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.

Abstract

MAIN OUTCOME MEASURES

% screened patients, % referrals to PCRPs, incremental costs and incremental cost-effectiveness ratios (ICERs).

METHODS/DESIGN

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 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.

TRAIL REGISTRATION

NCT02205853 (ClinicalTrials.gov).

BACKGROUND

The need for physical cancer rehabilitation programmes (PCRPs), addressing adverse effects from cancer, is growing. Implementing these programmes into daily practice is still a challenge. Since barriers for successful implementation often arise at different levels in healthcare, multi-faceted strategies focusing on multiple levels are likely more effective than single-faceted strategies. Nevertheless, most studies implementing PCRPs used strategies directed at patients only. 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.