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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of treatment (up to 12 weeks)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of treatment

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

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

Primary outcome measures

Adherence

Recruitment

Retention

+1 more

Side effects data

From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624

Hematoma R side abdomen

Severe vaginal bleeding and pain

Chest pain in a patient with CAD

Asthma

100%

80%

60%

40%

20%

Study treatment Arm

Antidepressant + Desensitization

Antidepressant + Cognitive Behavioral

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

~1800

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,464 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,451 Total Patients Enrolled

University of PennsylvaniaLead Sponsor

2,002 Previous Clinical Trials

42,880,799 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

Frequently Asked Questions

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

Is geriatric care being offered to those over 65 years of age in this trial?

"The guidelines for this clinical trial stipulate that the minimum age to participate is 25 and the maximum age is 85."

Answered by AI

What criteria must an individual satisfy to be eligible for this trial?

"Through this clinical trial, 70 people aged between 25 and 85 with cancer are being enrolled. In order to participate in the study, candidates must meet the following criteria: A diagnosis of organ-confined BC; Consent for participation; Suffering from insomnia and CRF as indicated by ISI, PROMIS 7a and FACIT-F scores; Being free from any significant medical (e.g., OSA) or psychiatric conditions (e.g., PTSD); RT treatment completed prior to enrollment."

Answered by AI

Are there still available slots for individuals looking to join this research experiment?

"Based on clinicaltrials.gov, this scientific experiment is no longer actively searching for participants. First posted on 2/1/2023 and last updated on 10/31/2022, the study has closed its doors to potential candidates; however, there are 2808 other trials currently recruiting patients across the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients

Michael Perlis 2023. "The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05226078.

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