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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Gelderland
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Nijmegen, Gelderland, Nederland, 6500HB
- Werving
- Radboud University Nijmegen Medical Center
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Contact:
- C. IJsbrandy, drs.
- E-mail: charlotte.ijsbrandy@radboudumc.nl
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: 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.
|
|
Ander: The multi-faceted (MF) strategy
A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels.
|
The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
Tijdsspanne: baseline and at follow-up
|
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.
|
baseline and at follow-up
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The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.
Tijdsspanne: baseline and at follow-up
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Quality of life
Tijdsspanne: 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.
|
baseline and at follow-up
|
|
Patientempowerment
Tijdsspanne: 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.
|
baseline and at follow-up
|
|
Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.
Tijdsspanne: baseline and at follow-up
|
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.
|
baseline and at follow-up
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Process-evaluation
Tijdsspanne: at follow-up
|
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
Tijdsspanne: at follow-up
|
incremental costs and incremental cost-effectiveness ratios (ICERs)
|
at follow-up
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: C. IJsbrandy, MD, Radboud Univeristy Medical Centre Nijmegen
- Studie stoel: R.P.M.G. Hermens, PhD, Radboud Univeristy Medical Centre Nijmegen
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Primaire voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NKI 2010-4854
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