Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents (CHIMORAL)
Evaluation of the Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents
調査の概要
状態
条件
詳細な説明
Introduction :
Oral antineoplastic agents know a full development in particular targeted therapies. Their adverse events (AE) lately detected can lead to non compliance or treatment discontinuation which can be at the origin of disease progression. They can also lead to hospitalization or recourse to emergency department associating to cost for the society.
Hypothesis :
A coordinated intervention of cancer network in relation with primary healthcare professionals, would improve safety of care's patient treated with oral antineoplastic agent by preventing serious AEs through rapid detection.
Primary objective :
The primary objective is to estimate the effect of coordinated intervention of cancer network, in terms of number of early or unforeseen recourses to hospital for AE, within the first 6 months after oral neoplastic agent introduction.
Secondary objectives :
The secondary objective is to estimate the effect of coordinated intervention of cancer network, within the first 6 months after oral neoplastic agent introduction, in terms of number of hospitalization for AE, number of consultation for AE, number of early or unforeseen recourses to hospital for grade 1 / 2 AE, number of AE per detection grade, AE maximal grade, AE all grade, disease progression, the global survival (death for any causes and for AE), drug dose-intensity taken by the patient during his treatment, number of recourses to the health care system, quality of life, patient's satisfaction, medical economic evaluation
Primary outcome :
The main outcome is the number of early or unforeseen recourses to hospital for AE.
Secondary outcomes :
The secondary outcomes are all deaths and deaths from AE, number of hospitalization for AE, number of consultation for AE, number of early or unforeseen recourses to hospital for grade 1 / 2 AE, disease progression, drug dose-intensity taken by the patient during his treatment, number of recourses to the health care system, number of AE per detection grade, AE maximal grade, AE all grade, quality of life, patient's satisfaction, medical economic evaluationMethodology, design :
A comparative, controlled, not randomized, multicenter, prospective, "quasi-experimental" study, allows estimating evolution of patients according to the existence of a cancer network in their residence place.
Number of needed subjects: 440 patients.
Total duration of the study: 27 months. Inclusion Period: 21 months. length of participation period for one patient: 6 months. Number of participating centers: 21. Average number of inclusions a month by center: 4.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
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Paris、フランス、75020
- Hôpital Tenon
-
-
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:
- patients affected by cancer (breast, colorectal, liver, lung, kidney, gastrointestinal stromal tumor, pancreas)
- treated by capecitabine, erlotinib, gefitinib, imatinib, lapatinib, sorafenib, sunitinib, vinorelbine, Evérolimus, Pazopanib, Etoposide, Topotécan
- 18 years old or more
Exclusion Criteria:
- refusal to participate
- lack proficiency in French ,
- having a Performance Status > 2,
- home based care,
- patient enrolled in clinical trials
- patient enrolled in therapeutic education program
- patient under administrative supervision or legal guardianship
- not affiliated with Patient Social Security or CMU (recipient or beneficiary)
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
コホートと介入
グループ/コホート |
|---|
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Group " coordinated care"
Patient living in place covered by cancer network participating to the study is in the group "coordinated care"
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Group " usual care "
Patient living in place covered by cancer network non participating to the study or without cancer network is in the group "usual care"
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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 |
時間枠 |
|---|---|
|
Number of early or unforeseen recourses to hospital for adverse event.
時間枠：within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
all deaths and deaths from AE
時間枠：within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
|
|
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number of hospitalization for AE
時間枠：within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
number of consultation for AE
時間枠：within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
number of early or unforeseen recourses to hospital for grade 1 / 2 AE
時間枠：within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
disease progression
時間枠：within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
drug dose-intensity taken by the patient during his treatment
時間枠：within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
number of recourses to the health care system
時間枠：within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
number of AE per detection grade, AE maximal grade, AE all grade
時間枠：within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
quality of life
時間枠：within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
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patient's satisfaction
時間枠：within the first 6 monts after oral neoplastic agent introduction
|
patient's satisfaction will be characterized with a questionnaire
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within the first 6 monts after oral neoplastic agent introduction
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medical economic evaluation
時間枠：within the first 6 monts after oral neoplastic agent introduction
|
Medical economic evaluation use The incremental cost-effectiveness ratio (ICER.
This is an equation used commonly in health economics to provide a practical approach to decision making regarding health interventions.
|
within the first 6 monts after oral neoplastic agent introduction
|
協力者と研究者
協力者
捜査官
- 主任研究者：Jean-¨Pierre Lotz, Professor、Assistance Publique - Hôpitaux de Paris
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
本研究に関する用語
その他の研究ID番号
- NI 12019
- C1204 (その他の識別子：ANSM)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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癌の臨床試験
-
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