Clinical trial NCT06511518: Cognitive Behavioral Therapy for Cancer-related Fatigue in Patients With Cancer Receiving Palliative Systemic Treatment
Official title: Making Cognitive Behavioral Therapy for Cancer-related Fatigue Fit for Implementation in Patients With Cancer Receiving Palliative Systemic Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Palliative Treatment
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2024-07-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer-related fatigue is highly prevalent in patients with cancer receiving palliative treatment 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. 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 goal of this interventional study is to integrate interdisciplinary web-based CBT (inter-CBT) into clinical practice and prove non-inferiority in achieving a reduction in fatigue compared to face-to-face- CBT in patients with cancer receiving palliative treatment.

The main aims to answer are:

* To determine the non-inferiority of inter-CBT, compared to a benchmark study where 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 (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.

Participant 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 criteria: Inclusion Criteria:

* Receive systemic treatment with palliative intent for a solid tumor.
* Treatments include chemotherapy, targeted therapy, immunotherapy, and hormone therapy, possibly combined with surgery and/or radiation therapy
* Are ≥18 years old
* Are proficient in Dutch
* Report severe fatigue (Checklist Individual Strength, fatigue severity subscale \[CIS-fatigue\] score ≥35) with no known somatic explanation other than cancer and/or cancer treatment
* A life expectancy of ≥6 months according to their oncologist
* Access to a device with internet.

Exclusion Criteria:

* Symptomatic brain metastases
* Have a poor performance status (Karnofsky \<70)
* Are currently receiving treatment for a mental disorder.

Primary outcomes:
measure: Fatigue severity will be measured using the subscale fatigue severity (8 items, 7-point Likert scale) of the Checklist Individual Strength (CIS-fatigue).
timeFrame: Screening, baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Secondary outcomes:
measure: 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).
timeFrame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
measure: Quality of Life will be measured using the subscale global health status/QoL (2 items, 7-point Likert Scale) of the EORTC QLQ-C30.
timeFrame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
measure: 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.
timeFrame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
measure: Functional impairment will be assessed with the work and social adjustment scale (WSAS)
timeFrame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
measure: Healthcare consumption
timeFrame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Medical Psychology
state: Noord-Holland
Study officials:
References:
citation: 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/s12885-017-3076-0.