Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.
Primary Purpose
Cancer, Fatigue
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
The patient-directed (PD) strategy
The multi-faceted (MF) strategy
Sponsored by
About this trial
This is an interventional health services research trial for Cancer focused on measuring Oncology Service Hospital, Patient-centred, Exercise, Neoplasms, Rehabilitation, Qualitative Research, Health Plan Implementation, Quality of Health Care, Guidelines, Quality of Life
Eligibility Criteria
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
Sites / Locations
- Radboud University Nijmegen Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
The patient-directed (PD) strategy
The multi-faceted (MF) strategy
Arm Description
A single-faceted patient-directed (PD) strategy that will embed the change at patient level.
A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Quality of life
A pre- and post measurement of 'QoL' will be done. The differences between the pre- and post measurement will be measured.
Patientempowerment
A pre- and post measurement of 'patientempowerment' will be done. The differences between the pre- and post measurement will be measured.
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.
Full Information
NCT ID
NCT02205853
First Posted
July 21, 2014
Last Updated
September 4, 2015
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02205853
Brief Title
Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Fatigue
Keywords
Oncology Service Hospital, Patient-centred, Exercise, Neoplasms, Rehabilitation, Qualitative Research, Health Plan Implementation, Quality of Health Care, Guidelines, Quality of Life
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The patient-directed (PD) strategy
Arm Type
Other
Arm Description
A single-faceted patient-directed (PD) strategy that will embed the change at patient level.
Arm Title
The multi-faceted (MF) strategy
Arm Type
Other
Arm Description
A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels.
Intervention Type
Other
Intervention Name(s)
The patient-directed (PD) strategy
Intervention Description
The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.
Intervention Type
Other
Intervention Name(s)
The multi-faceted (MF) strategy
Intervention Description
The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.
Primary Outcome Measure Information:
Title
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
Description
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.
Time Frame
baseline and at follow-up
Title
The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.
Description
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.
Time Frame
baseline and at follow-up
Secondary Outcome Measure Information:
Title
Quality of life
Description
A pre- and post measurement of 'QoL' will be done. The differences between the pre- and post measurement will be measured.
Time Frame
baseline and at follow-up
Title
Patientempowerment
Description
A pre- and post measurement of 'patientempowerment' will be done. The differences between the pre- and post measurement will be measured.
Time Frame
baseline and at follow-up
Title
Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.
Description
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.
Time Frame
baseline and at follow-up
Other Pre-specified Outcome Measures:
Title
Process-evaluation
Description
The experiences and exposure of patients and professionals with the PD- and MF strategy will be evaluated by interviews.
Time Frame
at follow-up
Title
Cost
Description
incremental costs and incremental cost-effectiveness ratios (ICERs)
Time Frame
at follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
C. IJsbrandy, MD
Phone
+31 (0)24 3615305
Email
charlotte.ijsbrandy@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
R.P.M.G. Hermens, PhD
Phone
+31 (0)24 3615305
Email
Rosella.hermens@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. IJsbrandy, MD
Organizational Affiliation
Radboud Univeristy Medical Centre Nijmegen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R.P.M.G. Hermens, PhD
Organizational Affiliation
Radboud Univeristy Medical Centre Nijmegen
Official's Role
Study Chair
Facility Information:
Facility Name
Radboud University Nijmegen Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C. IJsbrandy, drs.
Email
charlotte.ijsbrandy@radboudumc.nl
12. IPD Sharing Statement
Citations:
PubMed Identifier
26345182
Citation
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.
Results Reference
derived
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Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.
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