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

Официальное название

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

Обзор

Cancer-related fatigue is highly prevalent in patients receiving treatment for gliomas or palliative systemic treatment for cancer and is experienced as one of the most burdensome symptoms affecting patients' daily functioning and quality of life. From the KWF-sponsored TIRED trial, we concluded that cognitive behavioral therapy (CBT) is effective in reducing fatigue in cancer patients with severe fatigue during palliative systemic treatment and in glioma patients. However, in its current form, integration in routine medical care is difficult and scalability is a problem, as the intervention is time-intensive, requires face-to-face consults with a psychologists, and the availability of trained psychologists is limited. The investigators expect that inter-CBT will integrate well into clinical practice and prove non-inferior in achieving a reduction in fatigue compared to face-to-face CBT as investigated in the TIRED and GRIP study. It is further expected that the interviews will provide useful information to implement this intervention. The main aims to answer are: * To determine the non-inferiority of CBT primarily led by nurese, compared with benchmark studies in which CBT was provided by psychologists, in its effect on reduction in cancer-related fatigue * To adapt CBT delivery to the needs of patients treated with palliative intent and glioma (interdisciplinary web-based CBT for cancer-related fatigue. * To investigate its feasibility by evaluating the practical workability, acceptability, and burden for patients and health care providers. Participants will follow the 12 weeks CBT intervention online, mainly guided by their nurse. Participants will start with a face-to-face session with the psychologists, partly together with their nurse, to start with setting their treatment goals. Then, they will work on the modules that are applicable to them. During the CBT intervention there will be a face-to-face session with their nurse to discuss the progress of their goals. Finally, all participants will complete the therapy by realizing their treatment goals. The outcomes with respect to fatigue severity and participants' goals will be discussed by the nurse with the participant in the final, face-to-face sessions. The face-to-face sessions will take 30 to max. 45 minutes, except for the first session, which will take one hour of which the nurse will be present during 15 minutes. Researchers will compare the outcomes of the study to a benchmark study where CBT was provided by psychologists in its effect on reduction in cancer-related fatigue.

Вмешательства

• Поведенческое Cognitive behavioral therapy
  Cognitive behavioural therapy (CBT) is a therapy that can help you manage your problems by changing the way you think and behave.

Первичные конечные точки

• Fatigue severity will be measured using the subscale fatigue severity (8 items, 7-point Likert scale) of the Checklist Individual Strength (CIS-fatigue). [Срок оценки: Screening, baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)]

Вторичные конечные точки (6)

• Fatigue will be assessed with the symptom scale Fatigue ((3 items, 4-point Likert scale) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, version 3.0). [Срок оценки: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)]
• Quality of Life will be measured using the subscale global health status/QoL (2 items, 7-point Likert Scale) of the EORTC QLQ-C30. [Срок оценки: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)]
• Functional impairment will be measured using the subscales emotional functioning (4 items, 4-point Likert scale) and physical functioning (5 items, 4-point Likert scale, range 0 to 100) of the EORTC QLQ-C30. [Срок оценки: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)]
• Functional impairment will be assessed with the work and social adjustment scale (WSAS) [Срок оценки: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)]
• Healthcare consumption [Срок оценки: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)]
• Usability of the e-health platform will be assessed using the System Usability Scale (SUS) [Срок оценки: T1: week 14 after T0]

Критерии участия

Solid (non-brain) tumor patients

Критерии включения

• Receive systemic treatment with palliative intent for a solid (non-brain) tumor
• Are ≥18 years old
• Are proficient in Dutch
• Report severe fatigue (Checklist Individual Strength, fatigue severity subscale \[CIS-fatigue\] score ≥35)
• A life expectancy of ≥6 months according to their oncologist
• Access to a device with internet

Критерии исключения

• Symptomatic brain metastases
• Dual immunotherapy
• Have a poor performance status (Karnofsky <70)
• Are currently receiving treatment for a mental disorder.
• Treatable somatic cause that could explain the presence of severe fatigue (other than the underlying disease and the cancer treatment itself)
• Severe cognitive deficits

Glioma patients

Критерии включения

• Histologically confirmed diffuse glioma WHO grade 2, 3, or 4
• No oncological treatment for at least two months prior to inclusion
• Are ≥18 years old
• Are proficient in Dutch
• Report severe fatigue (Checklist Individual Strength, fatigue severity subscale \[CIS-fatigue\] score ≥35)
• A life expectancy of ≥3 months according to their oncologist
• Access to a device with internet

Критерии исключения

• Signs of radiological or clinical tumor progression at the time of inclusion
• Corticosteroid use
• Have a poor performance status (Karnofsky <70)
• Are currently receiving treatment for a mental disorder
• Treatable somatic cause that could explain the presence of severe fatigue (other than the underlying disease and the cancer treatment itself).
• Severe cognitive deficits

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Нидерланды · 1 центр

• Medical Psychology — Amsterdam

Публикации

• Gorter M, Rottgering JG, Belgers V, Blom MEC, Thomassen B, De Witt Hamer PC, Niers JM, Kouwenhoven MCM, Bienfait HP, Gathier CS, Compter A, Geurts M, Snijders TJ, van de Ven PM, Douw L, Knoop H, Klein M. Bayesian adaptive randomized trial of blended cognitive behavioral therapy for severe fatigue in stable diffuse glioma. Neuro Oncol. 2026 Mar 1;28(3):693-703. doi: 10.1093/neuonc/noaf256. PMID 41208030
• Poort H, Verhagen CA, Peters ME, Goedendorp MM, Donders AR, Hopman MT, Nijhuis-van der Sanden MW, Berends T, Bleijenberg G, Knoop H. Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer. BMC Cancer. 2017 Jan 28;17(1):81. doi: 10.1186/s12885-017-30 PMID 28129746

Идентификаторы

NCT: NCT06511518 · NL85495.018.23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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