The effect of an interdisciplinary rehabilitation intervention comparing HRQoL, symptom burden and physical function among patients with primary glioma: an RCT study protocol.

INTRODUCTION

Gliomas are among the biggest challenges in neurological and oncology rehabilitation and optimising treatment is of major clinical importance in this population. Although inpatient rehabilitation among glioma patients' results in improved functional measures, rehabilitation efforts are still not emphasised in this patient group and the literature lacks studies investigating the impact of outpatient rehabilitation.

METHOD

This protocol describes a randomised 6-week parallel group rehabilitation study investigating an outpatient interdisciplinary rehabilitation programme. The intervention consists of 6 weeks intensive physiotherapy as groups exercise in conjunction with 0-6 weeks of individual occupational therapy if a need is present. The aim of this study is to describe the design of the upcoming randomised control trial (RCT). The results of the RCT will add to the growing body of literature investigating the potential role of exercise as a supportive therapeutic intervention for a patient with cancer.

ETHICS AND DISSEMINATION

The project is approved by the Regional Scientific Ethical Committees for Southern Denmark under Project-ID: (S-20140108) and by the Danish Data Protection Agency (J. no.2008-58-0035). Dissemination will occur through presentation and findings will be published in peer-reviewed journals. The key strength of this study is its randomised design and it is the first study to investigate a standardised outpatient interdisciplinary rehabilitation programme among patients with glioma. A potential limitation is the uncertainty and risk of side effects to the concomitant treatment, which enhances the risk of dropout.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov Identifier NCT02221986.