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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04232319
Enrollment
0
Registered
2020-01-18
Start date
2020-01-15
Completion date
2020-07-31
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Sleep Hygiene

Keywords

Breast cancer, sleep, intervention, Sleep, Intervention, Self-management

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.

Interventions

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.

Sponsors

University of Toledo Health Science Campus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Sleep Quality (Pittsburgh Sleep Quality Index)Baseline to 7 weeksMeasures the quality of sleep

Secondary

MeasureTime frameDescription
Change in Ecological Momentary Assessment of Sleep QualityBaseline to 7 weeksEcological Momentary Assessments via Smartphone App
Change in Actigraphy-based measure of SleepBaseline to 7 weeksActigraphy-based measure of Sleep
Change in knowledge of Sleep Hygiene Strategies (Sleep Hygiene Index)Baseline to 7 weeksMeasure individual's knowledge of Sleep Hygiene Strategies
Change in Ecological Momentary Assessment of Sleep QuantityBaseline to 7 weeksEcological Momentary Assessments via Smartphone App

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026