Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment

Study Overview
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Brief Summary
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The primary goal of the proposed study is to examine a cognitive behavioral intervention for insomnia (CBTI) in women after breast cancer treatment. Chronic Insomnia is a highly prevalent and distressing symptom in cancer patients. CBTI is considered the treatment of choice for chronic primary insomnia. Few studies have been conducted in cancer survivors to evaluate the effect of CBTI on sleep and clinically relevant outcomes.

Detailed Description
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The overall goals of this study are to: 1) test standard 4-component CBTI in patients with breast cancer post-treatment, 2) gather data on the feasibility of the methods, and 3) determine effects of the intervention on quality of life (QOL) and daily functioning. Sixty women after completion of primary breast cancer treatment, 21-65 years of age, who meet the criteria for chronic insomnia will be recruited from two Western U.S. Cancer Centers. Participants will be randomized to one of two treatment conditions (CBTI or behavioral placebo treatment). Both groups will receive six in-office and phone sessions. The control group will receive the same amount of individualized attention. Sleep efficiency and component measures (e.g., sleep onset latency, minutes awake after sleep onset) and quality of life and component measures of daily functioning will be assess pre and post-intervention, and at 3- and 6-month follow up visits. It is hypothesized that women receiving CBTI treatment will demonstrate greater increase in sleep efficiency (time in bed compared with time asleep) and will self-report greater improvements in QOL and daily functioning compared to those receiving a behavioral placebo treatment at the conclusion of the intervention and at 3- to 6-month follow-ups. Established instruments include the Insomnia Severity Index, Morin Sleep Diary, Dysfunctional Beliefs and Attitudes about Sleep-16, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30, Attentional Function Index, Revised Piper Fatigue Scale, and Hospital Anxiety and Depression Scale. Subjective data will be corroborated with actigraphy. Results may inform development of clinical guidelines for insomnia management after cancer treatment. The proposed study associated with this K23 award relates to the Health People 2010 goal of improving quality of life of individuals of all ages, and the cancer focus area goal of reducing illness and disability caused by cancer.

Official Title
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Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI)
* Behavioral: Behavioral Placebo Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 to 65 years of age inclusive 1-36 months after radiation or chemotherapy for non-metastatic breast cancer and on a stable dose of anti-estrogen agent and medications for hot flashes Meets diagnostic criteria for chronic, secondary insomnia Speak and write English Exclusion Criteria: Presence of a serious unstable physical illness other than cancer Presence of dementia, major depression, psychosis or other serious psychiatric disorder Presence of a sleep disorder other than insomnia Unstable doses of psychotropic medications (excluding hypnotics), opioids, anit-endocrine medications, or use of high dose steroids Current evening/night shift employment

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Behavioral Placebo Therapy<br>Behavioral Placebo Treatment | Behavioral: Behavioral Placebo Treatment<br>* Six 15-30 minute in-person or phone sessions that begin with a review of the sleep diary, a general discussion of treatment progress and tabulation of sleep parameters.<br>|
| Active Comparator: Cognitive Behavioral Therapy<br>Cognitive Behavioral Therapy for Insomnia (CBTI) | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI)<br>* Six 15-30 minute in-person or phone sessions that incorporate cognitive, behavioral and psycho-educational techniques focused on modifying the perpetuating factors that maintain insomnia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep efficiency |  | baseline, pre and post intervention, 3-months, 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep latency, total sleep time, quality of life, fatigue |  | baseline, pre and post intervention, 3-months, 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer survivors, insomnia, quality of life