Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:14 AM
Study NCT ID:
NCT07341503
Status:
RECRUITING
Last Update Posted:
2026-01-14
First Post:
2025-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-02354 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |