The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total sleep duration
研究概览
简要总结
This study is being done to learn more about breast cancer patients' experiences with sleep changes during cancer treatment, identify possible reasons for poor sleep quality, and to find out how stress, social support, and living environment affect sleep.
详细描述
PRIMARY OBJECTIVES:
I. Characterize longitudinal trends in sleep among BC patients from treatment through survivorship, overall and by race, ethnicity, and underserved communities (rural, urban, Appalachian) using actigraphy-assessed sleep duration (Aim 1a), and self-reported sleep quality (Aim 1b).
II. Identify risk factors (sociodemographic, clinical treatment, social support, built environment) associated with sleep duration and sleep quality over time.
III. Assess how sleep duration and quality affect premature biological aging, stress, and inflammatory markers in BC patients from treatment to survivorship, overall and by race, ethnicity, and community.
OUTLINE: This is an observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Age >= 18 years old at time of breast cancer diagnosis
- •Stage I to III breast cancer diagnosis
- •Hormone receptor positive breast cancers
- •Post primary surgery, before chemotherapy/radiation therapy begins
- •No known evidence of breast cancer recurrence (local or distant) or second, primary cancer
- •No prior history of new other malignancy since their breast cancer diagnosis (other than non-melanoma skin cancer)
- •Able to speak, understand and read English
- •Cognitively able to complete the study requirements
- •Ability to access medical records from treating hospital
排除标准
- •* Stage IV or metastatic breast cancer
- •Not cognitively able to provide informed consent
- •Not willing to provide informed consent
研究组 & 干预措施
Observational
Patients undergo collection of cheek swab, saliva, and hair samples, wear a wrist sleep tracking device, and complete surveys throughout the study. Additionally, patients have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Total sleep duration
时间窗: Through study completion, an average of 9 months
Will report descriptive statistics of the sample characteristics using counts and percentages or means and standard deviations. Actigraphy from the sleep watch (GENEActiv device) will be scored and analyzed using validated algorithms within the Activeinsights software (Activinsights, UK). Daily and weekly summaries of sleep statistics will be averaged to generate person-level data for analysis at each time point. a paired t-test to compare T1 sleep duration (pre-treatment) to T3 (treatment completion) sleep duration using SAS PROC POWER.
Self-reported sleep quality (PROMIS)
时间窗: Through study completion, an average of 9 months
Sleep quality (as measured by the PROMIS) will be considered as a continuous variable and categorized into 'poor quality' if patients have a score of \>= 5 and 'good quality' if \< 5 points. Locally weighted scatterplot smoothing will be used to estimate a smooth trend through the sleep data points (sleep duration, sleep quality). Generalized linear mixed models will be used to examine changes in sleep over time (treatment through survivorship).
次要结局
未报告次要终点
研究者
Electra Paskett
Principal Investigator
Ohio State University Comprehensive Cancer Center