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

The Ohio State University

Status: Enrolling

Conditions: Anatomic Stage III Breast Cancer AJCC v8; Hormone Receptor-Positive Breast Carcinoma; Anatomic Stage II Breast Cancer AJCC v8; Breast Carcinoma; Anatomic Stage I Breast Cancer AJCC v8

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT07341503

OSU-24386

NCI-2025-02354 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Observational

Description:

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.

Treatment:

Other: Non-Interventional Study