Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07341503

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Breast Carcinoma Breast Diseases Breast Neoplasms Hormone Receptor-Positive Breast Carcinoma Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Electra D. Paskett, MSPH, PhD, FAACR

CONTACT

[email protected]

614-293-3917

Electra D. Paskett, MSPH, PhD, FAACR

PRINCIPAL_INVESTIGATOR

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • * 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

Exclusion criteria

  • * Stage IV or metastatic breast cancer
  • Not cognitively able to provide informed consent
  • Not willing to provide informed consent

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

  1. Total sleep duration

    Time frame: 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.

  2. Self-reported sleep quality (PROMIS)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • American Association for Cancer Research

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.