Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; CNS Neoplasms
• Intervention / Treatment: Behavioral: Interdisciplinary rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Funen
    • Odense, Funen, Denmark, 5000
      • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interdisciplinary rehabilitation; 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
NO_INTERVENTION: Care as usual; 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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Southern Denmark
• Investigators: Study Chair: Karen Søgaard, Professor, University of Southern Denmark

Publications and helpful links

General Publications

• Hansen A, Pedersen CB, Jarden JO, Beier D, Minet LR, Sogaard K. Effectiveness of Physical Therapy- and Occupational Therapy-Based Rehabilitation in People Who Have Glioma and Are Undergoing Active Anticancer Treatment: Single-Blind, Randomized Controlled Trial. Phys Ther. 2020 Mar 10;100(3):564-574. doi: 10.1093/ptj/pzz180.
• Fahrenholtz ML, Hansen A, Sogaard K, Andersen LN. Finding 'the inner drive' for a rehabilitation process: a small-scale qualitative investigation among male patients with primary glioma. BMJ Open. 2019 Dec 8;9(12):e031665. doi: 10.1136/bmjopen-2019-031665.
• Hansen A, Rosenbek Minet LK, Sogaard K, Jarden JO. The effect of an interdisciplinary rehabilitation intervention comparing HRQoL, symptom burden and physical function among patients with primary glioma: an RCT study protocol. BMJ Open. 2014 Oct 3;4(10):e005490. doi: 10.1136/bmjopen-2014-005490.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2015
• Primary Completion (ACTUAL): February 14, 2018
• Study Completion (ACTUAL): February 14, 2018

Study Registration Dates

• First Submitted: August 19, 2014
• First Submitted That Met QC Criteria: August 20, 2014
• First Posted (ESTIMATE): August 21, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Glioma; Physiotherapy; Occupational therapy; Neurorehabilitation; Neurooncology; Interdisciplinary rehabilitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms; Glioma; Central Nervous System Neoplasms
• Other Study ID Numbers: S-20140108