Clinical trial NCT03561064: Improving Sleep in Cancer Patients: A Feasibility Trial
Official title: Improving Sleep in Cancer Patients: A Feasibility Trial of Implementing Cognitive Behavioral Therapy for Insomnia During Cancer Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Insomnia
Keywords: cancer
insomnia
CBT
CBT-I
cognitive behavioral therapy
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of the score on the Insomnia Severity Index (ISI)
timeFrame: baseline and at 19th week
Secondary outcomes:
measure: Change of diary-assessed sleep onset latency
timeFrame: baseline and at 19th week
measure: Change of diary-assessed wake after sleep onset
timeFrame: baseline and at 19th week
measure: Change of actigraphy-sleep onset latency
timeFrame: baseline and at 19th week
measure: Change of actigraphy-assessed wake after sleep onset
timeFrame: baseline and at 19th week
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Wai S Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: