Evidence map›Paper›PMID 35841104›Full record

ArticleTrials2022

Reducing severe fatigue in patients with diffuse glioma: a study protocol for an RCT on the effect of blended cognitive behavioural therapy.

Jantine Geertruida Röttgering, Linda Douw, Philip C de Witt Hamer, Mathilde C M Kouwenhoven, Tom Würdinger, Peter M van de Ven, Louise Sharpe, Hans Knoop, Martin Klein

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.9field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Predictors of initial engagement with an asynchronous cognitive behavioral stress management website among older women with nonmetastatic breast cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Trial
  3. Symptom network and latent profile analysis in patients after glioma surgery: a cross-sectional study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Palliative Care in Neuro-oncology: an Update.Current neurology and neuroscience reports · 2023
    Review
  11. Review
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 3 countries.

Jantine Geertruida RöttgeringAmsterdam UMC location Vrije Universiteit Amsterdam, Medical Psychology, De Boelelaan 1117, Amsterdam, The Netherlands. j.rottgering@amsterdamumc.nl.ORCID http://orcid.org/0000-0002-9392-3239
Linda DouwCancer Center Amsterdam, Brain Tumor Center, Amsterdam, The Netherlands.
Philip C de Witt HamerCancer Center Amsterdam, Brain Tumor Center, Amsterdam, The Netherlands.
Mathilde C M KouwenhovenCancer Center Amsterdam, Brain Tumor Center, Amsterdam, The Netherlands.
Tom WürdingerCancer Center Amsterdam, Brain Tumor Center, Amsterdam, The Netherlands.
Peter M van de VenAmsterdam UMC location Vrije Universiteit Amsterdam, Epidemiology and Data Science, Amsterdam, The Netherlands.
Louise SharpeThe School of Psychology, University of Sydney, Sydney, NSW, Australia.
Hans KnoopAmsterdam UMC location Vrije Universiteit Amsterdam, Medical Psychology, De Boelelaan 1117, Amsterdam, The Netherlands.
Martin KleinAmsterdam UMC location Vrije Universiteit Amsterdam, Medical Psychology, De Boelelaan 1117, Amsterdam, The Netherlands.
Amsterdam University Medical Centers · NLAthinoula A. Martinos Center for Biomedical Imaging · USDutch Cancer Society · NLPublic Health Service of Amsterdam · NLThe University of Sydney · AU

Funding

Stichting Anita Veldman Foundation CCA-2019-2-21
6 · The paper itself

Abstract

backgroundFatigue 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.

methodsWe 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 registrationNetherlands Trial Register NL8711 . Registered on 14 June 2020.

Indexed as

Cognitive Behavioral TherapyGliomaBayes TheoremFatigueHumansQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeBlended cognitive behavioural therapyCancerDigital healthFatigueGliomaHealth-related quality of lifeOnline interventionPsychosocial interventionWeb-based

Identifiers

PMID35841104
PMCPMC9287927
OpenAlexW4285492007

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.