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

Not Applicable

Completed

• Conditions: Breast Cancer; Sleep
• Interventions: Behavioral: GO! To Sleep; Behavioral: Sleep information; Procedure: Blood Draw; Other: Pittsburgh Sleep Quality Index (PSQI); Other: Insomnia Severity Index (ISI); Other: SF-12 quality of life survey

• Registration Number: NCT02613923
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 2015-08-04
• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Primary Completion: 2017-03-23
• Study Completion: 2017-07-23
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-07
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

1. Women at high risk of breast cancer due to one or more of the following:

   • 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

1. Previous diagnosis of cancer.
2. Lack of ability to read and converse in English.
3. Lack of ability to give informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
informational control	SF-12 quality of life survey	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.
informational control	Blood Draw	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.
GO! To Sleep	Insomnia Severity Index (ISI)	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	Pittsburgh Sleep Quality Index (PSQI)	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	SF-12 quality of life survey	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.
informational control	Pittsburgh Sleep Quality Index (PSQI)	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.
GO! To Sleep	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.
informational control	Sleep information	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.
informational control	Insomnia Severity Index (ISI)	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.
GO! To Sleep	Blood Draw	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.

Primary Outcome Measures

Name	Time	Method
Difference in change in Insomnia Severity Index (ISI) score between groups	Change from baseline to post intervention, around 8 weeks after baseline	Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Difference in change in sleep duration between groups	Change from baseline to post intervention, around 8 weeks after baseline	Sleep duration will be obtained by self-report from responses to the PSQI
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups	Change from baseline to post intervention, around 8 weeks after baseline	Sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)

Secondary Outcome Measures

Name	Time	Method
Difference in change of SF-12 score from baseline to post-intervention between groups	Change from baseline to 6 months post intervention	The effectiveness of changing health-related quality of life after the GO! To Sleep program will he measured with the self-reported survey SF-12
Correlation of joint changes in biomarker levels with PSQI and ISI	Change from baseline to 6 months post intervention	This study will correlate the joint changes in biomarker level with the changes in sleep quality and sleep duration
Difference in change in Insomnia Severity Index (ISI) score between groups	Change from baseline to 6 months post intervention	Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups	Change from baseline to 6 months post intervention	Long term sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
Difference in change in sleep duration between groups	Change from baseline to 6 months post intervention	Sleep duration will be obtained by self-report from responses to the PSQI

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States