TIRELESS study protocol: non-inferiority study of nurse-led web-based cognitive behavioral therapy for cancer-related fatigue in patients with incurable cancer
9 affiliations
- 1Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam
- 2Department of Internal Medicine, VieCuri Medical Centre
- 3Department of Neurology, Brain Tumor Center, Erasmus MC Cancer Institute, University Medical Center Rotterdam
- 4Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute
- 5Department of Medical Psychology, Amsterdam UMC location Vrije Universiteit Amsterdam, De Boelelaan 1117
- 6Department of Medical Oncology, Erasmus MC Cancer Institute, University Medical Center Rotterdam
- 7Department of Internal Medicine, Center for Supportive and Palliative care, Rijnstate Hospital
- 8Brain Tumor Center, Cancer Center Amsterdam
- 9Cancer Center Amsterdam, Cancer Treatment and Quality of Life
Abstract
Background Fatigue 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. Methods The 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 registration NCT06511518; date of registration: 23/02/2024.
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BibTeX
@article{pas2026tireless,
title = {{TIRELESS study protocol: non-inferiority study of nurse-led web-based cognitive behavioral therapy for cancer-related fatigue in patients with incurable cancer}},
author = {Hannah B. van der Pas and Annemarie M.J. Braamse and Eline Boon and Jacoline E.C. Bromberg and Judith E. Bosmans and Martin Klein and Pythia Nieuwkerk and Carin C.D. van der Rijt and Maurice J.D.L. van der Vorst and Philip C. de Witt Hamer and Lia van Zuylen and Hans Knoop},
journal = {BMC Cancer},
year = {2026},
month = jul,
doi = {10.1186/s12885-026-16426-z},
url = {https://doi.org/10.1186/s12885-026-16426-z},
note = {CC BY},
}
RIS
TY - JOUR
TI - TIRELESS study protocol: non-inferiority study of nurse-led web-based cognitive behavioral therapy for cancer-related fatigue in patients with incurable cancer
AU - Hannah B. van der Pas
AU - Annemarie M.J. Braamse
AU - Eline Boon
AU - Jacoline E.C. Bromberg
AU - Judith E. Bosmans
AU - Martin Klein
AU - Pythia Nieuwkerk
AU - Carin C.D. van der Rijt
AU - Maurice J.D.L. van der Vorst
AU - Philip C. de Witt Hamer
AU - Lia van Zuylen
AU - Hans Knoop
PY - 2026
DA - 2026/07/01
JO - BMC Cancer
DO - 10.1186/s12885-026-16426-z
UR - https://doi.org/10.1186/s12885-026-16426-z
AB - Background Fatigue 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. Methods The 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 registration NCT06511518; date of registration: 23/02/2024.
SN - 1471-2407
ER -