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

NCT07341503 | Recruiting

• 2 other identifiers: OSU-24386NCI-2025-02354
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Through study completion, an average of 9 months

• 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).

  Through study completion, an average of 9 months

Study Arms (1)

Observational

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.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with stage I to stage III breast cancer, being followed at the OSUCCC.

You may qualify if:

• \* 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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• American Association for Cancer Research: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cheek swab, saliva, and hair samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Electra Paskett, MSPH, PhD, FAACR

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: January 14, 2026
• Study Start: August 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-09

Locations

US (1)