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

Not Applicable

Withdrawn

• Conditions: Sleep Hygiene; Breast Cancer
• Interventions: Behavioral: Sleep Hygiene Training

• Registration Number: NCT04232319
• Lead Sponsor: University of Toledo Health Science Campus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-08
• Study Start: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Status Verified: 2020-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. diagnosed with breast cancer and not currently receiving active treatment in the form of chemotherapy or radiation therapy,
2. at least 18 years of age,
3. women
4. score > 5 on the Pittsburgh Sleep Quality Index
5. Participant has a smartphone that operates on the Android or Apple platform
6. Participant is able to use the Ecological Momentary Assessment application in the morning
7. functional English fluency and literacy

Exclusion Criteria

1. 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.
2. Currently taking a pharmacological sleep aide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sleep Hygiene Training	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.

Primary Outcome Measures

Name	Time	Method
Change in Sleep Quality (Pittsburgh Sleep Quality Index)	Baseline to 7 weeks	Measures the quality of sleep

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Toledo; 🇺🇸 Toledo, Ohio, United States