About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
* 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
Disqualifiers
* Stage IV or metastatic breast cancer
Not cognitively able to provide informed consent
Not willing to provide informed consent
Trial population
Patients diagnosed with stage I to stage III breast cancer, being followed at the OSUCCC.
Trial design
Cohort
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
Trial outcomes
Primary outcomes
Total sleep duration
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)
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).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University Comprehensive Cancer Center
Lead sponsor
American Association for Cancer Research
Collaborator