GRIP op vermoeidheid

Background of the study: Between 80% and 90% of patients with primary brain tumors experience fatigue that persists in one-third of patients for months and years after therapy. Up to 40% of fatigued brain tumor patients regard it as severe.Blended Cognitive Behavioral Therapy (bCBT), i.e. a combination of face-to-face sessions and web-based CBT, has been shown to be effective in reducing severe fatigue in several clinical populations, but not in patients with primary brain tumors. Objective of the study: To investigate the efficacy of bCBT compared to usual care in severely fatigued patients with primary brain tumors. Study design: This study is a monocenter randomized controlled clinical trial. At baseline, patients will be randomized to bCBT or care as usual. Study population: 100 adult patients with clinically stable primary brain tumors and severe fatigue (CIS20 subscale subjective fatigue ≥ 35) will be recruited. Intervention: BCBT consists of 5 patient-therapist contacts, either face-to-face, or via video-consultation and information and assignments in 5 to 8 web-based therapy modules delivered via an internet portal (Minddistrict) and supported by email contact with a therapist providing feedback on the progress made by the patient. The CBT will be applied by trained psychologists. Primary study parameters of the study: Fatigue severity at 14 weeks after randomization as measured by the CIS20 subscale subjective fatigue will be the primary outcome. Secondary study parameters of the study: The set of secondary study parameters, bearing potential to measure and predict treatment effects, will consist of questionnaires concerning quality of life and functioning, neuropsychological testing, neurological assesment, advanced neuroimaging and clinical parameters (tumor location, undergone previous treatments, medication use). The set of determinants, and primary and secondary outcomes will be measured at baseline and after the intervention at fourteen weeks. Ten weeks after the measurement the questionnaires will be completed again.

It is hypothesized that bCBT for severe fatigue will lead to clinical improvements in fatigue levels compared to usual care.

T0: Baseline before intervention T1: fourteen weeks after baseline T2: twentyfour weeks after baseline

GRIP on fatigue is a multimodal Dutch intervention with therapist sessions and online modules with therapist feedback. BCBT for cancer related fatigue in patients with a PBT is directed at beliefs and behaviour of the patients that contribute to the persistence of fatigue. The intervention lasts twelve weeks.