Recruiting

Observational Study

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07341503

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

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

Study ID

NCT07341503

Start date

Aug 18, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Electra D. Paskett, MSPH, PhD, FAACR

614-293-3917Electra.Paskett@osumc.edu

Principal Investigator:

Electra D. Paskett, MSPH, PhD, FAACR

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Jan 14, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-01-14.