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

NCT04232319 | Withdrawn

• 1 other identifier: UT BCS Sleep Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Sleep Hygiene

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Quality (Pittsburgh Sleep Quality Index)

  Measures the quality of sleep

  Baseline to 7 weeks

Secondary Outcomes (4)

• Change in Ecological Momentary Assessment of Sleep Quality

  Baseline to 7 weeks

• Change in Actigraphy-based measure of Sleep

  Baseline to 7 weeks

• Change in knowledge of Sleep Hygiene Strategies (Sleep Hygiene Index)

  Baseline to 7 weeks

• Change in Ecological Momentary Assessment of Sleep Quantity

  Baseline to 7 weeks

Study Arms (1)

Sleep Hygiene Training

EXPERIMENTAL

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

Interventions

Sleep Hygiene Training BEHAVIORAL

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.

Sleep Hygiene Training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead

Study Sites (1)

University of Toledo

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Sleep Hygiene

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Health Behavior; Behavior

Study Officials

• Ketki D Raina, PhD, OTR/L

  University of Toledo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: January 18, 2020
• Study Start: January 15, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 26, 2024

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)