Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Cancer, Fatigue

Intervention / Treatment
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* Other: The patient-directed (PD) strategy
* Other: The multi-faceted (MF) strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The patient-directed (PD) strategy<br>A single-faceted patient-directed (PD) strategy that will embed the change at patient level. | Other: The patient-directed (PD) strategy<br>* The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.<br>|
| Other: The multi-faceted (MF) strategy<br>A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels. | Other: The multi-faceted (MF) strategy<br>* The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'. | 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 | 
| The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | 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 | 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'. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncology Service Hospital, Patient-centred, Exercise, Neoplasms, Rehabilitation, Qualitative Research, Health Plan Implementation, Quality of Health Care, Guidelines, Quality of Life