Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

• ClinicalTrials.gov Identifier: NCT02221986
• Recruitment Status: Completed
• First Posted: August 21, 2014
• Last Update Posted: April 5, 2018
• Sponsor: Odense University Hospital
• Collaborator: University of Southern Denmark
• Information provided by (Responsible Party): Anders Hansen, Odense University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neoplasms; CNS Neoplasms	Behavioral: Interdisciplinary rehabilitation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment
• Actual Study Start Date: February 1, 2015
• Actual Primary Completion Date: February 14, 2018
• Actual Study Completion Date: February 14, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Health related quality of life [ Time Frame: Change from Baseline HRQoL at 6 months ]
   Questionnaires EORTC-QLQ-30 & BN-20

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Denmark

Odense University Hospital

Odense, Funen, Denmark, 5000

Sponsors and Collaborators

Odense University Hospital

University of Southern Denmark

Investigators

• Study Chair: Karen Søgaard, Professor; University of Southern Denmark

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hansen A, Pedersen CB, Jarden JO, Beier D, Minet LR, Søgaard 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, Søgaard 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, Søgaard 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.

• Responsible Party: Anders Hansen, Physiotherapist, Master of Health Science, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT02221986
• Other Study ID Numbers: S-20140108
• First Posted: August 21, 2014
• Last Update Posted: April 5, 2018
• Last Verified: September 2017

Keywords provided by Anders Hansen, Odense University Hospital:

Interdisciplinary rehabilitation; Neurooncology; Physiotherapy; Occupational therapy; Neurorehabilitation; Glioma

Additional relevant MeSH terms:

Neoplasms; Glioma; Central Nervous System Neoplasms; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases