Clinical trial NCT02221986: Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment
Official title: Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
CNS Neoplasms
Keywords: Interdisciplinary rehabilitation
Neurooncology
Physiotherapy
Occupational therapy
Neurorehabilitation
Glioma
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2014-08-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Health related quality of life
timeFrame: Change from Baseline HRQoL at 6 months
Secondary outcomes:
measure: Symptom burden
timeFrame: Change from Baseline Symptom burden at 6 months
measure: Physical activity levels
timeFrame: Change from Baseline Physical activity levels at 6 months
measure: Muscle strength
timeFrame: Change from Baseline Musclestrength at 3 months
measure: VO2peak
timeFrame: Change from Baseline VO2peak at 3 months
measure: Balance
timeFrame: Change from Baseline Balance at 3 months
measure: Gait function
timeFrame: Change from Baseline gait function at 3 months
measure: Activity levels
timeFrame: Change from Baseline Activity levels at 3 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Funen
Study officials:
affiliation: University of Southern Denmark
name: Karen Søgaard, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.