- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Gelderland
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Nijmegen, Gelderland, Pays-Bas, 6500HB
- Recrutement
- Radboud University Nijmegen Medical Center
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Contact:
- C. IJsbrandy, drs.
- E-mail: charlotte.ijsbrandy@radboudumc.nl
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: The patient-directed (PD) strategy
A single-faceted patient-directed (PD) strategy that will embed the change at patient level.
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The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.
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Autre: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
Délai: 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'.
Délai: 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.
|
baseline and at follow-up
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quality of life
Délai: 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
Délai: baseline and at follow-up
|
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'.
Délai: 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
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Process-evaluation
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: C. IJsbrandy, MD, Radboud Univeristy Medical Centre Nijmegen
- Chaise d'étude: R.P.M.G. Hermens, PhD, Radboud Univeristy Medical Centre Nijmegen
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NKI 2010-4854
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