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NCT Number: NCT06511518

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

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.

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Key information

Conditions

Cancer Neoplasms Palliative Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Psychology

Amsterdam, North Holland, 1105AZ, Netherlands

Location status: Recruiting

Location contact

Christine Henneman-Hoogeland, na

CONTACT

[email protected]

020 - 566 4661

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Solid (non-brain) tumor patients

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Primary outcomes

  1. Fatigue severity will be measured using the subscale fatigue severity (8 items, 7-point Likert scale) of the Checklist Individual Strength (CIS-fatigue).

    Time frame: Screening, baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)

    The CIS-fatigue has shown to be sensitive to change, has good reliability and discriminative validity. Scores range from 8 to 56. A score of ≥35 indicates severe fatigue. Change = (week 14 score - baseline score).

Secondary outcomes

  1. 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).

    Time frame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)

    The EORTC QLQ-C30 is developed for use in clinical trials in cancer patients. Total scores on each subscale are linearly converted to a 0 to 100 scale. Higher scores indicate more fatigue. Change = (week 14 score - baseline score).

  2. Quality of Life will be measured using the subscale global health status/QoL (2 items, 7-point Likert Scale) of the EORTC QLQ-C30.

    Time frame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)

    The EORTC QLQ-C30 is one of the most commonly used HRQoL instruments in the palliative setting and is known to be a reliable and valid measure of the quality of life of patients with cancer. A high score indicates good HRQoL. Change = (week 14 score - baseline score).

  3. 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.

    Time frame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)

    Raw scores for both subscales are convertible to a score of 0 to 100. A high score represents a high level of functioning. Change = (week 14 score - baseline score).

  4. Functional impairment will be assessed with the work and social adjustment scale (WSAS)

    Time frame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)

    Raw scores for both subscales are convertible to a score of 0 to 100. A high score represents a high level of functioning. Change = (week 14 score - baseline score).

  5. Healthcare consumption

    Time frame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)

    In order to estimate the healthcare costs related to fatigue we will compare the therapist time spent per patient within the TIRELESS project with the time spent per patient within the benchmark study (TIRED study).

    We will use an adapted version of a questionnaire on health consumption and productivity loss (TiC-P). At baseline, patients will be asked about their healthcare consumption over the past 4 months.The healthcare consumption during the four months of the intervention (study participation) will then be compared to the four months preceding the intervention. A group of 25 patients who are severely fatigued and eligible for study participation, but who do not want to participate will be asked if they are willing to complete the TiC-P at the same time points (T0, T1, T2) as the study participants. We then will compare health care consumption of these two groups.

  6. Usability of the e-health platform will be assessed using the System Usability Scale (SUS)

    Time frame: T1: week 14 after T0

    The System Usability Scale is a 10-item questionnaire rated on a 5-point Likert scale. The total SUS score ranges from 0 to 100, with higher scores indicating better perceived usability.

Study contacts

Contact information is provided by the study sponsor or research team.

Hans Knoop, Prof.

CONTACT

[email protected]

020 5666932

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Dutch Cancer Society

Registry information

Official study title

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

Acronym: TIRELESS

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 22, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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