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

November 3, 2020 updated by: Danielle Mockensturm, University of Toledo Health Science Campus

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

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.

Study Overview

Status

Withdrawn

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Toledo, Ohio, United States, 43606
        • University of Toledo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ketki D Raina, PhD, OTR/L, University of Toledo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • UT BCS Sleep Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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