Cognitive Rehabilitation of Glioma Patients

Glioma Clinical Trial

Official title:

Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00256425
• Other study ID #: UU 2003-2783
• Status: Unknown status
• Phase: Phase 3
• First received: November 18, 2005
• Last updated: March 20, 2008
• Start date: October 2003
• Est. completion date: September 2007

Study information

• Verified date: July 2007
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 140
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Glioma

Intervention

Behavioral:
• Cognitive rehabilitation

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	VU Medical Center	Amsterdam
Netherlands	Medical Center Haaglanden	Den Haag
Netherlands	UMC Groningen	Groningen
Netherlands	AZ Maastricht	Maastricht
Netherlands	UMC St Radboud	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Sint Elisabeth Hospital	Tilburg
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. Erratum in: Lancet. 2011 May 14;377(9778):1654. — View Citation

Taphoorn MJ, Klein M. Cognitive deficits in adult patients with brain tumours. Lancet Neurol. 2004 Mar;3(3):159-68. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuropsychological measures of attention (test scores)		baseline, immediately after 6 weeks and at 6-month follow-up
Secondary	neuropsychological measures of memory and executive functioning (test scores)		baseline, immediately after 6 weeks and at 6-month follow-up
Secondary	subjective neuropsychological functioning (questionnaires)		baseline, immediately after 6 weeks and at 6-month follow-up
Secondary	quality of life (questionnaires)		baseline, immediately after 6 weeks and at 6-month follow-up