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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Sleep

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Ability to access the internet and watch videos online. Valid email address. Self-reported sleep duration of 6 hours per night or less Exclusion Criteria: Previous diagnosis of cancer. Lack of ability to read and converse in English. Lack of ability to give informed consent.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GO! To Sleep<br>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. | Behavioral: GO! To Sleep<br>* Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior<br>Procedure: Blood Draw<br>* blood sample measured for stress and sleep markers<br>* Other names: biomarker measurement;Other: Pittsburgh Sleep Quality Index (PSQI)<br>* Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.<br>Other: Insomnia Severity Index (ISI)<br> <br> Other: SF-12 quality of life survey<br> <br> |
| Active Comparator: informational control<br>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. | Behavioral: Sleep information<br>* Participants will receive weekly emails on the health benefits of sleep for 6 weeks<br>Procedure: Blood Draw<br>* blood sample measured for stress and sleep markers<br>* Other names: biomarker measurement;Other: Pittsburgh Sleep Quality Index (PSQI)<br>* Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.<br>Other: Insomnia Severity Index (ISI)<br> <br> Other: SF-12 quality of life survey<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in change of SF-12 score from baseline to post-intervention between groups | 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 | Change from baseline to 6 months post intervention | 
| Correlation of joint changes in biomarker levels with PSQI and ISI | This study will correlate the joint changes in biomarker level with the changes in sleep quality and sleep duration | Change from baseline to 6 months post intervention | 
| Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups | Long term sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst) | Change from baseline to 6 months post intervention | 
| Difference in change in Insomnia Severity Index (ISI) score between groups | Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality | Change from baseline to 6 months post intervention | 
| Difference in change in sleep duration between groups | Sleep duration will be obtained by self-report from responses to the PSQI | Change from baseline to 6 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, GO! to sleep, sleep