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

NCT ID: NCT07341503

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-18

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

I. Characterize longitudinal trends in sleep among BC patients from treatment through survivorship, overall and by race, ethnicity, and underserved communities (rural, urban, Appalachian) using actigraphy-assessed sleep duration (Aim 1a), and self-reported sleep quality (Aim 1b).

II. Identify risk factors (sociodemographic, clinical treatment, social support, built environment) associated with sleep duration and sleep quality over time.

III. Assess how sleep duration and quality affect premature biological aging, stress, and inflammatory markers in BC patients from treatment to survivorship, overall and by race, ethnicity, and community.

OUTLINE: This is an observational study.

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.

Conditions

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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 Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Other Intervention Names

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Non-Interventional Observational Study Noninterventional (Observational) Study

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Association for Cancer Research

OTHER

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Electra Paskett

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Electra Paskett, MSPH, PhD, FAACR

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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The Ohio State University Comprehensive Cancer Center

Role: CONTACT

800-293-5066

Facility Contacts

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Electra D. Paskett, MSPH, PhD, FAACR

Role: primary

614-293-3917

Other Identifiers

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NCI-2025-02354

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-24386

Identifier Type: -

Identifier Source: org_study_id

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