Sleep Changes and Biomarkers After Breast Cancer Treatment
The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients
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 type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07341503 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Columbus, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.