Clinical trial Recruiting at 1 site Observational Ages 18 and up

Sleep Changes and Biomarkers After Breast Cancer Treatment

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

Run by Ohio State University Comprehensive Cancer Center · NCT07341503 · Data updated 2026-11-12

This project will see how sleep patterns and stress-related biological markers change from treatment through survivorship in people with stage I–III hormone receptor–positive breast cancer.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorOhio State University Comprehensive Cancer Center
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Columbus, Ohio)
StatusRecruiting
StartedAugust 18, 2025
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJanuary 14, 2026
Trial IDNCT07341503 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with stage I–III hormone receptor–positive breast cancer who are post-primary surgery but before chemotherapy or radiation, able to consent, read English, and access their medical records.

Probably not a fit

People with stage IV/metastatic disease, those unable to consent or complete study tasks, non–English speakers, or patients with other active new malignancies are unlikely to be eligible or to gain direct benefit from the study’s findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows people with stage I–III hormone receptor–positive breast cancer from after primary surgery through survivorship to track sleep and related biomarkers. Participants wear a wrist actigraphy device, provide cheek swab, saliva, and hair samples, complete repeated surveys, and allow review of medical records. Researchers will analyze actigraphy-measured sleep duration and self-reported sleep quality over time and link these measures to sociodemographic, treatment, social support, and built environment factors, with attention to race, ethnicity, and underserved communities. The study will also examine associations between sleep and markers of biological aging, stress, and inflammation.

Why it matters

Potential benefit: If successful, the findings could help identify patients at risk for persistent sleep problems and elevated biological stress so clinicians can target supportive interventions during and after treatment.

How similar studies have gone: Prior observational studies have linked sleep disruption to inflammation and stress markers in cancer survivors, but few have longitudinally tracked actigraphy-measured sleep and biomarkers from treatment through survivorship across diverse communities.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio, United States
    Recruiting

Study contacts

  • Principal investigator: Electra Paskett, MSPH, PhD, FAACR — Ohio State University Comprehensive Cancer Center
  • Study coordinator: The Ohio State University Comprehensive Cancer Center
  • Email: OSUCCCClinicaltrials@osumc.edu
  • Phone: 800-293-5066

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.