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

Recruiting

Conditions: Brain tumor
Glioma
10029211

Registration Number: NL-OMON55287

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

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

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 <70

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Fatigue severity at 14 weeks after randomization as measured by the CIS20<br /><br>subscale subjective fatigue will be the primary outcome. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The set of secondary study parameters, bearing potential to measure and predict<br /><br>treatment effects, will consist of questionnaires concerning quality of life<br /><br>and functioning, neuropsychological testing, neurological assesment, advanced<br /><br>neuroimaging and clinical parameters (tumor location, undergone previous<br /><br>treatments, medication use). The set of determinants, and primary and secondary<br /><br>outcomes will be measured at baseline and after the intervention at 14 weeks..<br /><br>Ten weeks after the measurement the questionnaires will be completed again. </p><br>