A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
NCT ID: NCT02613923
Last Updated: 2019-05-09
Study Results
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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COMPLETED
NA
17 participants
INTERVENTIONAL
2015-08-04
2017-07-23
Brief Summary
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Participants are asked to participate in this research study because they have been identified as being at higher than average risk of developing breast cancer.
The purpose of this study is to compare women who get a sleep intervention to women who do not get a sleep intervention. This study team will compare these two groups of women to see if the sleep intervention improves their sleep and if it lowers markers of inflammation that have been associated with an increased risk of breast cancer.
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Detailed Description
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Objective 2: To test the effectiveness of improvements in sleep quality and/or duration due to the GO! To Sleep program on biomarkers of inflammation in women at high risk of breast cancer.
Objective 3: To evaluate the effectiveness of improvements in health-related quality of life after the GO! To Sleep in women at high risk of breast cancer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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GO! To Sleep
Participants in the intervention group will be provided with a code and website address to participate in this program. This program includes reminder emails and is 6 weeks in duration. Participants will be given a blood draw to measure biomarkers.
GO! To Sleep
Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior
Blood Draw
blood sample measured for stress and sleep markers
Pittsburgh Sleep Quality Index (PSQI)
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Insomnia Severity Index (ISI)
SF-12 quality of life survey
informational control
Participants in the control group will receive weekly emails with sleep information and the health benefits of sleep for 6 weeks.Participants will be given a blood draw to measure biomarkers.
Sleep information
Participants will receive weekly emails on the health benefits of sleep for 6 weeks
Blood Draw
blood sample measured for stress and sleep markers
Pittsburgh Sleep Quality Index (PSQI)
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Insomnia Severity Index (ISI)
SF-12 quality of life survey
Interventions
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GO! To Sleep
Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior
Sleep information
Participants will receive weekly emails on the health benefits of sleep for 6 weeks
Blood Draw
blood sample measured for stress and sleep markers
Pittsburgh Sleep Quality Index (PSQI)
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Insomnia Severity Index (ISI)
SF-12 quality of life survey
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Carry deleterious mutations in the BRCA1, BRCA2, PTEN, TP53, STK11, or CDH1 genes
* Previous diagnosis of lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH) or atypical lobular hyperplasia (ALH)
* Lifetime risk of 20% or greater as calculated by the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool or the Tyrer-Cuzick IBIS Risk Assessment Tool
2. Ability to access the internet and watch videos online.
3. Valid email address.
4. Self-reported sleep duration of 6 hours per night or less
Exclusion Criteria
2. Lack of ability to read and converse in English.
3. Lack of ability to give informed consent.
21 Years
FEMALE
Yes
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Cheryl Thompson, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Locations
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University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE6114
Identifier Type: -
Identifier Source: org_study_id
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