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:

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.