search
Back to results

Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery

Primary Purpose

Brain Tumor, Primary, Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
The cognitive rehabilitation program ReMind
Sponsored by
Elisabeth-TweeSteden Ziekenhuis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor, Primary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erasmus Medical CenterRecruiting
  • Medical Center HaaglandenRecruiting
  • Elisabeth-TweeSteden HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Early-intervention group

Waiting-list control group

Arm Description

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.

The waiting-list control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments one year after surgery.

Outcomes

Primary Outcome Measures

Change in objective cognitive functioning
Objective cognitive functioning is measured with the computerized test battery CNS Vital Signs
Change in working memory
Working memory is measured with the subtest Digit Span of the the Wechsler Adult Intelligence Scale (WAIS-III)
Change in word fluency
Word fluency is measured with the Letter Fluency test

Secondary Outcome Measures

Change in subjective cognitive functioning
Subjective cognitive functioning is measured with the Cognitive Failures Questionnaire (CFQ)
Change in symptoms of fatigue
Fatigue is measured with the Multidimensional Fatigue Inventory (MFI)
Change in symptoms of anxiety
Anxiety is measured with the Hospital Anxiety and Depression Scale (HADS)
Change in symptoms of depression
Depression is measured with the Hospital Anxiety and Depression Scale (HADS)
Change in subjective executive functioning
Subjective executive functioning is measured with the Behavior Rating Inventory of Executive Function
Change in professional functioning (1)
Professional functioning is measured with the Work Ability Index (WAI)
Change in professional functioning (2)
Professional functioning is measured with the Work Limitation Questionnaire (WLQ)
Change in (social) participation
Participation is measured with the Community Integration Questionnaire (CIQ)

Full Information

First Posted
September 5, 2017
Last Updated
February 12, 2018
Sponsor
Elisabeth-TweeSteden Ziekenhuis
Collaborators
Tilburg University, ZonMw: The Netherlands Organisation for Health Research and Development, Erasmus Medical Center, Medical Center Haaglanden
search

1. Study Identification

Unique Protocol Identification Number
NCT03373487
Brief Title
Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
Official Title
Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elisabeth-TweeSteden Ziekenhuis
Collaborators
Tilburg University, ZonMw: The Netherlands Organisation for Health Research and Development, Erasmus Medical Center, Medical Center Haaglanden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Primary, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Well-trained research assistants, who are conducting neuropsychological assessments, are blinded.
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early-intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting-list control group
Arm Type
Other
Arm Description
The waiting-list control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments one year after surgery.
Intervention Type
Behavioral
Intervention Name(s)
The cognitive rehabilitation program ReMind
Other Intervention Name(s)
ReMind-app
Intervention Description
Cognitive rehabilitation, i.e. psychoeducation, strategy training & retraining
Primary Outcome Measure Information:
Title
Change in objective cognitive functioning
Description
Objective cognitive functioning is measured with the computerized test battery CNS Vital Signs
Time Frame
3, 6, and 12 months after surgery
Title
Change in working memory
Description
Working memory is measured with the subtest Digit Span of the the Wechsler Adult Intelligence Scale (WAIS-III)
Time Frame
3, 6, and 12 months after surgery
Title
Change in word fluency
Description
Word fluency is measured with the Letter Fluency test
Time Frame
3, 6, and 12 months after surgery
Secondary Outcome Measure Information:
Title
Change in subjective cognitive functioning
Description
Subjective cognitive functioning is measured with the Cognitive Failures Questionnaire (CFQ)
Time Frame
3, 6, and 12 months after surgery
Title
Change in symptoms of fatigue
Description
Fatigue is measured with the Multidimensional Fatigue Inventory (MFI)
Time Frame
3, 6, and 12 months after surgery
Title
Change in symptoms of anxiety
Description
Anxiety is measured with the Hospital Anxiety and Depression Scale (HADS)
Time Frame
3, 6, and 12 months after surgery
Title
Change in symptoms of depression
Description
Depression is measured with the Hospital Anxiety and Depression Scale (HADS)
Time Frame
3, 6, and 12 months after surgery
Title
Change in subjective executive functioning
Description
Subjective executive functioning is measured with the Behavior Rating Inventory of Executive Function
Time Frame
3, 6, and 12 months after surgery
Title
Change in professional functioning (1)
Description
Professional functioning is measured with the Work Ability Index (WAI)
Time Frame
One day before surgery vs. 12 months after surgery
Title
Change in professional functioning (2)
Description
Professional functioning is measured with the Work Limitation Questionnaire (WLQ)
Time Frame
One day before surgery vs. 12 months after surgery
Title
Change in (social) participation
Description
Participation is measured with the Community Integration Questionnaire (CIQ)
Time Frame
One day before surgery vs. 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Gehring, PhD
Phone
+314664233
Email
k.gehring@uvt.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie D van der Linden, MSc
Phone
+31134662523
Email
s.d.vdrlinden@uvt.nl
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Djaina Satoer, PhD
Email
D.satoer@erasmusmc.nl
Facility Name
Medical Center Haaglanden
City
The Hague
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Dirven, PhD
Email
l.dirven@lumc.nl
Facility Name
Elisabeth-TweeSteden Hospital
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Gehring, PhD
Email
k.gehring@uvt.nl
First Name & Middle Initial & Last Name & Degree
Sophie D van der linden, MSc
Phone
+31134662523
Email
s.d.vdrlinden@uvt.nl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery

We'll reach out to this number within 24 hrs