GliomaPhase 3NCT00256425
Cognitive Rehabilitation of Glioma Patients
A Phase 3 study testing Cognitive rehabilitation in people with Glioma and Cognition Disorders, run by UMC Utrecht at 9 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma, Cognition Disorders
- What is being tested?
- Cognitive rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 9 sitesNetherlands
- Study dates
- Oct 2003to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
VU Medical Center
Amsterdam, 1007 MB
Netherlands Cancer Institute
Amsterdam, 1066 CX
UMC Groningen
Groningen, 9700 RB
AZ Maastricht
Maastricht, 6202 AZ
UMC St Radboud
Nijmegen, 6500 HB
Erasmus Medical Center
Rotterdam, 3008 AE
Medical Center Haaglanden
The Hague, 2501 CK
Sint Elisabeth Hospital
Tilburg, 5000 LC
University Medical Center Utrecht
Utrecht, 3584 CX
About this study
Official title: Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study
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.
Read the 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.
- Conditions
- Glioma, Cognition Disorders
- Being tested
- Cognitive rehabilitation
- Keywords
- glioma, brain tumor, cognit, neuropsycholog, attention, memory, executive function, rehabilitation, remediation, training
- Medical subject headings
- Glioma, Cognition Disorders, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive rehabilitationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropsychological measures of attention (test scores)
Measured: baseline, immediately after 6 weeks and at 6-month follow-up
Secondary outcomes (3)
neuropsychological measures of memory and executive functioning (test scores)
Measured: baseline, immediately after 6 weeks and at 6-month follow-up
subjective neuropsychological functioning (questionnaires)
Measured: baseline, immediately after 6 weeks and at 6-month follow-up
quality of life (questionnaires)
Measured: baseline, immediately after 6 weeks and at 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startOct 2003
- Study completionSep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Investigators
- Martin JB Taphoorn, MD, PhD, Principal investigator, Medical Center HaaglandenNeil K Aaronson, PhD, Principal investigator, The Netherlands Cancer InstituteMargriet M Sitskoorn, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256425
- Sponsor's protocol ID
- UU 2003-2783
- Status last verified
- Jul 2007
- First submitted
- 18 Nov 2005
- Last updated
- 21 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12423981Taphoorn 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.
PubMed 14980531
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT00256425
- Acronym / sponsor ID
- UU 2003-2783
- Conditions
- Glioma, Cognition Disorders
- Keywords
- glioma, brain tumor, cognit, neuropsycholog, attention, memory, executive function, rehabilitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- Oct 2003
- Study completion
- Sep 2007 (estimated)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive rehabilitation | Behavioural | – |
Primary outcome
neuropsychological measures of attention (test scores)
Time frame: baseline, immediately after 6 weeks and at 6-month follow-up
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2008.
- Background: PubMed 12423981Klein 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.
- Background: PubMed 14980531Taphoorn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin JB Taphoorn, MD, PhD principal investigator
Medical Center Haaglanden
Neil K Aaronson, PhD principal investigator
The Netherlands Cancer Institute
Margriet M Sitskoorn, PhD principal investigator
UMC Utrecht
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive rehabilitation in people with Glioma and Cognition Disorders, run by UMC Utrecht at 9 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuropsychological measures of attention (test scores) (time frame: baseline, immediately after 6 weeks and at 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00256425, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2008.