Clinical trial NCT02205853: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Fatigue
Keywords: Oncology Service Hospital
Patient-centred
Exercise
Neoplasms
Rehabilitation
Qualitative Research
Health Plan Implementation
Quality of Health Care
Guidelines
Quality of Life
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
timeFrame: baseline and at follow-up
measure: The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'.
timeFrame: baseline and at follow-up
Secondary outcomes:
measure: Quality of life
timeFrame: baseline and at follow-up
measure: Patientempowerment
timeFrame: baseline and at follow-up
measure: Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.
timeFrame: baseline and at follow-up
Other outcomes:
measure: Process-evaluation
timeFrame: at follow-up
measure: Cost
timeFrame: at follow-up
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
Study officials:
affiliation: Radboud Univeristy Medical Centre Nijmegen
name: C. IJsbrandy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud Univeristy Medical Centre Nijmegen
name: R.P.M.G. Hermens, PhD
role: STUDY_CHAIR
References:
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.