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

Primary Purpose

Breast Cancer, Sleep Hygiene

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Hygiene Training
Sponsored by
University of Toledo Health Science Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, sleep, intervention, Sleep, Intervention, Self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Toledo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sleep Hygiene Training

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Sleep Quality (Pittsburgh Sleep Quality Index)
Measures the quality of sleep

Secondary Outcome Measures

Change in Ecological Momentary Assessment of Sleep Quality
Ecological Momentary Assessments via Smartphone App
Change in Actigraphy-based measure of Sleep
Actigraphy-based measure of Sleep
Change in knowledge of Sleep Hygiene Strategies (Sleep Hygiene Index)
Measure individual's knowledge of Sleep Hygiene Strategies
Change in Ecological Momentary Assessment of Sleep Quantity
Ecological Momentary Assessments via Smartphone App

Full Information

First Posted
November 8, 2019
Last Updated
November 3, 2020
Sponsor
University of Toledo Health Science Campus
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1. Study Identification

Unique Protocol Identification Number
NCT04232319
Brief Title
Feasibility and Effectiveness of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors
Official Title
Feasibility of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Due to COVID this study was never started.
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toledo Health Science Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Sleep Hygiene
Keywords
Breast cancer, sleep, intervention, Sleep, Intervention, Self-management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Hygiene Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Sleep Quality (Pittsburgh Sleep Quality Index)
Description
Measures the quality of sleep
Time Frame
Baseline to 7 weeks
Secondary Outcome Measure Information:
Title
Change in Ecological Momentary Assessment of Sleep Quality
Description
Ecological Momentary Assessments via Smartphone App
Time Frame
Baseline to 7 weeks
Title
Change in Actigraphy-based measure of Sleep
Description
Actigraphy-based measure of Sleep
Time Frame
Baseline to 7 weeks
Title
Change in knowledge of Sleep Hygiene Strategies (Sleep Hygiene Index)
Description
Measure individual's knowledge of Sleep Hygiene Strategies
Time Frame
Baseline to 7 weeks
Title
Change in Ecological Momentary Assessment of Sleep Quantity
Description
Ecological Momentary Assessments via Smartphone App
Time Frame
Baseline to 7 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ketki D Raina, PhD, OTR/L
Organizational Affiliation
University of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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