The Association Between CBT-I Dose and Innate Immunity in Insomnia and Fatigue in Prostate Cancer Patients
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Sep 2020
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedFirst Submitted
Initial submission to the registry
September 17, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedSeptember 19, 2024
September 1, 2024
3 years
September 17, 2024
September 17, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Fatigue
Fatigue, as measured by the Multidimensional Fatigue Symptom Inventory-Short Form and the FACIT-Fatigue scale.
From enrollment to three months post-treatment
Insomnia Severity
As measured by the Insomnia Severity Index
From enrollment to post-treatment, and 3 months post-treatment
Secondary Outcomes (1)
Sleep Continuity
From enrollment to post-treatment, and 3 months post-treatment.]
Study Arms (4)
4-session
EXPERIMENTALParticipants randomized to this condition received 4 weekly CBT-I sessions.
8-session
EXPERIMENTALParticipants randomized to this condition received 8 weekly CBT-I sessions.
10-session
EXPERIMENTALParticipants randomized to this condition received 10 weekly CBT-I sessions.
12-session
EXPERIMENTALParticipants randomized to this condition received 12 weekly CBT-I sessions.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of obstructive Sleep Apnea
- History of narcolepsy
- Night shift work
- Distant metastatic disease at presentation
- Active drug/alcohol dependence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Of Pennsylvania, Behavioral Sleep Medicine Program
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2024
First Posted
September 19, 2024
Study Start
September 30, 2020
Primary Completion
October 1, 2023
Study Completion
June 30, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09