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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | August 18, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT07341503 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.
-
Blended e-Health Program to Help Women with Breast or Gynecologic Cancer Manage Fear of Cancer Progression
This trial tests a blended online and group program to see if it helps women with breast or gynecologic cancer feel less fear that their cancer could grow or spread.
-
Personalized Exercise Plan for Breast Cancer Survivors on Chemotherapy
This trial tests whether adding a guided exercise program to a healthy-lifestyle education plan helps breast cancer patients undergoing chemotherapy maintain fitness, heart health, and quality of life.
-
5-strain probiotic to prevent bone loss during aromatase inhibitor therapy
This trial will try a 5-strain probiotic called WBF-038 to see if it prevents bone loss in people with early-stage hormone receptor–positive breast cancer who are starting aromatase inhibitor therapy.
-
Ultra‑short whole-breast radiation with lumpectomy cavity boost for stage I–III breast cancer
This trial will test whether a very short course of whole‑breast radiation with a boost to the lumpectomy cavity works well and is safe for women age 40 and older with stage I–III breast cancer who had breast‑conserving surgery.
-
Hypofractionated radiotherapy for non-metastatic breast cancer treatment
This study is testing if giving a shorter course of radiation therapy before or after surgery can help women with non-metastatic breast cancer while causing fewer severe side effects.
-
Using acupuncture and acupressure to reduce joint pain in Black women with early-stage breast cancer
This study is testing whether acupuncture and virtual acupressure can help reduce joint pain for Black women with early-stage breast cancer who are taking hormone therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.