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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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