Improving Sleep in Cancer Patients: A Feasibility Trial

Not Applicable

Completed

• Conditions: Cancer; Insomnia
• Interventions: Behavioral: CBT-I

• Registration Number: NCT03561064
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2018-04-13
• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-19
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Receiving CBT-I	CBT-I	This is a single arm study. All participants will receive CBT-I (cognitive behavioral therapy for insomnia).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States