Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-01-06 @ 10:22 PM
Study NCT ID:
NCT06511518
Status:
RECRUITING
Last Update Posted:
2024-07-22
First Post:
2024-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy for Cancer-related Fatigue in Patients With Cancer Receiving Palliative Systemic Treatment
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Organization:
Study Overview
Official Title:
Making Cognitive Behavioral Therapy for Cancer-related Fatigue Fit for Implementation in Patients With Cancer Receiving Palliative Systemic Treatment
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIRELESS
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: