Brain Tumor, PrimaryNCT03373487
Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
A study testing The cognitive rehabilitation program ReMind in people with Brain Tumor, Primary and Cognitive Impairment, run by Elisabeth-TweeSteden Ziekenhuis at 3 sites in Netherlands.
Trial summary
Many patients with primary brain tumors experience cognitive deficits and cognitive rehabilitation programs aim to alleviate these deficits.The cognitive rehabilitation program developed by the investigators proved effective in a large randomized controlled trial (RCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Primary, Cognitive Impairment
- What is being tested?
- The cognitive rehabilitation program ReMind
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Jul 2015to 30 Jun 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The adult patient has a (supratentorial or infratentorial) brain tumor that is radiologically suspect for either a meningioma or low grade glioma
- The patient will undergo resective surgery for the brain tumor
Who cannot join
- tumor resection in the last year
- progressive neurological disease
- diagnose of (acute) psychiatric or neurological disorders in the last 2 years
- chemotherapy in the last 2 years
- Karnovsky Performance Scale under 70
- Surgery-related complication (morbidity or mortality e.g., thrombosis or heart attack)
Show all 10Show fewer
- Lack of basic proficiency in Dutch
- IQ below 85, or (very) low cognitive skills
- Insufficient reading skills/visual impairment (limiting the ability to follow the cognitive rehabilitation program).
- Clinical referral to cognitive rehabilitation
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam
Djaina Satoer, PhD, D.satoer@erasmusmc.nl
- Recruiting
Medical Center Haaglanden
The Hague
Linda Dirven, PhD, l.dirven@lumc.nl
- Recruiting
Elisabeth-TweeSteden Hospital
Tilburg, 5022 GC
Karin Gehring, PhD, k.gehring@uvt.nl
Sophie D van der linden, MSc, +31134662523, s.d.vdrlinden@uvt.nl
About this study
Many patients with primary brain tumors experience cognitive deficits and cognitive rehabilitation programs aim to alleviate these deficits.The cognitive rehabilitation program developed by the investigators proved effective in a large randomized controlled trial (RCT). To increase its accessibility, it was converted into the iPad-based cognitive rehabilitation program ReMind, which incorporates psychoeducation, strategy training and retraining. A pilot study and a randomized controlled trial are conducted, to evaluate the feasibility of the use of the program and the efficacy of the program in brain tumor patients after resective surgery.
Read the detailed description
OBJECTIVE: To evaluate the immediate and longer-term effects of early cognitive telerehabilitation on cognitive performance and self-reported symptoms/functioning in patients with low-grade gliomas and meningiomas, in a prospective randomized trial.
HYPOTHESIS: Cognitive telerehabilitation after brain tumor surgery has both immediate and longer-term beneficiary effects on cognitive functioning and patient-reported outcomes.
STUDY DESIGN: In the first 6 months of the project a feasibility study will be conducted to ensure that adherence, patient experience, and potential attrition are acceptable.
Subsequently, a prospective randomized (waiting-list) controlled trial (RCT) will be performed. Information from the feasibility study will be used to modify the RCT when necessary. In the RCT, patients are randomized to early cognitive rehabilitation (3 months after surgery) or to a waiting-list control condition. The waiting-list control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments. Assessment of cognitive performance and self-reported symptoms will be performed prior to surgery (T0), before cognitive rehabilitation (3 months after surgery, T3), immediately after cognitive rehabilitation (6 months after surgery, T6), and at half-year follow up (12 months after surgery, T12).
STUDY POPULATION/SAMPLE SIZE: Patients with presumed low-grade glioma or meningioma, who are scheduled for resective surgery, will be included in the study. Fifteen patients will be invited in feasibility study. Based on the yearly numbers of meningioma and low-grade glioma patients that are operated in the Elisabeth-TweeSteden Hospital Tilburg, it is expected that 60 patients will be randomized in the RCT per year for 2.5 years. With a maximum attrition rate of 33%, a minimum of 100 patients (50 per group) will be evaluated.
INTERVENTION: An evidence-based cognitive rehabilitation program that is provided via a tablet app. The program consists of retraining, and teaching and practicing of compensational strategies of attention, memory and executive functioning. Patients spend 3 hours per week during 2.5 month in this home-based program. They are monitored and supervised by a trainer.
OUTCOME MEASURES: Feasibility (accrual, attrition, adherence, patient experience) will be monitored in the feasibility study.
At several time points during the RCT, patients will be tested with the computerized test battery (for cognition; CNS VS), two additional cognitive tests and several self-report questionnaires. Testing is done prior to surgery, prior to cognitive rehabilitation (3 months), immediately after cognitive rehabilitation (6 months) and at half-year follow up (12 months post-surgery). Questionnaires on self-reported cognitive functioning, psychological symptoms (anxiety and depression), and fatigue will be administered on all assessments; the questionnaires on work status, professional functioning and community integration are administered at baseline and one-year follow-up only.
- Conditions
- Brain Tumor, Primary, Cognitive Impairment
- Being tested
- The cognitive rehabilitation program ReMind
- Medical subject headings
- Brain Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The cognitive rehabilitation program ReMindBehavioural
Also called ReMind-app
Cognitive rehabilitation, i.e. psychoeducation, strategy training \& retraining
| Study group | Role | What they receive |
|---|---|---|
| Early-intervention group | Experimental | Patients follow the evidence-based cognitive rehabilitation program ReMind, which is provided via an iPad. It incorporates psychoeducation, strategy training and retraining. The intervention commenced 3 months after surgery and patients were advised to spend 3 hours per week on the program for 10 weeks. Receives: Behavioral: The cognitive rehabilitation program ReMind |
| Waiting-list control group | Other | The waiting-list control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments one year after surgery. Receives: Behavioral: The cognitive rehabilitation program ReMind |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objective cognitive functioning
Objective cognitive functioning is measured with the computerized test battery CNS Vital Signs
Measured: 3, 6, and 12 months after surgery
Change in working memory
Working memory is measured with the subtest Digit Span of the the Wechsler Adult Intelligence Scale (WAIS-III)
Measured: 3, 6, and 12 months after surgery
Change in word fluency
Word fluency is measured with the Letter Fluency test
Measured: 3, 6, and 12 months after surgery
Secondary outcomes (8)
Change in subjective cognitive functioning
Subjective cognitive functioning is measured with the Cognitive Failures Questionnaire (CFQ)
Measured: 3, 6, and 12 months after surgery
Change in symptoms of fatigue
Fatigue is measured with the Multidimensional Fatigue Inventory (MFI)
Measured: 3, 6, and 12 months after surgery
Change in symptoms of anxiety
Anxiety is measured with the Hospital Anxiety and Depression Scale (HADS)
Measured: 3, 6, and 12 months after surgery
Change in symptoms of depression
Depression is measured with the Hospital Anxiety and Depression Scale (HADS)
Measured: 3, 6, and 12 months after surgery
Change in subjective executive functioning
Subjective executive functioning is measured with the Behavior Rating Inventory of Executive Function
Measured: 3, 6, and 12 months after surgery
Change in professional functioning (1)
Professional functioning is measured with the Work Ability Index (WAI)
Measured: One day before surgery vs. 12 months after surgery
Change in professional functioning (2)
Professional functioning is measured with the Work Limitation Questionnaire (WLQ)
Measured: One day before surgery vs. 12 months after surgery
Change in (social) participation
Participation is measured with the Community Integration Questionnaire (CIQ)
Measured: One day before surgery vs. 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Jul 2015
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor, PrimaryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisabeth-TweeSteden Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- Tilburg University, ZonMw: The Netherlands Organisation for Health Research and Development, Erasmus Medical Center, Medical Center Haaglanden
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373487
- Sponsor's protocol ID
- 842003009
- Status last verified
- Oct 2017
- First submitted
- 5 Sep 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
- ClinicalTrials.gov ID
- NCT03373487
- Acronym / sponsor ID
- 842003009
- Conditions
- Brain Tumor, Primary, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Elisabeth-TweeSteden ZiekenhuisUniversity, hospital or other
- Collaborators
- Tilburg University, ZonMw: The Netherlands Organisation for Health Research and Development, Erasmus Medical Center, Medical Center Haaglanden
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 14 Dec 2017 (actual)
- 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.
Many patients with primary brain tumors experience cognitive deficits and cognitive rehabilitation programs aim to alleviate these deficits.The cognitive rehabilitation program developed by the investigators proved effective in a large randomized controlled trial (RCT). To increase its accessibility, it was converted into the iPad-based cognitive rehabilitation program ReMind, which incorporates psychoeducation, strategy training and retraining. A pilot study and a randomized controlled trial are conducted, to evaluate the feasibility of the use of the program and the efficacy of the program in brain tumor patients after resective surgery.
Detailed description
OBJECTIVE: To evaluate the immediate and longer-term effects of early cognitive telerehabilitation on cognitive performance and self-reported symptoms/functioning in patients with low-grade gliomas and meningiomas, in a prospective randomized trial.
HYPOTHESIS: Cognitive telerehabilitation after brain tumor surgery has both immediate and longer-term beneficiary effects on cognitive functioning and patient-reported outcomes.
STUDY DESIGN: In the first 6 months of the project a feasibility study will be conducted to ensure that adherence, patient experience, and potential attrition are acceptable.
Subsequently, a prospective randomized (waiting-list) controlled trial (RCT) will be performed. Information from the feasibility study will be used to modify the RCT when necessary. In the RCT, patients are randomized to early cognitive rehabilitation (3 months after surgery) or to a waiting-list control condition. The waiting-list control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments. Assessment of cognitive performance and self-reported symptoms will be performed prior to surgery (T0), before cognitive rehabilitation (3 months after surgery, T3), immediately after cognitive rehabilitation (6 months after surgery, T6), and at half-year follow up (12 months after surgery, T12).
STUDY POPULATION/SAMPLE SIZE: Patients with presumed low-grade glioma or meningioma, who are scheduled for resective surgery, will be included in the study. Fifteen patients will be invited in feasibility study. Based on the yearly numbers of meningioma and low-grade glioma patients that are operated in the Elisabeth-TweeSteden Hospital Tilburg, it is expected that 60 patients will be randomized in the RCT per year for 2.5 years. With a maximum attrition rate of 33%, a minimum of 100 patients (50 per group) will be evaluated.
INTERVENTION: An evidence-based cognitive rehabilitation program that is provided via a tablet app. The program consists of retraining, and teaching and practicing of compensational strategies of attention, memory and executive functioning. Patients spend 3 hours per week during 2.5 month in this home-based program. They are monitored and supervised by a trainer.
OUTCOME MEASURES: Feasibility (accrual, attrition, adherence, patient experience) will be monitored in the feasibility study.
At several time points during the RCT, patients will be tested with the computerized test battery (for cognition; CNS VS), two additional cognitive tests and several self-report questionnaires. Testing is done prior to surgery, prior to cognitive rehabilitation (3 months), immediately after cognitive rehabilitation (6 months) and at half-year follow up (12 months post-surgery). Questionnaires on self-reported cognitive functioning, psychological symptoms (anxiety and depression), and fatigue will be administered on all assessments; the questionnaires on work status, professional functioning and community integration are administered at baseline and one-year follow-up only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early-intervention group | Experimental | Behavioral: The cognitive rehabilitation program ReMindPatients follow the evidence-based cognitive rehabilitation program ReMind, which is provided via an iPad. It incorporates psychoeducation, strategy training and retraining. The intervention commenced 3 months after surgery and patients were advised to spend 3 hours per week on the program for 10 weeks. |
| Waiting-list control group | Other | Behavioral: The cognitive rehabilitation program ReMindThe waiting-list control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments one year after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The adult patient has a (supratentorial or infratentorial) brain tumor that is radiologically suspect for either a meningioma or low grade glioma
- The patient will undergo resective surgery for the brain tumor
Key exclusion criteria (10 listed)
- tumor resection in the last year
- progressive neurological disease
- diagnose of (acute) psychiatric or neurological disorders in the last 2 years
- chemotherapy in the last 2 years
- Karnovsky Performance Scale under 70
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 |
|---|---|---|
| The cognitive rehabilitation program ReMindAlso: ReMind-appCognitive rehabilitation, i.e. psychoeducation, strategy training \& retraining | Behavioural | Early-intervention group, Waiting-list control group |
Primary outcome
Change in objective cognitive functioning
Time frame: 3, 6, and 12 months after surgery
Objective cognitive functioning is measured with the computerized test battery CNS Vital Signs
Change in working memory
Time frame: 3, 6, and 12 months after surgery
Working memory is measured with the subtest Digit Span of the the Wechsler Adult Intelligence Scale (WAIS-III)
Change in word fluency
Time frame: 3, 6, and 12 months after surgery
Word fluency is measured with the Letter Fluency test
8 secondary outcomes
Change in subjective cognitive functioning
Time frame: 3, 6, and 12 months after surgery
Change in symptoms of fatigue
Time frame: 3, 6, and 12 months after surgery
Change in symptoms of anxiety
Time frame: 3, 6, and 12 months after surgery
Change in symptoms of depression
Time frame: 3, 6, and 12 months after surgery
Change in subjective executive functioning
Time frame: 3, 6, and 12 months after surgery
Change in professional functioning (1)
Time frame: One day before surgery vs. 12 months after surgery
Change in professional functioning (2)
Time frame: One day before surgery vs. 12 months after surgery
Change in (social) participation
Time frame: One day before surgery vs. 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The cognitive rehabilitation program ReMind in people with Brain Tumor, Primary and Cognitive Impairment, run by Elisabeth-TweeSteden Ziekenhuis at 3 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 2 inclusion and 10 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 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Contact Karin Gehring, PhD (+314664233, k.gehring@uvt.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in objective cognitive functioning (time frame: 3, 6, and 12 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2018.