Improving Sleep in Cancer Patients: A Feasibility Trial

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.

Inclusion criteria

• 18+ 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.

Exclusion criteria

• 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.