The Association Between CBT-I Dose and Innate Immunity in Insomnia and Fatigue in Prostate Cancer Patients

September 17, 2024 updated by: Abramson Cancer Center at Penn Medicine
The objective of this project is to test the association between Cognitive Behavioral Therapy for Insomnia dose (number of sessions), severity of cancer related fatigue, and levels of innate immunity biomarkers. Ultimately, this research will help to develop a better understanding of the underlying mechanisms of cancer related fatigue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to decreases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Behavioral Sleep Medicine Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of organ-confined breast cancer or prostate cancer
  • Received radiation treatment
  • Willing and able to provide informed consent
  • Endorse problem with both insomnia and cancer-related fatigue, as measured by the insomnia severity index, Multidimensional Fatigue Symptom Inventory (short form) and the Brief Fatigue Inventory

Exclusion Criteria:

  • History of obstructive Sleep Apnea
  • History of narcolepsy
  • Night shift work
  • Distant metastatic disease at presentation
  • Active drug/alcohol dependence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4-session
Participants randomized to this condition received 4 weekly CBT-I sessions.
Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy & stimulus control instructions; review of sleep hygiene; cognitive therapy [decatastrophization]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration.
Experimental: 8-session
Participants randomized to this condition received 8 weekly CBT-I sessions.
Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy & stimulus control instructions; review of sleep hygiene; cognitive therapy [decatastrophization]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration.
Experimental: 10-session
Participants randomized to this condition received 10 weekly CBT-I sessions.
Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy & stimulus control instructions; review of sleep hygiene; cognitive therapy [decatastrophization]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration.
Experimental: 12-session
Participants randomized to this condition received 12 weekly CBT-I sessions.
Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)
Cognitive Behavioral Therapy for Insomnia includes evaluation and orientation; data acquisition and delivery of sleep restriction therapy & stimulus control instructions; review of sleep hygiene; cognitive therapy [decatastrophization]; managing nonadherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: From enrollment to three months post-treatment
Fatigue, as measured by the Multidimensional Fatigue Symptom Inventory-Short Form and the FACIT-Fatigue scale.
From enrollment to three months post-treatment
Insomnia Severity
Time Frame: From enrollment to post-treatment, and 3 months post-treatment
As measured by the Insomnia Severity Index
From enrollment to post-treatment, and 3 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Continuity
Time Frame: From enrollment to post-treatment, and 3 months post-treatment.]
As measured by the daily sleep diary, including sleep latency, number of awakenings, wake after sleep onset, total sleep time and sleep efficiency.
From enrollment to post-treatment, and 3 months post-treatment.]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2020

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 834620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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