Improving Sleep in Cancer Patients: A Feasibility Trial (ISCAP)

Improving Sleep in Cancer Patients: A Feasibility Trial of Implementing Cognitive Behavioral Therapy for Insomnia During Cancer Treatments

The purpose of this study is to determine if CBT-I (cognitive behavioral therapy for insomnia) is a feasible treatment for insomnia in individuals undergoing cancer treatment.

Study Overview

• Status: Completed
• Conditions: Cancer; Insomnia
• Intervention / Treatment: Behavioral: CBT-I

Detailed Description

This research study is a single arm feasibility trial in which all eligible participants receive five weekly sessions of CBT-I (cognitive behavioral therapy for insomnia) delivered before or during their cancer treatments. CBT-I is a non-drug behavioral treatment for insomnia and is considered the most effective treatment for insomnia. However, CBT-I is not routinely offered to cancer patients due to unknowns about its feasibility in this population. Data will be obtained at pre- and post-CBT-I and at eight-week follow-up, and will focus on acceptability, implementation, and efficacy in order to assess feasibility. The study will focus on cancer patients who are diagnosed with gastro-intestinal (GI) cancer.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18+ years of age
2. have insomnia disorder (SOL or WASO greater than 30 minutes for more than 6 nights in two weeks + daytime impairments)
3. are diagnosed with gastro-intestinal cancer;
4. have life expectancy > 6 months;
5. are fully ambulatory indicated by the provider-rated score of greater than 2 on the Eastern Cooperative Oncology Group (ECOG) performance measure;
6. will complete cancer treatments in no less than seven weeks, allowing for two weeks of assessments and five weeks of CBT-I;
7. are English-speaking and able to provide voluntary, written consent.

Exclusion Criteria:

1. unmanaged sleep apnea indicated by the scores on the STOP-BANG Questionnaire suggesting high risk for sleep apnea and not receiving any sleep apnea treatment;
2. other sleep disorders;
3. bipolar disorder;
4. unmanaged serious mental illnesses;
5. suicidal ideation/intent/plan;
6. unstabilized pharmacological treatment for insomnia;
7. night-shift employment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Receiving CBT-I; This is a single arm study. All participants will receive CBT-I (cognitive behavioral therapy for insomnia).	Behavioral: CBT-I; Eligible participants will receive CBT-I by a licensed clinical psychologist.; Other Names: cognitive behavioral therapy for insomnia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the score on the Insomnia Severity Index (ISI)	The ISI assesses the severity of insomnia symptoms and subjective daytime impairments.	baseline and at 19th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of diary-assessed sleep onset latency	Sleep onset latency is the time it takes to fall asleep	baseline and at 19th week
Change of diary-assessed wake after sleep onset	wake after sleep onset is the total duration of nighttime awakenings	baseline and at 19th week
Change of actigraphy-sleep onset latency	Sleep onset latency is the time it takes to fall asleep	baseline and at 19th week
Change of actigraphy-assessed wake after sleep onset	wake after sleep onset is the total duration of nighttime awakenings	baseline and at 19th week

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Wai S Chan, PhD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: cancer; insomnia; cognitive behavioral therapy; CBT; CBT-I
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: D18087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No