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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cheek swab, saliva, and hair samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total sleep duration', 'timeFrame': 'Through study completion, an average of 9 months', 'description': '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.'}, {'measure': 'Self-reported sleep quality (PROMIS)', 'timeFrame': 'Through study completion, an average of 9 months', 'description': "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)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. 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).\n\nII. Identify risk factors (sociodemographic, clinical treatment, social support, built environment) associated with sleep duration and sleep quality over time.\n\nIII. 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.\n\nOUTLINE: This is an observational study.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with stage I to stage III breast cancer, being followed at the OSUCCC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\* Age \\>= 18 years old at time of breast cancer diagnosis\n\n * Stage I to III breast cancer diagnosis\n * Hormone receptor positive breast cancers\n * Post primary surgery, before chemotherapy/radiation therapy begins\n * No known evidence of breast cancer recurrence (local or distant) or second, primary cancer\n * No prior history of new other malignancy since their breast cancer diagnosis (other than non-melanoma skin cancer)\n * Able to speak, understand and read English\n * Cognitively able to complete the study requirements\n * Ability to access medical records from treating hospital\n\nExclusion Criteria:\n\n* \\* Stage IV or metastatic breast cancer\n\n * Not cognitively able to provide informed consent\n * Not willing to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07341503', 'briefTitle': 'The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'The Sleep After Breast Cancer (ABC) Study - Examining Sleep Changes and Biomarkers Among Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'OSU-24386'}, 'secondaryIdInfos': [{'id': 'NCI-2025-02354', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': '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.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'otherNames': ['Non-Interventional Observational Study', 'Noninterventional (Observational) Study'], 'description': 'Non-interventional study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Electra D. Paskett, MSPH, PhD, FAACR', 'role': 'CONTACT', 'email': 'Electra.Paskett@osumc.edu', 'phone': '614-293-3917'}, {'name': 'Electra D. Paskett, MSPH, PhD, FAACR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'The Ohio State University Comprehensive Cancer Center', 'role': 'CONTACT', 'email': 'OSUCCCClinicaltrials@osumc.edu', 'phone': '800-293-5066'}], 'overallOfficials': [{'name': 'Electra Paskett, MSPH, PhD, FAACR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Association for Cancer Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Electra Paskett', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}