Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

Study Overview
=================
Brief Summary
-----------------
The results of the present RCT study will add to the growing body of literature investigating the potential role of exercise as a supportive therapeutic intervention for patient with glioma.

Detailed Description
-----------------
Gliomas are the most frequent primary neoplasm in the CNS and according to the World Health Organization histologically categorized into low-grade glioma (LGG) (WHO grades I/II) or high-grade glioma (HGG) (WHO grades III/IV). Gliomas are among the biggest challenges within the field of neuro-rehabilitation and oncology, and optimising treatment by improving QoL, function and cognition is of major clinical importance in this population. Because the majority of patients cannot be cured, clinical cancer research traditionally have focused on prolonging survival, exposing relapse or optimising the response to the medical treatment. Today there is a general consensus that health-related quality of life (HRQoL) is important in the evaluation of new treatments. However, research in HRQoL among patients with gliomas is scarce compared to the other categories of patients with tumors. In recent years have exercise become an important part of cancer treatment. The effects is well documented in studies among other cancer patients than gliomas and includes improvements of quality of life, physical function, reduce fatigue and thereby supports daily activities among cancer patients'. Inpatient rehabilitation studies among glioma patients have also indicated improved HRQoL and functional measurements such as activity of daily life, mobility and cognition. Despite of this rehabilitation efforts is still not emphasized in this population and recent literature concludes that there are no well-designed clinical studies examining the effect of multidisciplinary rehabilitation among Glioma patients. This study is the first to investigate the effect of an intensive specialised interdisciplinary outpatient rehabilitation program among gliomas patients.

Official Title
-----------------
Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

Conditions
-----------------
Neoplasms, CNS Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Interdisciplinary rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary glioma (WHO grades I-IV) Age ≥ 18 Reference with diagnosis or treatment at Odense University Hospital Karnofsky performance score (KPS) ≥70 Ability to understand Danish. Exclusion Criteria: Pregnancy Known psychiatric diagnosis or substance abuse Heart problems excluding intense exercise (NYHA group III and IV) Pronounced impressive/expressive aphasia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interdisciplinary rehabilitation<br>The intervention consists of 6 weeks intensive outpatient physiotherapy in conjunction with 0-6 weeks of occupational therapy if need is indicated. The physical intervention contains supervised group exercise of 90 minutes three times a week in groups up to four patients included continuously. The occupational therapy intervention consists of individual training 60 minutes twice a week for patients having deficits in activity or participation levels measured by the Assessment of Motor and Process Skills (AMPS). | Behavioral: Interdisciplinary rehabilitation<br> <br> |
| No Intervention: Care as usual<br>The control group receives usual standard of care (e.g. no training, individual training or group training in the municipality). The amount of training in this group is based on a questionnaire at the follow-up trials. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | Questionnaires EORTC-QLQ-30 & BN-20 | Change from Baseline HRQoL at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom burden | Assessed through EORTC-QLQ-30 & BN-20 | Change from Baseline Symptom burden at 6 months | 
| Physical activity levels | Physical activity at work and leisure time ( Assessed through questionnaire by Saltin and Grimsby 1968 and Physical Activity Scale) | Change from Baseline Physical activity levels at 6 months | 
| Muscle strength | Assessed through 3-8 submax repetition maximum | Change from Baseline Musclestrength at 3 months | 
| VO2peak | Assessed through Åstrand 1-pkt. cycle test. | Change from Baseline VO2peak at 3 months | 
| Balance | Assessed through wii balance board | Change from Baseline Balance at 3 months | 
| Gait function | Assessed through 10 meter walk test. Time and step frequency. | Change from Baseline gait function at 3 months | 
| Activity levels | Assessed through questionnaire (Impact on Participation and Autonomy) | Change from Baseline Activity levels at 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiotherapy, Occupational therapy, Neurorehabilitation, Glioma, Interdisciplinary rehabilitation, Neurooncology