Short summary

This study is designed as a randomized trial and contains an intervention of a standardized rehabilitation program including 6 weeks of intensive physiotherapy in a group of up to 4 patients and 0-6 weeks of individual occupational therapy training, depending if a need is present. The training is situated in combination with the primary medical treatment. The results is expected to add to the growing body of literature examining the potential role of exercise and therapeutic treatment as a supportive therapeutic intervention for patients with cancer by improving patients' self-rated quality of life through, reducing adverse effects to the medical treatment and improving physical function.

Rationale

Gliomas are a common name for the most present types of brain tumors and are among the biggest challenges in treatment and rehabilitation of cancer patients due to serious complications to the disease and as a result of the medical treatment. Up to 80% of patients experience cognitive impairments and force reductions and up to 53% of patients has visual or perceptual impairments. These impairments can have a cumulative effect and reduce patients' health-related quality of life and functional capacity significantly. But not only damage to brain tissue, from the tumor itself result in impairments. Medical treatment can produce significant adverse effects including severe fatigue (disease-induced tiredness), headache, vomiting and insomnia which also affect patients' daily activity and quality of life negatively. Although inpatient rehabilitation in brain tumor patients results in functional and cognitive improvements, rehabilitation is still not common in this patient group. The literature lacks quality studies examining effects on health-related quality of life, physical function and reduction of adverse reactions to the medical treatment through outpatient multidisciplinary rehabilitation.

Implications:
The result of this study is considered to have major importance in brain tumor patients. Not only does the results contribute to the emerging literature investigating the potential role of specialized rehabilitation as a supportive therapeutic intervention for patient with cancer but also contributes to neurorehabilitation in a broader context. Ideally the results of this study will contribute to a systematic increase in brain tumor patients receiving therapeutic in- and outpatient rehabilitation efforts, and thus optimizing the combined treatment of brain tumor patients. We find it theoretical possible to increase patients HRQoL by increasing patients activity of daily living through relieving adverse effects from the medical treatment and improving patients physical function.

Description of the cohort

Administration lists from neurosurgical departments are daily screened for potential participants.

Patient eligibility for inclusion must comply with:

1. Diagnosis of primary glioma (WHO grades I-IV),
2. Age: 18 or older, reference with diagnosis or treatment at Odense University Hospital
3. Karnofsky performances score (KPS) over or equal to 70
4. Ability to understand Danish.

Exclusion criteria are:

1. Pregnancy
2. Known psychiatric diagnosis or substance abuse
3. Heart problems excluding intense exercise (New York Heart Association (NYHA) group III and IV)
4. Pronounced impressive or expressive aphasia.

The reason for excluding KPS <70 is to ensure inclusion of patients able to conduct the physical training at an active and independent level, having cognitive ability to complete questionnaires and socially be able to interact with others.
Among high grade gliomas the intervention commences simultaneously with the radiation treatment approximately 4 weeks post discharge. Within patients with low grade gliomas, not offered radiation treatment, the intervention is likewise set to begin 4 weeks post discharge.

Data and biological material

All outcome measures are gathered at baseline (FU-0) at the end of the intervention (FU-1), at a 12-week follow-up (FU-2) and at a 6-month follow-up (FU-3: questionnaires only). At baseline, descriptive variables for each participant in terms of gender, age, weight, height and cohabiting is assessed.

Disease variables and treatments are obtained through review of medical records. Extent of resection is assessed through imaging definitions 72 h postoperative. Data on tumor structures, residual tumor, infarct or hematoma in or around the cavity and tumor localization are extracted.

Data is assessed through a test battery including questionnaires and physical assessments.
Questionnaires include: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) and the EORTC brain cancer module (EORTC QLQ-BN20), Impact on participation and autonomy Physical Activity Scale and EuroQol (EQ5-d).
Five physiological tests measure physical function defined as: estimated maximum muscle strength (knee extension, knee flexion, arm flexion, arm extension and leg press), maximal oxygen uptake (VO2peak), balance (sway test), gait velocity and steps frequency (10MWT).

Collaborating researchers and departments

Department of Rehabilitation Odense University Hospital

• PhD-student Anders Hansen
• Lisbeth Rosenbek Minet, MHS, PhD

Department of Neurology, Odense Univeristy Hospital

• Principal Supervisor and Professor Karen Søgaard, PhD
• Specialist Chief in Neurology Dagmar Beier

Department of Neurology, Herlev University Hospital

• Specialist Chief in Neurology Jens Ole Jarden

Publications associated with the project

The effect of an interdisciplinary rehabilitation intervention comparing HRQoL, symptom burden and physical function among patients with primary glioma: an RCT study protocol. / Hansen A, Rosenbek Minet LK, Søgaard K, et al. BMJ Open 2014;4:e005490.doi:10.1136/bmjopen-2014-005490