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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04232319
• Other study ID #: UT BCS Sleep Study
• Status: Withdrawn
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: July 2020

Study information

• Verified date: November 2020
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sleep Hygiene

Intervention

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.

Locations

Country	Name	City	State
United States	University of Toledo	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sleep Quality (Pittsburgh Sleep Quality Index)	Measures the quality of sleep	Baseline to 7 weeks
Secondary	Change in Ecological Momentary Assessment of Sleep Quality	Ecological Momentary Assessments via Smartphone App	Baseline to 7 weeks
Secondary	Change in Actigraphy-based measure of Sleep	Actigraphy-based measure of Sleep	Baseline to 7 weeks
Secondary	Change in knowledge of Sleep Hygiene Strategies (Sleep Hygiene Index)	Measure individual's knowledge of Sleep Hygiene Strategies	Baseline to 7 weeks
Secondary	Change in Ecological Momentary Assessment of Sleep Quantity	Ecological Momentary Assessments via Smartphone App	Baseline to 7 weeks