The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

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 volunteers

Qualifiers

* 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Observational1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, an average of 9 months
2

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).

Time frame
Through study completion, an average of 9 months

Secondary outcomes

Other outcomes

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