Clinical trial NCT03373487: Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
Official title: Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Tumor, Primary
Cognitive Impairment
Lead sponsor: Elisabeth-TweeSteden Ziekenhuis
Sponsor class: OTHER
Collaborators: name: Tilburg University
name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Erasmus Medical Center
name: Medical Center Haaglanden
First posted: 2017-12-14
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in objective cognitive functioning
timeFrame: 3, 6, and 12 months after surgery
measure: Change in working memory
timeFrame: 3, 6, and 12 months after surgery
measure: Change in word fluency
timeFrame: 3, 6, and 12 months after surgery
Secondary outcomes:
measure: Change in subjective cognitive functioning
timeFrame: 3, 6, and 12 months after surgery
measure: Change in symptoms of fatigue
timeFrame: 3, 6, and 12 months after surgery
measure: Change in symptoms of anxiety
timeFrame: 3, 6, and 12 months after surgery
measure: Change in symptoms of depression
timeFrame: 3, 6, and 12 months after surgery
measure: Change in subjective executive functioning
timeFrame: 3, 6, and 12 months after surgery
measure: Change in professional functioning (1)
timeFrame: One day before surgery vs. 12 months after surgery
measure: Change in professional functioning (2)
timeFrame: One day before surgery vs. 12 months after surgery
measure: Change in (social) participation
timeFrame: One day before surgery vs. 12 months after surgery
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: The Hague
country: Netherlands
facility: Medical Center Haaglanden
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Hospital
Study officials:
References: