To investigate the efficacy of bCBT compared to usual care in severely fatigued patients with primary brain tumors.
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fatigue severity at 14 weeks after randomization as measured by the CIS20
subscale subjective fatigue will be the primary outcome.
Secondary outcome
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.
Background summary
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.
Study objective
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.
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.
Study burden and risks
Patients will be informed about a total study participation time of 24 weeks.
Patients in the bCBT group will receive treatment for their fatigue, which is
expected to be effective. Their benefit will be a decrease in fatigue. There
are no health risks. The burden of participating in this study is that patients
will have to complete mostly online additional questionnaires, invest time to
participate in the intervention and assessments of secondary outcome measures.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71503.029.19 |
| OMON | NL-OMON26739 |