- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01947296
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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Paris, 프랑스, 75020
- Hopital Tenon
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Number of early or unforeseen recourses to hospital for adverse event.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
all deaths and deaths from AE
기간: 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
기간: 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
기간: 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
기간: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
disease progression
기간: 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
기간: 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
기간: 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
기간: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
quality of life
기간: 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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patient's satisfaction
기간: within the first 6 monts after oral neoplastic agent introduction
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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
기간: within the first 6 monts after oral neoplastic agent introduction
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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.
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within the first 6 monts after oral neoplastic agent introduction
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Jean-¨Pierre Lotz, Professor, Assistance Publique - Hôpitaux de Paris
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NI 12019
- C1204 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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