Cognitive Impairment Clinical Trial
Official title:
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.
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.
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