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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02205853
Enrollment
10
Registered
2014-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2015-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERThe patient-directed (PD) strategy

The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.

OTHERThe 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.

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.baseline and at follow-upA 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-upA 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

MeasureTime frameDescription
Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.baseline and at follow-upA 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.
Patientempowermentbaseline and at follow-upA pre- and post measurement of 'patientempowerment' will be done. The differences between the pre- and post measurement will be measured.
Quality of lifebaseline and at follow-upA pre- and post measurement of 'QoL' will be done. The differences between the pre- and post measurement will be measured.

Other

MeasureTime frameDescription
Process-evaluationat follow-upThe experiences and exposure of patients and professionals with the PD- and MF strategy will be evaluated by interviews.
Costat follow-upincremental costs and incremental cost-effectiveness ratios (ICERs)

Countries

Netherlands

Contacts

Primary ContactC. IJsbrandy, MD
charlotte.ijsbrandy@radboudumc.nl+31 (0)24 3615305
Backup ContactR.P.M.G. Hermens, PhD
Rosella.hermens@radboudumc.nl+31 (0)24 3615305

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026