Improving Sleep in Cancer Patients: A Feasibility Trial (ISCAP)

Dartmouth Health

Status: Completed

Conditions: Insomnia; Cancer

Treatments: Behavioral: CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT03561064

D18087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Receiving CBT-I

Experimental group

Description:

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

Treatment:

Behavioral: CBT-I