- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04232319
Feasibility and Effectiveness of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors
Feasibility of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Toledo, Ohio, United States, 43606
- University of Toledo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sleep Quality (Pittsburgh Sleep Quality Index)
Time Frame: Baseline to 7 weeks
|
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
Time Frame: Baseline to 7 weeks
|
Ecological Momentary Assessments via Smartphone App
|
Baseline to 7 weeks
|
Change in Actigraphy-based measure of Sleep
Time Frame: Baseline to 7 weeks
|
Actigraphy-based measure of Sleep
|
Baseline to 7 weeks
|
Change in knowledge of Sleep Hygiene Strategies (Sleep Hygiene Index)
Time Frame: Baseline to 7 weeks
|
Measure individual's knowledge of Sleep Hygiene Strategies
|
Baseline to 7 weeks
|
Change in Ecological Momentary Assessment of Sleep Quantity
Time Frame: Baseline to 7 weeks
|
Ecological Momentary Assessments via Smartphone App
|
Baseline to 7 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ketki D Raina, PhD, OTR/L, University of Toledo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UT BCS Sleep Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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