Evidence map›Paper›PMID 42919196›Full record

ArticleBMC cancer2026

TIRELESS study protocol: non-inferiority study of nurse-led web-based cognitive behavioral therapy for cancer-related fatigue in patients with incurable cancer.

Hannah B van der Pas, Annemarie M J Braamse, Eline Boon, Jacoline E C Bromberg, Judith E Bosmans, Martin Klein, Pythia Nieuwkerk, Carin C D van der Rijt, Maurice J D L van der Vorst, Philip C de Witt Hamer and 2 more

Registry-linked trialAbstract readEquivalence Trial
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In one paragraph

Article in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06511518 (Making Cognitive Behavioral Therapy for Cancer-related Fatigue Fit for Implementation in Patients With Cancer Receiving Palliative Systemic Treatment), which is not on this map. Not yet cited in PubMed.

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0citing papers in PubMed
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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.

NCT06511518 narecruitingnot on this map

Making Cognitive Behavioral Therapy for Cancer-related Fatigue Fit for Implementation in Patients With Cancer Receiving Palliative Systemic Treatment

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2024 to 2028Enrolled56ConditionsCancer, Palliative TreatmentArmsCognitive behavioral therapy
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Hannah B van der PasDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands. h.b.vanderpas@amsterdamumc.nl.
Annemarie M J BraamseDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.
Eline BoonDepartment of Internal Medicine, VieCuri Medical Centre, Venlo, The Netherlands.
Jacoline E C BrombergDepartment of Neurology, Brain Tumor Center, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, Netherlands.
Judith E BosmansDepartment of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.
Martin KleinDepartment of Medical Psychology, Amsterdam UMC location Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, The Netherlands.
Pythia NieuwkerkDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.
Carin C D van der RijtDepartment of Medical Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Maurice J D L van der VorstDepartment of Internal Medicine, Center for Supportive and Palliative care, Rijnstate Hospital, Arnhem, The Netherlands.
Philip C de Witt HamerBrain Tumor Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.
Lia van ZuylenCancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, The Netherlands.
Hans KnoopDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands. hans.knoop@amsterdamumc.nl.

Funding

KWF Kankerbestrijding 14890
6 · The paper itself

Abstract

backgroundFatigue is a prevalent and debilitating symptom for patients with incurable cancer. Cognitive behavioral therapy (CBT) can significantly reduce cancer-related fatigue in this patient group. However, implementation of CBT into clinical care is difficult as the intervention is time-intensive, costly, and requires face-to-face consultations with a specialized CBT therapist. Since nurses already support patient with symptom management, including fatigue, internet supported CBT delivered by nurses could be a promising alternative for patients with incurable cancer. The primary aim of this study is to determine the non-inferiority of nurse-led web-based CBT in its effect on cancer-related fatigue, compared to CBT provided by CBT therapists.

methodsThe study is a prospective, non-randomized study using historical cohorts as the benchmark for comparison. Severely fatigued patients with incurable cancer of a solid tumor receive a 12-week nurse-led web-based CBT intervention. Primary and secondary outcome measures are assessed at baseline, post-intervention (14 weeks), and follow-up (26 weeks). The primary outcome measure is fatigue severity assessed with the Checklist Individual Strength (CIS-subscale fatigue severity). Secondary outcomes include functional impairment, quality of life and fatigue assessed with EORTC-QLQ-C30, and health care costs. Primary and secondary outcomes of the TIRELESS study and the benchmark are compared to determine non-inferiority. Non-inferiority of fatigue reduction is concluded if the upper bound of the one-sided 95% CI does not exceed + 5 on the CIS, with higher scores indicating more severe fatigue. In addition, interviews are conducted to gain insight in nurses' and patients' experiences with the intervention. These data are analyzed applying a thematic analysis method. Recruitment has started in June 2024. DISCUSSION: Especially for this burdened patient group, integration of CBT for fatigue in routine medical care is essential. With the TIRELESS study, we aim to reduce patient burden, foster scalability and accessibility of CBT for fatigue, and increase patients' self-management. If this approach is non-inferior to the original evidence-based (benchmark) intervention, this will enable implementation of cancer-related fatigue interventions for the growing group of patients with incurable cancer.

trial registrationNCT06511518; date of registration: 23/02/2024.

Indexed as

Cognitive Behavioral TherapyFatigueInternet-Based InterventionNeoplasmsFemaleHumansInternetMaleMiddle AgedProspective StudiesQuality of LifeTreatment OutcomeCancer-related fatigueCognitive behavioral therapyIncurable cancerPalliative careQuality of life

Identifiers

PMID42919196

What OpenQuestion holds

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Registered trials

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.