Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 132
- Locations
- 2
- Primary Endpoint
- Insomnia Severity Index
Study Overview
Brief Summary
The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.
Detailed Description
A randomized controlled clinical trial will be used to test the efficacy of this brief behavioral treatment compared to attention control on sleep, mood, functional, status and quality of life and determine predictors for efficacy of Brief Behavioral Treatment for Insomnia (BBTI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •> or = 4 weeks from surgery for cancer treatment; chemotherapy and/or radiation therapy; no wait for hormone therapy or targeted treatment for stage I, II, or III: breast, colorectal, prostate, lung cancer
- •chronic insomnia
Exclusion Criteria
- •Other preexisting sleep disorders except those with OSA stable on CPAP
- •Unstable medical illnesses
Arms & Interventions
Behavioral: Brief behavioral treatment for insomnia
Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.
Intervention: Brief behavioral treatment for insomnia (Behavioral)
Behavioral: Healthy eating control
Healthy eating control involves a 45 minute individual session with two follow up phone calls.
Intervention: Healthy Eating Control (Behavioral)
Outcomes
Primary Outcomes
Insomnia Severity Index
Time Frame: one month
One month after the intervention, experimental group mean for Insomnia Severity Index will be compared to control group mean Insomnia Severity Index. The Insomnia Severity Index is a self report brief screening tool with seven items that asks respondents to rate the nature and symptoms of their sleep problems and the degree to which insomnia interferes with daily functioning and overall distress created by sleep problems using a likert type scale Scores between 0-7 have no clinically significant insomnia. Scores between 8-14 have sub threshold insomnia. Scores between 15-21 have moderate clinical insomnia. Scores between 22-28 have severe clinical insomnia.
Secondary Outcomes
No secondary outcomes reported
Investigators
Suzanne Dickerson
Principal Investigator
State University of New York at Buffalo