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Behavioral Intervention

Cognitive Behavioral Therapy for Insomnia for Cancer-Related Fatigue

N/A
Recruiting
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of organ-confined BC
Treatment with RT
Must not have
History of untreated obstructive sleep apnea (OSA [defined as an apnea-hypopnea index ≥ 10]) or above threshold scores on the STOP-BANG
Do not have a diagnosis of BC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of treatment (up to 12 weeks)
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether a higher dose of CBT-I is more effective in treating cancer-related fatigue than the standard dose.

Who is the study for?
This trial is for breast cancer patients aged 25-85 who are experiencing both insomnia and cancer-related fatigue, without significant medical conditions like sleep apnea or psychiatric disorders. Participants must not have metastatic disease, untreated sleep apnea, a history of narcolepsy, substance dependence, or work night shifts.
What is being tested?
The study tests whether different doses of Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep duration and reduce fatigue in breast cancer patients. It aims to understand if adjusting the amount of CBT-I can lead to better quality of life and survivorship outcomes.
What are the potential side effects?
CBT-I typically does not involve medication so it doesn't have physical side effects. However, participants may experience emotional discomfort discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is limited to the breast.
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I am currently undergoing or have completed radiation therapy.
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I am willing and able to give my consent for treatment.
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I do not have major health or psychiatric conditions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have untreated sleep apnea or high scores on the STOP-BANG test.
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I have not been diagnosed with breast cancer.
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I am younger than 25 or older than 85.
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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence
Recruitment
Retention
+1 more

Side effects data

From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624
1%
Hematoma R side abdomen
1%
Severe vaginal bleeding and pain
1%
Chest pain in a patient with CAD
1%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Antidepressant + Desensitization
Antidepressant + Cognitive Behavioral

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Twelve Sessions of CBT-IExperimental Treatment1 Intervention
Group II: Ten Sessions of CBT-IExperimental Treatment1 Intervention
Group III: Four Sessions of CBT-IExperimental Treatment1 Intervention
Group IV: Eight Sessions of CBT-IExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
413 Previous Clinical Trials
164,561 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,398 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,075 Previous Clinical Trials
42,719,776 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05226078 — N/A
Chronic Insomnia Research Study Groups: Eight Sessions of CBT-I, Ten Sessions of CBT-I, Four Sessions of CBT-I, Twelve Sessions of CBT-I
Chronic Insomnia Clinical Trial 2023: Cognitive Behavioral Therapy for Insomnia Highlights & Side Effects. Trial Name: NCT05226078 — N/A
Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05226078 — N/A
~26 spots leftby Nov 2025
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