Brief Behavioral Treatment for Insomnia in Cancer Survivors

Study Overview
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Brief Summary
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The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.

Detailed Description
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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).

Official Title
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Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors

Conditions
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Chronic Insomnia

Intervention / Treatment
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* Behavioral: Brief behavioral treatment for insomnia
* Behavioral: Healthy Eating Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral: Brief behavioral treatment for insomnia<br>Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls. | Behavioral: Brief behavioral treatment for insomnia<br>* Brief Behavioral Treatment for Insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month for primary outcome followed by 3 month 12 month follow-up visits.<br>|
| Active Comparator: Behavioral: Healthy eating control<br>Healthy eating control involves a 45 minute individual session with two follow up phone calls. | Behavioral: Healthy Eating Control<br>* Healthy eating control involves healthy eating content with 1 month for primary outcome followed by 3 month and 12 month follow-up visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | 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. | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Survivors, Brief Behavioral Treatment, Older Adults, Attention Control, Intervention