NCT06604247

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Breast Cancer
• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-30
• Primary completion: 2023-10-01
• Completion: 2024-06-30
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States