A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Difference in change in Insomnia Severity Index (ISI) score between groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Previous diagnosis of cancer.
- •Lack of ability to read and converse in English.
- •Lack of ability to give informed consent.
研究组 & 干预措施
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.
干预措施: GO! To Sleep (Behavioral)
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.
干预措施: Blood Draw (Procedure)
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.
干预措施: Pittsburgh Sleep Quality Index (PSQI) (Other)
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.
干预措施: Insomnia Severity Index (ISI) (Other)
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.
干预措施: SF-12 quality of life survey (Other)
informational control
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.
干预措施: Sleep information (Behavioral)
informational control
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.
干预措施: Blood Draw (Procedure)
informational control
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.
干预措施: Pittsburgh Sleep Quality Index (PSQI) (Other)
informational control
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.
干预措施: Insomnia Severity Index (ISI) (Other)
informational control
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.
干预措施: SF-12 quality of life survey (Other)
结局指标
主要结局
Difference in change in Insomnia Severity Index (ISI) score between groups
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- 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)