Feasibility and Effectiveness of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT04232319|
Recruitment Status : Withdrawn (Due to COVID this study was never started.)
First Posted : January 18, 2020
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Sleep Hygiene||Behavioral: Sleep Hygiene Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors|
|Actual Study Start Date :||January 15, 2020|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Sleep Hygiene Training
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
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.
- Change in Sleep Quality (Pittsburgh Sleep Quality Index) [ Time Frame: Baseline to 7 weeks ]Measures the quality of sleep
- Change in Ecological Momentary Assessment of Sleep Quality [ Time Frame: Baseline to 7 weeks ]Ecological Momentary Assessments via Smartphone App
- Change in Actigraphy-based measure of Sleep [ Time Frame: Baseline to 7 weeks ]Actigraphy-based measure of Sleep
- Change in knowledge of Sleep Hygiene Strategies (Sleep Hygiene Index) [ Time Frame: Baseline to 7 weeks ]Measure individual's knowledge of Sleep Hygiene Strategies
- Change in Ecological Momentary Assessment of Sleep Quantity [ Time Frame: Baseline to 7 weeks ]Ecological Momentary Assessments via Smartphone App
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232319
|United States, Ohio|
|University of Toledo|
|Toledo, Ohio, United States, 43606|
|Principal Investigator:||Ketki D Raina, PhD, OTR/L||The University of Toledo|