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

NCT ID: NCT06511518

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2026-02-01

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.

Conditions

Cancer; Palliative Treatment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Benchmark study

The results will be compared with those of a benchmark study, i.e. historical cohort of the same target group who received face-to-face CBT provided by psychologists in the TIRED study.

Group Type: OTHER

Cognitive behavioral therapy

Intervention Type: BEHAVIORAL

Cognitive behavioural therapy (CBT) is a therapy that can help you manage your problems by changing the way you think and behave.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Cancer Society

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Hans Knoop

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical Psychology

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Hans Knoop, Prof.

Role: CONTACT

hans.knoop@amsterdamumc.nl

020 5666932

Facility Contacts

Christine Henneman-Hoogeland

Role: primary

c.hennemanhoogeland@amsterdamumc.nl

020 - 566 4661

References

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.

Reference Type: RESULT

PMID: 28129746 (View on PubMed)

Related Links

https://bmccancer.biomedcentral.com/articles/10.1186/s12885-017-3076-0

TIRED trial, the benchmark study

Other Identifiers

NL85495.018.23

Identifier Type: -

Identifier Source: org_study_id