Improving Sleep in Cancer Patients: A Feasibility Trial

Cancer Clinical Trial

— ISCAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561064
• Other study ID #: D18087
• Status: Completed
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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