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Cognitive Rehabilitation of Glioma Patients

Primary Purpose

Glioma, Cognition Disorders

Status
Unknown status
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Cognitive rehabilitation
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring glioma, brain tumor, cognit, neuropsycholog, attention, memory, executive function, rehabilitation, remediation, training

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult patients with a histologically proven low-grade glioma or presumed (i.e., suspected) low-grade glioma based on both clinical and MR imaging feature, and adult patients with an anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligo-astrocytoma) under age 50 and with good performance status (KPS > 70); who are clinically stable for a minimum of 6 months prior to study entry (as determined by recent CT or MRI imaging) and no anti-tumor treatment during that period of time (i.e., surgery, radiotherapy, chemotherapy, corticosteroids); who report at least one symptom of impaired cognitive functioning based on a standardized self-report questionnaire, administered by researcher; and who meet criteria for neuropsychological impairment based on objective test results (assessed by researcher). Exclusion Criteria: lack of basic proficiency in Dutch; IQ below 85; severe reading problems; an additional (history of) neurological or psychiatric disorder; participating in a concurrent study in which neuropsychological testing and/or health-related quality of life assessments are involved

Sites / Locations

  • VU Medical Center
  • Netherlands Cancer Institute
  • Medical Center Haaglanden
  • UMC Groningen
  • AZ Maastricht
  • UMC St Radboud
  • Erasmus Medical Center
  • Sint Elisabeth Hospital
  • University Medical Center Utrecht

Outcomes

Primary Outcome Measures

neuropsychological measures of attention (test scores)

Secondary Outcome Measures

neuropsychological measures of memory and executive functioning (test scores)
subjective neuropsychological functioning (questionnaires)
quality of life (questionnaires)

Full Information

First Posted
November 18, 2005
Last Updated
March 20, 2008
Sponsor
UMC Utrecht
Collaborators
Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT00256425
Brief Title
Cognitive Rehabilitation of Glioma Patients
Official Title
Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
UMC Utrecht
Collaborators
Dutch Cancer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether cognitive rehabilitation is effective in patients with gliomas (brain tumour), by comparing direct and follow-up neuropsychological functioning and quality of life of the experimental group to the control group.
Detailed Description
The majority of patients with (low-grade) glioma exhibit cognitive symptoms and objective deficits, which have a sustained, negative impact on daily functioning and quality of life. Adult patients with a low-grade glioma, either histologically proven, or suspected (1), as well as adult anaplastic glioma patients with favorable prognostic factors (2), who are clinically stable for at least 6 months, will be recruited from 9 hospitals in the Netherlands. Consenting patients with both subjective cognitive symptoms and objective deficits will be randomized to either the cognitive rehabilitation program (N = 75) or a "waiting-list" control group (N = 75). Upon completion of the study, those patients assigned to the control group will be given the opportunity to undergo the cognitive rehabilitation program. The cognitive rehabilitation program incorporates both retraining of impaired cognitive functions, and teaching of compensatory strategies. Rehabilitation will be directed towards attention, memory and executive functioning. The intervention will consist of 6 weekly, individual, 2-hour sessions plus two hours of homework. To evaluate the efficacy of the rehabilitation program, objective neuropsychological functioning, self-reported cognitive symptoms and health-related quality of life will be assessed before rehabilitation, directly following rehabilitation, and at 6-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Cognition Disorders
Keywords
glioma, brain tumor, cognit, neuropsycholog, attention, memory, executive function, rehabilitation, remediation, training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cognitive rehabilitation
Primary Outcome Measure Information:
Title
neuropsychological measures of attention (test scores)
Time Frame
baseline, immediately after 6 weeks and at 6-month follow-up
Secondary Outcome Measure Information:
Title
neuropsychological measures of memory and executive functioning (test scores)
Time Frame
baseline, immediately after 6 weeks and at 6-month follow-up
Title
subjective neuropsychological functioning (questionnaires)
Time Frame
baseline, immediately after 6 weeks and at 6-month follow-up
Title
quality of life (questionnaires)
Time Frame
baseline, immediately after 6 weeks and at 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients with a histologically proven low-grade glioma or presumed (i.e., suspected) low-grade glioma based on both clinical and MR imaging feature, and adult patients with an anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligo-astrocytoma) under age 50 and with good performance status (KPS > 70); who are clinically stable for a minimum of 6 months prior to study entry (as determined by recent CT or MRI imaging) and no anti-tumor treatment during that period of time (i.e., surgery, radiotherapy, chemotherapy, corticosteroids); who report at least one symptom of impaired cognitive functioning based on a standardized self-report questionnaire, administered by researcher; and who meet criteria for neuropsychological impairment based on objective test results (assessed by researcher). Exclusion Criteria: lack of basic proficiency in Dutch; IQ below 85; severe reading problems; an additional (history of) neurological or psychiatric disorder; participating in a concurrent study in which neuropsychological testing and/or health-related quality of life assessments are involved
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin JB Taphoorn, MD, PhD
Organizational Affiliation
Medical Center Haaglanden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil K Aaronson, PhD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margriet M Sitskoorn, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
VU Medical Center
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
Facility Name
Netherlands Cancer Institute
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Medical Center Haaglanden
City
Den Haag
ZIP/Postal Code
2501 CK
Country
Netherlands
Facility Name
UMC Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
AZ Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
UMC St Radboud
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
Sint Elisabeth Hospital
City
Tilburg
ZIP/Postal Code
5000 LC
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
12423981
Citation
Klein M, Heimans JJ, Aaronson NK, van der Ploeg HM, Grit J, Muller M, Postma TJ, Mooij JJ, Boerman RH, Beute GN, Ossenkoppele GJ, van Imhoff GW, Dekker AW, Jolles J, Slotman BJ, Struikmans H, Taphoorn MJ. Effect of radiotherapy and other treatment-related factors on mid-term to long-term cognitive sequelae in low-grade gliomas: a comparative study. Lancet. 2002 Nov 2;360(9343):1361-8. doi: 10.1016/s0140-6736(02)11398-5. Erratum In: Lancet. 2011 May 14;377(9778):1654.
Results Reference
background
PubMed Identifier
14980531
Citation
Taphoorn MJ, Klein M. Cognitive deficits in adult patients with brain tumours. Lancet Neurol. 2004 Mar;3(3):159-68. doi: 10.1016/S1474-4422(04)00680-5.
Results Reference
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Cognitive Rehabilitation of Glioma Patients

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