Status:
ACTIVE_NOT_RECRUITING
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Insomnia
Cancer-related Problem/Condition
Eligibility:
FEMALE
25-85 years
Phase:
NA
Brief 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 underlyin...
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 a...
Eligibility Criteria
Inclusion
- The diagnosis of organ-confined BC;
- Treatment with RT;
- Willingness and ability to provide informed consent;
- 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;
- and/or they do not have any significant medical (e.g., OSA; COPD) and/or psychiatric diagnoses (e.g., PTSD).
Exclusion
- History of untreated obstructive sleep apnea (OSA \[defined as an apnea-hypopnea index ≥ 10\]) or above threshold scores on the STOP-BANG;
- History of narcolepsy;
- Night shift work;
- Distant metastatic disease at presentation;
- Active alcohol and/or drug dependence;
- They do not have a diagnosis of BC;
- They do not endorse insomnia, CRF and/or do not score within the significant ranges on the ISI, PROMIS 7a and/or the FACIT;
- They have a current diagnosis of significant medical and/or psychiatric disorders;
- And/or they are not between the ages of 25-85 years.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05226078
Start Date
March 1 2023
End Date
November 30 2026
Last Update
May 20 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104