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Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

Primary Purpose

Neoplasms, CNS Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Interdisciplinary rehabilitation
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Interdisciplinary rehabilitation, Neurooncology, Physiotherapy, Occupational therapy, Neurorehabilitation, Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interdisciplinary rehabilitation

Care as usual

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Health related quality of life
Questionnaires EORTC-QLQ-30 & BN-20

Secondary Outcome Measures

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

Full Information

First Posted
August 19, 2014
Last Updated
April 3, 2018
Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02221986
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
February 14, 2018 (Actual)
Study Completion Date
February 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, CNS Neoplasms
Keywords
Interdisciplinary rehabilitation, Neurooncology, Physiotherapy, Occupational therapy, Neurorehabilitation, Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interdisciplinary rehabilitation
Arm Type
Experimental
Arm Description
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).
Arm Title
Care as usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interdisciplinary rehabilitation
Primary Outcome Measure Information:
Title
Health related quality of life
Description
Questionnaires EORTC-QLQ-30 & BN-20
Time Frame
Change from Baseline HRQoL at 6 months
Secondary Outcome Measure Information:
Title
Symptom burden
Description
Assessed through EORTC-QLQ-30 & BN-20
Time Frame
Change from Baseline Symptom burden at 6 months
Title
Physical activity levels
Description
Physical activity at work and leisure time ( Assessed through questionnaire by Saltin and Grimsby 1968 and Physical Activity Scale)
Time Frame
Change from Baseline Physical activity levels at 6 months
Title
Muscle strength
Description
Assessed through 3-8 submax repetition maximum
Time Frame
Change from Baseline Musclestrength at 3 months
Title
VO2peak
Description
Assessed through Åstrand 1-pkt. cycle test.
Time Frame
Change from Baseline VO2peak at 3 months
Title
Balance
Description
Assessed through wii balance board
Time Frame
Change from Baseline Balance at 3 months
Title
Gait function
Description
Assessed through 10 meter walk test. Time and step frequency.
Time Frame
Change from Baseline gait function at 3 months
Title
Activity levels
Description
Assessed through questionnaire (Impact on Participation and Autonomy)
Time Frame
Change from Baseline Activity levels at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Søgaard, Professor
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
32043148
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.
Results Reference
derived
PubMed Identifier
31818840
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.
Results Reference
derived
PubMed Identifier
25280804
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.
Results Reference
derived

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Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

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