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Cognitive Behavioral Therapy in treating severe fatigue in patients with primary brain tumors - a randomized controlled clinical trial

Cognitive Behavioral Therapy in treating severe fatigue in patients with primary brain tumors - a randomized controlled clinical trial - GRIP on fatigue

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55287
Enrollment
100
Registered
2020-05-29
Start date
2020-06-22
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain tumor Glioma

Interventions

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 (Mi

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: a. >= 18 years of age b. histological diagnosis of primary brain tumor c. severely fatigued (CIS20 subscale subjective fatigue >= 35) d. stable disease, i.e. no oncological treatment for >= 2 months prior to inclusion e. expected survival >= 3 months f. no signs of radiological or clinical tumor progression g. no corticosteroid use h. exclusion of other causes of fatigue other than brain tumor treatment, such as anemia or infection i. able to speak, read and write Dutch j. having access to a computer with internet

Exclusion criteria

Exclusion criteria: a. depression b. primary sleep disorders c. current psychological treatment for a psychiatric disorder d. current pregnancy or having given birth in the past 3 months e. pharmacological treatment for fatigue that was started in the past 3 months (e.g. Amantadine, Modafinil, Ritalin, Pemoline) f. Karnofsky performance score

Design outcomes

Primary

MeasureTime frame
Fatigue severity at 14 weeks after randomization as measured by the CIS20 subscale subjective fatigue will be the primary outcome.

Secondary

MeasureTime frame
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 14 weeks.. Ten weeks after the measurement the questionnaires will be completed again.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)