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

Not Applicable

Completed

• Conditions: Breast Cancer; Prostate Cancer
• Interventions: Behavioral: Cognitive Behavioral therapy for insomnia (CBT-I)

• Registration Number: NCT06604247
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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.

Study Timeline

• Study Start: 2020-09-30
• Primary Completion: 2023-10-01
• Study Completion: 2024-06-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12-session	Cognitive Behavioral therapy for insomnia (CBT-I)	Participants randomized to this condition received 12 weekly CBT-I sessions.
4-session	Cognitive Behavioral therapy for insomnia (CBT-I)	Participants randomized to this condition received 4 weekly CBT-I sessions.
8-session	Cognitive Behavioral therapy for insomnia (CBT-I)	Participants randomized to this condition received 8 weekly CBT-I sessions.
10-session	Cognitive Behavioral therapy for insomnia (CBT-I)	Participants randomized to this condition received 10 weekly CBT-I sessions.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Sleep Continuity	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.

Trial Locations

Locations (1)

University Of Pennsylvania, Behavioral Sleep Medicine Program; 🇺🇸 Philadelphia, Pennsylvania, United States