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

Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to de-creases 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 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 Overview

• Status: Active, not recruiting
• Conditions: Chronic Insomnia; Cancer-related Problem/Condition; Cancer-Related Syndrome
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia

Detailed Description

Subjects will be randomized into one of four groups, four, eight, ten or twelve sessions. Sessions will be con-ducted weekly by Telehealth and will be modified based on the duration of treatment but all will include the following, evaluation and orientation; data acquisition and delivery of sleep restriction therapy & stimulus control instructions; review of sleep hygiene; cognitive therapy [decatastrophization]; managing non-adherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration. Treatment will be conducted by a master therapist via a HIPAA compliant video link.

All CBT-I related data will be obtained via dedicated internet websites built with RedCap, where subjects will be asked to complete weekly and monthly questionnaires. One website will be for use by subjects. One website will be for use by the therapist. The patient and therapist website will have a landing page (password entry), a login page, and an activities page (what questionnaires are due when). For an example of such a website, please see our pilot study, https://redcap.med.upenn.edu/surveys/?s=RXLLA7C4KJ (access using password "sleepstudy"). The patient website will contain daily sleep diaries, weekly severity measures of insomnia (ISI), sleepiness (ESS), fatigue (PROMIS 7a, Brief Fatigue Inventory, and FACIT-F), depression (PHQ-9), anxiety (GAD-7), a medical symptoms checklist.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The diagnosis of organ-confined BC;
2. Treatment with RT;
3. Willingness and ability to provide informed consent;
4. They endorse problems with both insomnia and CRF, as determined by a score within the significant ranges on the ISI, PROMIS 7a, BFI, and FACIT-F;
5. and/or they do not have any significant medical (e.g., OSA; COPD) and/or psychiatric diagnoses (e.g., PTSD).

Exclusion Criteria:

1. History of untreated obstructive sleep apnea (OSA [defined as an apnea-hypopnea index ≥ 10]) or above threshold scores on the STOP-BANG;
2. History of narcolepsy;
3. Night shift work;
4. Distant metastatic disease at presentation;
5. Active alcohol and/or drug dependence;
6. They do not have a diagnosis of BC;
7. They do not endorse insomnia, CRF and/or do not score within the significant ranges on the ISI, PROMIS 7a and/or the FACIT;
8. They have a current diagnosis of significant medical and/or psychiatric disorders;
9. And/or they are not between the ages of 25-85 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Four Sessions of CBT-I	Behavioral: Cognitive Behavioral Therapy for Insomnia; Cognitive behavioral treatment of insomnia; Other Names: CBT-I
Experimental: Eight Sessions of CBT-I	Behavioral: Cognitive Behavioral Therapy for Insomnia; Cognitive behavioral treatment of insomnia; Other Names: CBT-I
Experimental: Ten Sessions of CBT-I	Behavioral: Cognitive Behavioral Therapy for Insomnia; Cognitive behavioral treatment of insomnia; Other Names: CBT-I
Experimental: Twelve Sessions of CBT-I	Behavioral: Cognitive Behavioral Therapy for Insomnia; Cognitive behavioral treatment of insomnia; Other Names: CBT-I

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Proportion of screened eligible subjects who: complete a screener; enroll; and accept randomization.	Baseline to End of Treatment (Up to 12 weeks)
Adherence	Average adherence to Sleep Restriction Therapy (SRT) and Stimulus Control Therapy (SCT) [overall and by week] as measured by deviations between prescribed and actual times (from sleep diaries), overall and by group.	Baseline to End of Treatment (Up to 12 weeks)
Treatment Acceptability	Average Insomnia Treatment Acceptability Scale (ITAS) scores, overall and by group. Total score for each subscale is the average of the 8 items, with higher scores indicating greater willingness to utilize the treatment.	End of Treatment
Retention	Percent of subjects who complete the study, overall and by group.	Baseline to End of Treatment (Up to 12 weeks)

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Fatigue; Insomnia; CBT-I; Dose Response; Cancer-Related Fatigue
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neoplasms; Fatigue; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 850366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No