Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.
NCT ID: NCT02205853
Last Updated: 2015-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
Study Groups
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The patient-directed (PD) strategy
A single-faceted patient-directed (PD) strategy that will embed the change at patient level.
The patient-directed (PD) strategy
The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.
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 (MF) strategy
The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.
Interventions
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The patient-directed (PD) strategy
The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.
The multi-faceted (MF) strategy
The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Rosella Hermens
Dr
Principal Investigators
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C. IJsbrandy, MD
Role: PRINCIPAL_INVESTIGATOR
Radboud Univeristy Medical Centre Nijmegen
R.P.M.G. Hermens, PhD
Role: STUDY_CHAIR
Radboud Univeristy Medical Centre Nijmegen
Locations
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Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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IJsbrandy C, Ottevanger PB, Groen WG, Gerritsen WR, van Harten WH, Hermens RP. Study protocol: an evaluation of the effectiveness, experiences and costs of a patient-directed strategy compared with a multi-faceted strategy to implement physical cancer rehabilitation programmes for cancer survivors in a European healthcare system; a controlled before and after study. Implement Sci. 2015 Sep 7;10:128. doi: 10.1186/s13012-015-0312-3.
Other Identifiers
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NKI 2010-4854
Identifier Type: -
Identifier Source: org_study_id
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