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

September 4, 2015 updated by: Rosella Hermens, Radboud University Medical Center

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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'.
Time Frame: 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
The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 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
Time Frame: 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'.
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Process-evaluation
Time Frame: at follow-up
The experiences and exposure of patients and professionals with the PD- and MF strategy will be evaluated by interviews.
at follow-up
Cost
Time Frame: at follow-up
incremental costs and incremental cost-effectiveness ratios (ICERs)
at follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: C. IJsbrandy, MD, Radboud Univeristy Medical Centre Nijmegen
  • Study Chair: R.P.M.G. Hermens, PhD, Radboud Univeristy Medical Centre Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKI 2010-4854

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on The patient-directed (PD) strategy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe