Cognitive Rehabilitation of Glioma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by UMC Utrecht.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00256425
First received: November 18, 2005
Last updated: March 20, 2008
Last verified: July 2007
  Purpose

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.


Condition Intervention Phase
Glioma
Cognition Disorders
Behavioral: Cognitive rehabilitation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • neuropsychological measures of attention (test scores) [ Time Frame: baseline, immediately after 6 weeks and at 6-month follow-up ]

Secondary Outcome Measures:
  • neuropsychological measures of memory and executive functioning (test scores) [ Time Frame: baseline, immediately after 6 weeks and at 6-month follow-up ]
  • subjective neuropsychological functioning (questionnaires) [ Time Frame: baseline, immediately after 6 weeks and at 6-month follow-up ]
  • quality of life (questionnaires) [ Time Frame: baseline, immediately after 6 weeks and at 6-month follow-up ]

Enrollment: 140
Study Start Date: October 2003
Estimated Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256425

Locations
Netherlands
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
VU Medical Center
Amsterdam, Netherlands, 1007 MB
Medical Center Haaglanden
Den Haag, Netherlands, 2501 CK
UMC Groningen
Groningen, Netherlands, 9700 RB
AZ Maastricht
Maastricht, Netherlands, 6202 AZ
UMC St Radboud
Nijmegen, Netherlands, 6500 HB
Erasmus Medical Center
Rotterdam, Netherlands, 3008 AE
Sint Elisabeth Hospital
Tilburg, Netherlands, 5000 LC
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Dutch Cancer Society
Investigators
Principal Investigator: Martin JB Taphoorn, MD, PhD Medical Center Haaglanden
Principal Investigator: Neil K Aaronson, PhD The Netherlands Cancer Institute
Principal Investigator: Margriet M Sitskoorn, PhD UMC Utrecht
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00256425     History of Changes
Other Study ID Numbers: UU 2003-2783
Study First Received: November 18, 2005
Last Updated: March 20, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
glioma
brain tumor
cognit
neuropsycholog
attention
memory
executive function
rehabilitation
remediation
training

Additional relevant MeSH terms:
Glioma
Cognition Disorders
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014