- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02205853
Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.
An Evaluation of a Patient-directed Strategy Compared With a Multi-faceted Strategy to Implement Physical Cancer Rehabilitation Programmes; a Controlled Before and After Study.
연구 개요
상태
상세 설명
The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy.
We will conduct a clustered controlled before and after study (CBA) in the Netherlands that compares two strategies to implement PCRPs. The patient-directed (PD) strategy (five hospitals) will focus on change at the patient level. The multi-faceted (MF) strategy (five hospitals) will focus on change at the patient, professional and organizational levels. Eligibility criteria are as follows: (A) patients: adults; preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases. (B) Healthcare professionals: involved in cancer care.
A stepwise approach will be followed:
Step 1: Analysis of the current implementation of PCRPs and the examination of barriers and facilitators for implementation, via a qualitative study with patients (four focus groups n = 10-12) and their healthcare workers (four focus groups n = 10-12 and individual interviews n = 30-40) and collecting data on adherence to quality indicators (n = 500 patients, 50 per hospital).
Step 2: Selection and development of interventions to create a PD and MF strategy during expert's roundtable discussions, using the knowledge gained in step 1 and a literature search of the effect of strategies for implementing PCRPs.
Step 3: Test and compare both strategies with a clustered CBA (effectiveness, process evaluation and costs), by data extraction from existing registration systems, questionnaires and interviews. For the effectiveness and cost-effectiveness, n = 500 patients, 50 per hospital. For the process evaluation, n=50 patients, 5 per hospital, and n = 40 healthcare professionals, 4 per hospital.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Gelderland
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Nijmegen, Gelderland, 네덜란드, 6500HB
- 모병
- Radboud University Nijmegen Medical Center
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연락하다:
- C. IJsbrandy, drs.
- 이메일: charlotte.ijsbrandy@radboudumc.nl
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
patients:
- preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases.
- Adults
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Healthcare professionals:
• involved in cancer care in one of the participating hospitals
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: The patient-directed (PD) strategy
A single-faceted patient-directed (PD) strategy that will embed the change at patient level.
|
The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.
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다른: The multi-faceted (MF) strategy
A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels.
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The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
기간: baseline and at follow-up
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A pre- and post measurement of 'the percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'' will be done.
The differences between the pre- and post measurement will be measured.
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baseline and at follow-up
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The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.
기간: baseline and at follow-up
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A pre- and post measurement of 'The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'' will be done.
The differences between the pre- and post measurement will be measured.
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baseline and at follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Quality of life
기간: baseline and at follow-up
|
A pre- and post measurement of 'QoL' will be done.
The differences between the pre- and post measurement will be measured.
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baseline and at follow-up
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Patientempowerment
기간: baseline and at follow-up
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A pre- and post measurement of 'patientempowerment' will be done.
The differences between the pre- and post measurement will be measured.
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baseline and at follow-up
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Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.
기간: baseline and at follow-up
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A pre- and post measurement of ' the Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'' will be done.
The differences between the pre- and post measurement will be measured.
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baseline and at follow-up
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Process-evaluation
기간: at follow-up
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The experiences and exposure of patients and professionals with the PD- and MF strategy will be evaluated by interviews.
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at follow-up
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Cost
기간: at follow-up
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incremental costs and incremental cost-effectiveness ratios (ICERs)
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at follow-up
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공동 작업자 및 조사자
수사관
- 수석 연구원: C. IJsbrandy, MD, Radboud Univeristy Medical Centre Nijmegen
- 연구 의자: R.P.M.G. Hermens, PhD, Radboud Univeristy Medical Centre Nijmegen
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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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