Improving Sleep in Cancer Patients: A Feasibility Trial

NCT03561064 | Completed

• 1 other identifier: D18087
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Insomnia

Keywords

cancer; insomnia; CBT; CBT-I; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of diary-assessed sleep onset latency

  baseline and at 19th week

• Change of diary-assessed wake after sleep onset

  baseline and at 19th week

• Change of actigraphy-sleep onset latency

  baseline and at 19th week

• Change of actigraphy-assessed wake after sleep onset

  baseline and at 19th week

Study Arms (1)

Receiving CBT-I

EXPERIMENTAL

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

Behavioral: CBT-I

Interventions

CBT-I BEHAVIORAL

Eligible participants will receive CBT-I by a licensed clinical psychologist.

Also known as: cognitive behavioral therapy for insomnia

Receiving CBT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• other sleep disorders;
• bipolar disorder;
• unmanaged serious mental illnesses;
• suicidal ideation/intent/plan;
• unstabilized pharmacological treatment for insomnia;
• night-shift employment.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Wai S Chan, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 19, 2018
• Study Start: April 13, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)