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

Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02205853
• Other study ID #: NKI 2010-4854
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2014
• Last updated: September 4, 2015

Study information

• Verified date: August 2015
• Source: Radboud University
• Contact: C. IJsbrandy, MD
• Phone: +31 (0)24 3615305
• Email: charlotte.ijsbrandy[@]radboudumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Fatigue

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process-evaluation	The experiences and exposure of patients and professionals with the PD- and MF strategy will be evaluated by interviews.	at follow-up	No
Other	Cost	incremental costs and incremental cost-effectiveness ratios (ICERs)	at follow-up	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No