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

Not Applicable

• Conditions: Fatigue; Cancer
• Interventions: Other: The multi-faceted (MF) strategy; Other: The patient-directed (PD) strategy

• Registration Number: NCT02205853
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Status Verified: 2015-08
• Last Update Submitted: 2015-09-04
• Last Update Posted: 2015-09-07
• Primary Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The multi-faceted (MF) strategy	The multi-faceted (MF) strategy	A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels.
The patient-directed (PD) strategy	The patient-directed (PD) strategy	A single-faceted patient-directed (PD) strategy that will embed the change at patient level.

Primary Outcome Measures

Name	Time	Method
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.	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.
The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life	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.
Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.	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.
Patientempowerment	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.

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands