TY - JOUR
T1 - Reducing severe fatigue in patients with diffuse glioma
T2 - a study protocol for an RCT on the effect of blended cognitive behavioural therapy
AU - Röttgering, Jantine Geertruida
AU - Douw, Linda
AU - de Witt Hamer, Philip C
AU - Kouwenhoven, Mathilde C M
AU - Würdinger, Tom
AU - van de Ven, Peter M
AU - Sharpe, Louise
AU - Knoop, Hans
AU - Klein, Martin
N1 - Funding Information: This trial and the GRIP trial platform are funded by the Stichting Anita Veldman Foundation. The foundation is not involved in the design of the study; collection, analysis, and interpretation of data; and in writing the manuscript. Publisher Copyright: © 2022, The Author(s).
PY - 2022/12/1
Y1 - 2022/12/1
N2 - BACKGROUND: Fatigue is the most frequent and burdensome symptom of patients with diffuse glioma. It is closely linked to decreased health-related quality of life and symptoms such as depression and sleep disturbances. Currently, there is no evidence-based treatment that targets severe fatigue in patients with brain tumours. Cognitive behavioural therapy is aimed at fatigue-maintaining beliefs and behaviour. This therapy has been proven effective in reducing severe fatigue in cancer survivors and patients with multiple sclerosis. A blended therapy program combines sessions with a therapist with therapist-guided web-based therapy modules. The aim of this randomized controlled trial is to determine the efficacy of blended cognitive behavioural therapy in treating severe fatigue in patients with diffuse glioma.METHODS: We will include a maximum of 100 patients with diffuse glioma with clinically and radiologically stable disease and severe fatigue (i.e. Checklist Individual Strength, subscale fatigue severity ≥ 35). Patients will be randomized to blended cognitive behavioural therapy or a waiting list condition. The 12-week intervention GRIP on fatigue consists of five patient-therapist sessions and five to eight individualized web-based therapy modules supported by email contact. The primary outcome measure is fatigue severity. Secondary outcome measures include sleep quality, health-related quality of life, depression, anxiety, functional impairment and subjective and objective cognitive functioning. Primary and secondary outcome measures will be assessed at baseline and after 14 and 24 weeks. Magnetoencephalography and MRI will be used to evaluate potential biomarkers for intervention success. This trial has a Bayesian design: we will conduct multiple interim analyses to test for efficacy or futility of the trial. This is the first trial within the GRIP trial platform: a platform developing four to five different interventions for the most common symptoms in patients with diffuse glioma.DISCUSSION: The results of the GRIP on fatigue trial will provide information about the efficacy of this intervention on fatigue in patients with diffuse glioma. Multiple other outcomes and possible predictors of treatment success will also be explored.TRIAL REGISTRATION: Netherlands Trial Register NL8711 . Registered on 14 June 2020.
AB - BACKGROUND: Fatigue is the most frequent and burdensome symptom of patients with diffuse glioma. It is closely linked to decreased health-related quality of life and symptoms such as depression and sleep disturbances. Currently, there is no evidence-based treatment that targets severe fatigue in patients with brain tumours. Cognitive behavioural therapy is aimed at fatigue-maintaining beliefs and behaviour. This therapy has been proven effective in reducing severe fatigue in cancer survivors and patients with multiple sclerosis. A blended therapy program combines sessions with a therapist with therapist-guided web-based therapy modules. The aim of this randomized controlled trial is to determine the efficacy of blended cognitive behavioural therapy in treating severe fatigue in patients with diffuse glioma.METHODS: We will include a maximum of 100 patients with diffuse glioma with clinically and radiologically stable disease and severe fatigue (i.e. Checklist Individual Strength, subscale fatigue severity ≥ 35). Patients will be randomized to blended cognitive behavioural therapy or a waiting list condition. The 12-week intervention GRIP on fatigue consists of five patient-therapist sessions and five to eight individualized web-based therapy modules supported by email contact. The primary outcome measure is fatigue severity. Secondary outcome measures include sleep quality, health-related quality of life, depression, anxiety, functional impairment and subjective and objective cognitive functioning. Primary and secondary outcome measures will be assessed at baseline and after 14 and 24 weeks. Magnetoencephalography and MRI will be used to evaluate potential biomarkers for intervention success. This trial has a Bayesian design: we will conduct multiple interim analyses to test for efficacy or futility of the trial. This is the first trial within the GRIP trial platform: a platform developing four to five different interventions for the most common symptoms in patients with diffuse glioma.DISCUSSION: The results of the GRIP on fatigue trial will provide information about the efficacy of this intervention on fatigue in patients with diffuse glioma. Multiple other outcomes and possible predictors of treatment success will also be explored.TRIAL REGISTRATION: Netherlands Trial Register NL8711 . Registered on 14 June 2020.
KW - Blended cognitive behavioural therapy
KW - Cancer
KW - Digital health
KW - Fatigue
KW - Glioma
KW - Health-related quality of life
KW - Online intervention
KW - Psychosocial intervention
KW - Web-based
UR - http://www.scopus.com/inward/record.url?scp=85134260429&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-022-06485-5
DO - https://doi.org/10.1186/s13063-022-06485-5
M3 - Article
C2 - 35841104
SN - 1745-6215
VL - 23
SP - 568
JO - Trials
JF - Trials
IS - 1
M1 - 568
ER -