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

R

Radboud University Medical Center

Status

Unknown

Conditions

Cancer
Fatigue

Treatments

Other: The multi-faceted (MF) strategy
Other: The patient-directed (PD) strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT02205853
NKI 2010-4854

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

10 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

R.P.M.G. Hermens, PhD; C. IJsbrandy, MD

Data sourced from clinicaltrials.gov

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