GRIP on fatigue
- Conditions
- 10029305<p>Diffuse glioma</p>
- Registration Number
- NL-OMON26739
- Lead Sponsor
- Prof. dr. Martin Klein
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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
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>The primary outcome measure is the CIS-fatigue score at fourteen weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The set of secondary outcomes consists of several symptoms measured by questionnaires at baseline, fourteen weeks and twentyfour weeks, including depression, HRQOL and anxiety and objective neurocognitive functioning.</p><br>