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

Abramson Cancer Center at Penn Medicine18 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Prostate Cancer

Interventions

Cognitive Behavioral therapy for insomnia (CBT-I)BEHAVIORAL

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

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

University Of Pennsylvania, Behavioral Sleep Medicine Program

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Fatigue

Fatigue, as measured by the Multidimensional Fatigue Symptom Inventory-Short Form and the FACIT-Fatigue scale.

Time frame: From enrollment to three months post-treatment

Insomnia Severity

As measured by the Insomnia Severity Index

Time frame: From enrollment to post-treatment, and 3 months post-treatment

Secondary Outcomes

Sleep Continuity

As measured by the daily sleep diary, including sleep latency, number of awakenings, wake after sleep onset, total sleep time and sleep efficiency.

Time frame: From enrollment to post-treatment, and 3 months post-treatment.]

Data from ClinicalTrials.gov

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