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Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery

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ClinicalTrials.gov Identifier: NCT03373487
Recruitment Status : Unknown
Verified October 2017 by Elisabeth-TweeSteden Ziekenhuis.
Recruitment status was:  Recruiting
First Posted : December 14, 2017
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Tilburg University
ZonMw: The Netherlands Organisation for Health Research and Development
Erasmus Medical Center
Medical Center Haaglanden
Information provided by (Responsible Party):
Elisabeth-TweeSteden Ziekenhuis

Study Description
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Brief 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). 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.

Condition or disease Intervention/treatment Phase
Brain Tumor, Primary Cognitive Impairment Behavioral: The cognitive rehabilitation program ReMind Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Well-trained research assistants, who are conducting neuropsychological assessments, are blinded.
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
Actual Study Start Date : July 1, 2015
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Early-intervention group
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.
 Behavioral: The cognitive rehabilitation program ReMind
Cognitive rehabilitation, i.e. psychoeducation, strategy training & retraining
Other Name: ReMind-app
Waiting-list control group
The waiting-list control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments one year after surgery.
 Behavioral: The cognitive rehabilitation program ReMind
Cognitive rehabilitation, i.e. psychoeducation, strategy training & retraining
Other Name: ReMind-app


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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)

  3. Change in word fluency [ Time Frame: 3, 6, and 12 months after surgery ]
    Word fluency is measured with the Letter Fluency test


Secondary Outcome Measures :
  1. Change in subjective cognitive functioning [ Time Frame: 3, 6, and 12 months after surgery ]
    Subjective cognitive functioning is measured with the Cognitive Failures Questionnaire (CFQ)

  2. Change in symptoms of fatigue [ Time Frame: 3, 6, and 12 months after surgery ]
    Fatigue is measured with the Multidimensional Fatigue Inventory (MFI)

  3. Change in symptoms of anxiety [ Time Frame: 3, 6, and 12 months after surgery ]
    Anxiety is measured with the Hospital Anxiety and Depression Scale (HADS)

  4. Change in symptoms of depression [ Time Frame: 3, 6, and 12 months after surgery ]
    Depression is measured with the Hospital Anxiety and Depression Scale (HADS)

  5. Change in subjective executive functioning [ Time Frame: 3, 6, and 12 months after surgery ]
    Subjective executive functioning is measured with the Behavior Rating Inventory of Executive Function

  6. Change in professional functioning (1) [ Time Frame: One day before surgery vs. 12 months after surgery ]
    Professional functioning is measured with the Work Ability Index (WAI)

  7. Change in professional functioning (2) [ Time Frame: One day before surgery vs. 12 months after surgery ]
    Professional functioning is measured with the Work Limitation Questionnaire (WLQ)

  8. Change in (social) participation [ Time Frame: One day before surgery vs. 12 months after surgery ]
    Participation is measured with the Community Integration Questionnaire (CIQ)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373487


Contacts
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Contact: Karin Gehring, PhD +314664233 k.gehring@uvt.nl
Contact: Sophie D van der Linden, MSc +31134662523 s.d.vdrlinden@uvt.nl

Locations
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Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Djaina Satoer, PhD       D.satoer@erasmusmc.nl   
Medical Center Haaglanden Recruiting
The Hague, Netherlands
Contact: Linda Dirven, PhD       l.dirven@lumc.nl   
Elisabeth-TweeSteden Hospital Recruiting
Tilburg, Netherlands, 5022 GC
Contact: Karin Gehring, PhD       k.gehring@uvt.nl   
Contact: Sophie D van der linden, MSc    +31134662523    s.d.vdrlinden@uvt.nl   
Sponsors and Collaborators
Elisabeth-TweeSteden Ziekenhuis
Tilburg University
ZonMw: The Netherlands Organisation for Health Research and Development
Erasmus Medical Center
Medical Center Haaglanden
More Information
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Responsible Party: Elisabeth-TweeSteden Ziekenhuis
ClinicalTrials.gov Identifier: NCT03373487    
Other Study ID Numbers: 842003009
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases