Optimizing the Care Pathways of Patients Treated for Operable Breast. (OPTIsoins01)
Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
研究概览
详细说明
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:
Assessing patient satisfaction and needs for supportive care. Evaluating the structures and organizations. Evaluating the tool exchanges between the actors over the treatment course.
All parameters related to the patient and to disease characteristics, determinants and management characteristics within and outside the center within one year will be collected and centralized in the study database. The patients' course of care will be divided into five stages: preadmission, hospitalization, the postoperative period (+ 1 month), adjuvant treatments and one-year follow-up. Care pathways will be identified, described and analyzed to meet the primary objective and the secondary objectives.
After analyzing these care pathways, we will propose solutions for optimizing hospital and nonhospital care, thereby building efficient connections among the hospital, home health care, district nurse networks, medical and social sectors, and occupational reintegration.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Argenteuil、法国、95100
- Victor Dupouy Hospital
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Clamart、法国
- Antoine Béclère Hospital
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Colombes、法国、92700
- Louis Mourier Hospital
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Le Chesnay、法国、78150
- André Mignot Hospital - Versailles
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Paris、法国、75005
- Institut Curie
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Paris、法国、75018
- Bichat Beaujon University Hospital
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Poissy、法国、78300
- Poissy Interegional Hospital Center
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Pontoise、法国、95000
- Rene Dubos Hospital
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Saint-Cloud、法国、92210
- Institut Curie - René Huguenin Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Care pathways description of early breast cancer patients.
大体时间：Up to one year after patient registration
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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.
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Up to one year after patient registration
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Overall cost measurements of the different care pathways.
大体时间：Up to one year after patient registration
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Evaluating the overall costs of the pathway care (health care and supportive care consumption) at one year for the different perspectives.
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Up to one year after patient registration
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Overall cost measurements of the different care pathways for health insurance
大体时间：Up to one year after patient registration
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Evaluating the indirect costs of health insurance
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Up to one year after patient registration
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Overall cost measurements of the different care pathways for the patient
大体时间：Up to one year after patient registration
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Evaluating the out-of-pocket health expenses for breast cancer during the first year post diagnosis (direct and indirect costs).
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Up to one year after patient registration
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient satisfaction evaluation
大体时间：Up to one year after patient registration.
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Patient satisfaction will be assessed at different time points using the OUT-PATSAT35 questionnaire validated in French.
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Up to one year after patient registration.
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Supportive care needs assessement
大体时间：Up to one year after patient registration
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The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey - Breast Cancer module (SCNS-BR8) validated in French.
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Up to one year after patient registration
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Supportive care needs assessement
大体时间：Up to one year after patient registration
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The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey Short Form (SCNS-SF34) validated in French.
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Up to one year after patient registration
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Breast cancer impact on patient's professional activity
大体时间：Up to one year after patient registration.
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Evaluating patient return to work : Existence of an occupational reintegration or not.
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Up to one year after patient registration.
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Breast cancer impact on patient's professional activity
大体时间：Up to one year after patient registration.
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Evaluating patient return to work : Date of return to work
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Up to one year after patient registration.
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Breast cancer impact on patient's professional activity
大体时间：Up to one year after patient registration.
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Evaluating patient return to work : Organization of working time description
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Up to one year after patient registration.
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Breast cancer impact on patient's professional activity
大体时间：Up to one year after patient registration.
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Evaluating patient return to work : Number of days out of work
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Up to one year after patient registration.
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Structures and organizations interactions description
大体时间：Up to one year after patient registration
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Identification of health care actors inside and outside the hospital
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Up to one year after patient registration
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Structures and organizations interactions description
大体时间：Up to one year after patient registration
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identification of the interactions between the organizations (e.g., identification, shared tools, resource sharing and nurse training).
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Up to one year after patient registration
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Structures and organizations interactions description
大体时间：Up to one year after patient registration
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Regular practitioners questionnaires
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Up to one year after patient registration
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Care pathways suggestion for a regional health territory.
大体时间：Through study completion (within one year after the last patient follow-up)
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After analyzing these care pathways, we will propose solutions for optimizing hospital and nonhospital care, thereby building efficient connections among the hospital, home health care, district nurse networks, medical and social sectors, and occupational reintegration.
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Through study completion (within one year after the last patient follow-up)
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合作者和调查者
调查人员
- 研究主任：Roman ROUZIER, Pr、Institut Curie
- 研究主任：Delphine HEQUET, MD PhD、Institut Curie
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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