Optimizing the Care Pathways of Patients Treated for Operable Breast. (OPTIsoins01)
Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Argenteuil、フランス、95100
- Victor Dupouy Hospital
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Clamart、フランス
- Antoine Béclère Hospital
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Colombes、フランス、92700
- Louis Mourier Hospital
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Le Chesnay、フランス、78150
- André Mignot Hospital - Versailles
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Paris、フランス、75005
- Institut Curie
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Paris、フランス、75018
- Bichat Beaujon University Hospital
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Poissy、フランス、78300
- Poissy Interegional Hospital Center
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Pontoise、フランス、95000
- Rene Dubos Hospital
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Saint-Cloud、フランス、92210
- Institut Curie - René Huguenin Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Care pathways description of early breast cancer patients.
時間枠：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.
時間枠：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.
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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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient satisfaction evaluation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to one year after patient registration
|
identification of the interactions between the organizations (e.g., identification, shared tools, resource sharing and nurse training).
|
Up to one year after patient registration
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Structures and organizations interactions description
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Care pathways suggestion for a regional health territory.
時間枠：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)
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Roman ROUZIER, Pr、Institut Curie
- スタディディレクター：Delphine HEQUET, MD PhD、Institut Curie
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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