The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- Total sleep duration [Time frame: Through study completion, an average of 9 months]
- Self-reported sleep quality (PROMIS) [Time frame: Through study completion, an average of 9 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Ohio State University Comprehensive Cancer Center — Columbus
Identifiers
NCT: NCT07341503 · OSU-24386 · NCI-2025-02354