A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Difference in change in Insomnia Severity Index (ISI) score between groups
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Difference in change in Insomnia Severity Index (ISI) score between groups
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Difference in change of SF-12 score from baseline to post-intervention between groups(Change from baseline to 6 months post intervention)
- Correlation of joint changes in biomarker levels with PSQI and ISI(Change from baseline to 6 months post intervention)
- Difference in change in Insomnia Severity Index (ISI) score between groups(Change from baseline to 6 months post intervention)
- Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups(Change from baseline to 6 months post intervention)
- Difference in change in sleep duration between groups(Change from baseline to 6 months post intervention)