Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery

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.

Study Overview

• Status: Unknown
• Conditions: Cognitive Impairment; Brain Tumor, Primary
• Intervention / Treatment: Behavioral: The cognitive rehabilitation program ReMind

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 Type: Interventional
• Enrollment (Anticipated): 115
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karin Gehring, PhD; Phone Number: +314664233; Email: k.gehring@uvt.nl
• Study Contact Backup: Name: Sophie D van der linden, MSc; Phone Number: +31134662523; Email: s.d.vdrlinden@uvt.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus Medical Center
    • Contact: Djaina Satoer, PhD; Email: D.satoer@erasmusmc.nl
  • The Hague, Netherlands
    • Recruiting
    • Medical Center Haaglanden
    • Contact: Linda Dirven, PhD; Email: l.dirven@lumc.nl
  • Tilburg, Netherlands, 5022 GC
    • Recruiting
    • Elisabeth-TweeSteden hospital
    • Contact: Sophie D van der linden, MSc; Phone Number: +31134662523; Email: s.d.vdrlinden@uvt.nl
    • Contact: Karin Gehring, PhD; Email: k.gehring@uvt.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: ReMind-app
OTHER: 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 Names: ReMind-app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in objective cognitive functioning	Objective cognitive functioning is measured with the computerized test battery CNS Vital Signs	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)	3, 6, and 12 months after surgery
Change in word fluency	Word fluency is measured with the Letter Fluency test	3, 6, and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective cognitive functioning	Subjective cognitive functioning is measured with the Cognitive Failures Questionnaire (CFQ)	3, 6, and 12 months after surgery
Change in symptoms of fatigue	Fatigue is measured with the Multidimensional Fatigue Inventory (MFI)	3, 6, and 12 months after surgery
Change in symptoms of anxiety	Anxiety is measured with the Hospital Anxiety and Depression Scale (HADS)	3, 6, and 12 months after surgery
Change in symptoms of depression	Depression is measured with the Hospital Anxiety and Depression Scale (HADS)	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	3, 6, and 12 months after surgery
Change in professional functioning (1)	Professional functioning is measured with the Work Ability Index (WAI)	One day before surgery vs. 12 months after surgery
Change in professional functioning (2)	Professional functioning is measured with the Work Limitation Questionnaire (WLQ)	One day before surgery vs. 12 months after surgery
Change in (social) participation	Participation is measured with the Community Integration Questionnaire (CIQ)	One day before surgery vs. 12 months after surgery

Collaborators and Investigators

• Sponsor: Elisabeth-TweeSteden Ziekenhuis
• Collaborators: Erasmus Medical Center; Medical Center Haaglanden; ZonMw: The Netherlands Organisation for Health Research and Development; Tilburg University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ANTICIPATED): June 30, 2019
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (ACTUAL): December 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 842003009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No