NCT02613923

A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer

A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Sleep

Interventions

Type	Name	Description
BEHAVIORAL	GO! To Sleep	Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior
BEHAVIORAL	Sleep information	Participants will receive weekly emails on the health benefits of sleep for 6 weeks
PROCEDURE	Blood Draw	blood sample measured for stress and sleep markers
OTHER	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.
OTHER	Insomnia Severity Index (ISI)
OTHER	SF-12 quality of life survey

Timeline

• Start date: 2015-08-04
• Primary completion: 2017-03-23
• Completion: 2017-07-23
• First posted: 2015-11-25
• Last updated: 2019-05-09

Locations

1 site across 1 country: United States