Joint Committee on Cancer, 7th Edition).
- •Any prior treatment for primary breast cancer.
- •Patient with any psychological, sociological or geographical condition potentially hampering compliance with the study follow-up schedule.
结局指标
主要结局
Overall cost measurements of the different care pathways.
时间窗: Up to one year after patient registration
Evaluating the overall costs of the pathway care (health care and supportive care consumption) at one year for the different perspectives.
Overall cost measurements of the different care pathways for the patient
时间窗: Up to one year after patient registration
Evaluating the out-of-pocket health expenses for breast cancer during the first year post diagnosis (direct and indirect costs).
Care pathways description of early breast cancer patients.
时间窗: Up to one year after patient registration
Care pathways will be characterized by the sequence of different care steps. Care steps may include : outpatient surgery, home hospitalization, a one-stop breast clinic visit, care by an oncology pivot nurse and/or screening for supportive care.
Overall cost measurements of the different care pathways for health insurance
时间窗: Up to one year after patient registration
Evaluating the indirect costs of health insurance
次要结局
- Patient satisfaction evaluation(Up to one year after patient registration.)
- Structures and organizations interactions description(Up to one year after patient registration)
- Supportive care needs assessement(Up to one year after patient registration)
- Breast cancer impact on patient's professional activity(Up to one year after patient registration.)