NCT05226078

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: Female
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Chronic Insomnia
• Cancer-related Problem/Condition
• Cancer-Related Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia	Cognitive behavioral treatment of insomnia

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-08-31
• Completion: 2026-11-30
• First posted: 2022-02-07
• Last updated: 2025-05-20

Locations

1 site across 1 country: United States