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

RecruitingNAAges 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Ams…
NCT06511518 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Cognitive behavioral therapy
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Where

1 site
Medical Psychology
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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