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Behavioral Intervention

Cognitive Behavioral Therapy to manage cancer-related fatigue for Fatigue

N/A

Waitlist Available

Led By Sophie Lebel, PhD

Research Sponsored by University of Ottawa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes in self-efficacy at 1 month after the completion of the intervention

Awards & highlights

Study Summary

This trial is testing an intervention for cancer-related fatigue (CRF), which is a common and distressing side-effect of cancer and its treatments. The intervention is based on cognitive-behavioral therapy and will be delivered in a community setting. The goal is to make the intervention more accessible to cancer survivors in the Ottawa region who are experiencing CRF.

Eligible Conditions

Fatigue
Cancer
Cognitive Behavioral Therapy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one time, 1 month after completing the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one time, 1 month after completing the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and one time, 1 month after completing the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in baseline fatigue at one month

Changes in baseline fatigue at three months

Secondary outcome measures

Changes in baseline depression and anxiety at 1 month

Anxiety

Fatigue

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CBT intervention for cancer-related fatigueExperimental Treatment1 Intervention

Participants will receive 4 weekly sessions consisting of psycho-education around fatigue, pacing, journaling fatigue, relaxation training, CBT, and evidence-based tips to increase physical activity.

Group II: Wait-list control groupActive Control1 Intervention

Participants assigned to this arm wait about 3-months to receive the intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy to manage cancer-related fatigue

2022

N/A

~50

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Who is running the clinical trial?

University of OttawaLead Sponsor

205 Previous Clinical Trials

266,041 Total Patients Enrolled

Sophie Lebel, PhDPrincipal InvestigatorUniversity of Ottawa

1 Previous Clinical Trials

36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment still accept new participants?

"According to clinicaltrials.gov, which last updated this study on June 3rd 2022, recruiting for the trial is still ongoing since its original posting date of January 1st 2022."

Answered by AI

What aims are researchers attempting to achieve through this research?

"The primary outcome of this experiment, evaluated over a one month period post-intervention, is the alteration in fatigue from baseline. Secondary objectives include an assessment of quality of life and insomnia (FACIT-F score range 0 - 52) at 1 month, as well as physical activity levels (Godin Leisure-Time Exercise score range 0 - 119) at 3 months."

Answered by AI

How many participants has this trial enrolled so far?

"Affirmative. Submitted on the 1st of January 2022, and updated as recently as June 3rd 2022, clinicaltrials.gov indicates that this experiment is actively accepting participants from a single medical centre with a total target enrollment pool size of 50 patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Why am I Still Tired ? A Group for Cancer-related Fatigue

Sophie Lebel 2022. "Why am I Still Tired ? A Group for Cancer-related Fatigue". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05409638.