Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511518
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-23
Brief Title:
Cognitive Behavioral Therapy for Cancer-related Fatigue in Patients With Cancer Receiving Palliative Systemic Treatment
Sponsor:
None
Organization:
None
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:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None