Anatomic Stage I Breast Cancer AJCC v8NCT07341503
The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients
An observational study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Non-Interventional Study
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with stage I to stage III breast cancer, being followed at the OSUCCC.
Who may be able to join
- * 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)
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- Able to speak, understand and read English
- Cognitively able to complete the study requirements
- Ability to access medical records from treating hospital
Who cannot join
- * Stage IV or metastatic breast cancer
- Not cognitively able to provide informed consent
- Not willing to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Electra D. Paskett, MSPH, PhD, FAACR, 614-293-3917, Electra.Paskett@osumc.edu
Electra D. Paskett, MSPH, PhD, FAACR
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- 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
- Being tested
- Non-Interventional Study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep duration
Will report descriptive statistics of the sample characteristics using counts and percentages or means and standard deviations. Actigraphy from the sleep watch (GENEActiv device) will be scored and analyzed using validated algorithms within the Activeinsights software (Activinsights, UK). Daily and weekly summaries of sleep statistics will be averaged to generate person-level data for analysis at each time point. a paired t-test to compare T1 sleep duration (pre-treatment) to T3 (treatment completion) sleep duration using SAS PROC POWER.
Measured: Through study completion, an average of 9 months
Self-reported sleep quality (PROMIS)
Sleep quality (as measured by the PROMIS) will be considered as a continuous variable and categorized into 'poor quality' if patients have a score of >= 5 and 'good quality' if < 5 points. Locally weighted scatterplot smoothing will be used to estimate a smooth trend through the sleep data points (sleep duration, sleep quality). Generalized linear mixed models will be used to examine changes in sleep over time (treatment through survivorship).
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start18 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Association for Cancer Research
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra Paskett, MSPH, PhD, FAACR, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341503
- Sponsor's protocol ID
- OSU-24386
- Other IDs
- NCI-2025-02354
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07341503
- Acronym / sponsor ID
- OSU-24386
- 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 type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Association for Cancer Research
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with stage I to stage III breast cancer, being followed at the OSUCCC.
Key inclusion criteria (9 listed)
- * Age >= 18 years old at time of breast cancer diagnosis
Key exclusion criteria (3 listed)
- * Stage IV or metastatic breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational |
Primary outcome
Total sleep duration
Time frame: Through study completion, an average of 9 months
Will report descriptive statistics of the sample characteristics using counts and percentages or means and standard deviations. Actigraphy from the sleep watch (GENEActiv device) will be scored and analyzed using validated algorithms within the Activeinsights software (Activinsights, UK). Daily and weekly summaries of sleep statistics will be averaged to generate person-level data for analysis at each time point. a paired t-test to compare T1 sleep duration (pre-treatment) to T3 (treatment completion) sleep duration using SAS PROC POWER.
Self-reported sleep quality (PROMIS)
Time frame: Through study completion, an average of 9 months
Sleep quality (as measured by the PROMIS) will be considered as a continuous variable and categorized into 'poor quality' if patients have a score of >= 5 and 'good quality' if < 5 points. Locally weighted scatterplot smoothing will be used to estimate a smooth trend through the sleep data points (sleep duration, sleep quality). Generalized linear mixed models will be used to examine changes in sleep over time (treatment through survivorship).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Electra Paskett, MSPH, PhD, FAACR principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sleep duration (time frame: Through study completion, an average of 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.