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Trial Title:
Cognitive Behavioral Therapy for Cancer-related Fatigue in Patients With Cancer Receiving Palliative Systemic Treatment
NCT ID:
NCT06511518
Condition:
Cancer
Palliative Treatment
Conditions: Official terms:
Fatigue
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Cognitive behavioral therapy
Description:
Cognitive behavioural therapy (CBT) is a therapy that can help you manage your problems
by changing the way you think and behave.
Arm group label:
Benchmark study
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical Psychology
Address:
City:
Amsterdam
Zip:
1105AZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Christine Henneman-Hoogeland
Phone:
020 - 566 4661
Email:
c.hennemanhoogeland@amsterdamumc.nl
Start date:
June 3, 2024
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Collaborator:
Agency:
Dutch Cancer Society
Agency class:
Other
Source:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06511518
https://bmccancer.biomedcentral.com/articles/10.1186/s12885-017-3076-0
