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A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
Participants are asked to participate in a research study of the effect of a sleep intervention on improving sleep habits and reducing their risk of breast cancer. 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.
Objective 1: To test the effectiveness of the GO! To Sleep program at improving the sleep duration and sleep quality in women at high risk of breast cancer. 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.
Age
21 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Start Date
August 4, 2015
Primary Completion Date
March 23, 2017
Completion Date
July 23, 2017
Last Updated
May 9, 2019
17
ACTUAL participants
GO! To Sleep
BEHAVIORAL
Sleep information
BEHAVIORAL
Blood Draw
PROCEDURE
Pittsburgh Sleep Quality Index (PSQI)
OTHER
Insomnia Severity Index (ISI)
OTHER
SF-12 quality of life survey
OTHER
Lead Sponsor
Case Comprehensive Cancer Center
NCT05372640
NCT04704661
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