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Clinical Trials/NCT02205853
NCT02205853
Unknown
Not Applicable

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.

Radboud University Medical Center1 site in 1 country10 target enrollmentJuly 31, 2014
ConditionsCancerFatigue

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Radboud University Medical Center
Enrollment
10
Locations
1
Primary Endpoint
The percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'.
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 31, 2014
End Date
October 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rosella Hermens

Dr

Radboud University Medical Center

Eligibility Criteria

Inclusion Criteria

  • preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases.
  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Quality of life(baseline and at follow-up)
  • Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'.(baseline and at follow-up)
  • Patientempowerment(baseline and at follow-up)

Study Sites (1)

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