Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT04232319
NCT04232319WithdrawnNot Applicable

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

University of Toledo Health Science Campus2 sites in 1 countryStarted: January 15, 2020Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
2
Primary Endpoint
Change in Sleep Quality (Pittsburgh Sleep Quality Index)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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,
  • •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

Outcomes

Primary Outcomes

Change in Sleep Quality (Pittsburgh Sleep Quality Index)

Time Frame: Baseline to 7 weeks

Measures the quality of sleep

Secondary Outcomes

  • 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 Quality(Baseline to 7 weeks)
  • Change in Ecological Momentary Assessment of Sleep Quantity(Baseline to 7 weeks)

Investigators

Sponsor
University of Toledo Health Science Campus
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Completed
Not Applicable
A pilot study of a sleep hygiene education program in Parkinson?s disease sufferers: effect on carer well-beingNervous System DiseasesParkinson's disease
ISRCTN11720842Manchester Mental Health and Social Care Trust (UK)30
Completed
Not Applicable
School-based Sleep Hygiene Education Program for Adolescents in JapaSleep disorder
JPRN-UMIN000027587Department of Public Health and Epidemiology, Faculty of Medicine, Oita University.3,000
Not yet recruiting
Not Applicable
the effects of Sleep hygiene education and music on sleep quality in clients with MSMultiple sclerosis
IRCT20211023052853N1Iran University of Medical Sciences50
Completed
Not Applicable
Sleep Hygiene Education in Individuals With Fibromyalgia; Sleep Quality, Pain and DepressionFibromyalgia
NCT06276855Cumhuriyet University70
Completed
Not Applicable
Studying the effect of Sleep Hygiene Education on sleep quality of adult women with comparing two groups of control & intervention.Sleep quality.Sleep disorder
IRCT2016090429694N1Vice chancellor for research of Babol University of Medical Sciences70