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

NCT ID: NCT04232319

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Sleep Hygiene

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sleep Hygiene Training

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Toledo Health Science Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ketki D Raina, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Toledo

Locations

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University of Toledo

Toledo, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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UT BCS Sleep Study

Identifier Type: -

Identifier Source: org_study_id

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