Feasibility and Effectiveness of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors

Study Overview
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Brief Summary
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The proposed research will assess the feasibility and preliminary effectiveness of a Sleep Hygiene Program for Breast Cancer Survivors. Participants will complete assessments related to sleep issues, participate in a Sleep Hygiene Program, and complete another assessment post-intervention.

Official Title
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Feasibility of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors

Conditions
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Breast Cancer, Sleep Hygiene

Intervention / Treatment
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* Behavioral: Sleep Hygiene Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with breast cancer and not currently receiving active treatment in the form of chemotherapy or radiation therapy, at least 18 years of age, women score > 5 on the Pittsburgh Sleep Quality Index Participant has a smartphone that operates on the Android or Apple platform Participant is able to use the Ecological Momentary Assessment application in the morning functional English fluency and literacy Exclusion Criteria: self-reported history of diagnosis of co-morbidities that have been associated with poor sleep and fatigue: chronic insomnia, chronic fatigue syndrome, unstable heart, lung, or neuromuscular disease, insulin-dependent diabetes, sleep apnea, chronic oral steroid therapy, and night-shift employment. Currently taking a pharmacological sleep aide

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Hygiene Training<br>The intervention will be delivered online by an occupational therapist. The intervention consists of 3 weekly sessions; each session will be 30-45 minutes long. The focus of the intervention is to teach breast cancer survivors sleep hygiene strategies to improve their sleep. | Behavioral: Sleep Hygiene Training<br>* The intervention will last approximately 45 minutes, and will be provided once/week for 3 weeks. The intervention is delivered live using web-cameras (e.g., Microsoft Zoom). Registered and licensed occupational therapists will deliver the intervention. Each week, the interventionist will guide the participant through a workbook to provide knowledge regarding sleep hygiene strategies and examples on how to apply these strategies to improve sleep quality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Quality (Pittsburgh Sleep Quality Index) | Measures the quality of sleep | Baseline to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ecological Momentary Assessment of Sleep Quality | Ecological Momentary Assessments via Smartphone App | Baseline to 7 weeks | 
| Change in Actigraphy-based measure of Sleep | Actigraphy-based measure of Sleep | Baseline to 7 weeks | 
| Change in knowledge of Sleep Hygiene Strategies (Sleep Hygiene Index) | Measure individual's knowledge of Sleep Hygiene Strategies | Baseline to 7 weeks | 
| Change in Ecological Momentary Assessment of Sleep Quantity | Ecological Momentary Assessments via Smartphone App | Baseline to 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, sleep, intervention, Sleep, Intervention, Self-management