Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-01-06 @ 4:03 PM
Study NCT ID:
NCT05522959
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2022-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardio-Oncology Rehabilitation Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2022-07-15', 'studyFirstSubmitQcDate': '2022-08-28', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Smoking Status', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Smoking assessment history questionnaire'}, {'measure': 'Moderate-Intensity Physical Activity Time', 'timeFrame': 'averaged over 7 days post-intervention', 'description': 'PiezoRx® will be worn by participants for 7 days with data used to assess moderate activity time (\\>100 steps per minute)'}, {'measure': 'Vigorous-intensity Physical Activity', 'timeFrame': 'averaged over 7 days post-intervention', 'description': 'PiezoRx® will be worn by participants for 7 days with data used to assess vigorous activity time (\\>120 steps per minute)'}, {'measure': 'Physical Activity Bouts per Day', 'timeFrame': 'averaged over 7 days post-intervention', 'description': 'PiezoRx® will be worn by participants for 7 days with data used to assess bouts of physical activity per day (greater than 10 minutes of moderate/vigorous activity)'}, {'measure': 'Total daily steps', 'timeFrame': 'averaged over 7 days post-intervention', 'description': 'PiezoRx® will be worn by participants for 7 days with data used to assess total daily steps'}, {'measure': 'Self-Reported Physical Activity', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Godin Leisure Time Physical Activity Questionnaire'}, {'measure': 'Diet quality', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Rapid Eating and Activity Assessment for Participants (REAP) questionnaire. Minimum score = 13, maximum score = 39, with a higher score indicating a higher diet quality.'}], 'primaryOutcomes': [{'measure': 'Cardiopulmonary Fitness', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'VO2peak assessed using cardiopulmonary exercise test'}], 'secondaryOutcomes': [{'measure': 'Visceral adipose tissue', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Measured only in a subset (n=30) of participants via 1.5T MRI.'}, {'measure': 'Left ventricular ejection fraction', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Measured only in a subset (n=30) of participants via 1.5T MRI.'}, {'measure': 'Native myocardial T1 time', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Measured only in a subset (n=30) of participants via 1.5T MRI.'}, {'measure': 'Left ventricular mass', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Measured only in a subset (n=30) of participants via 1.5T MRI.'}, {'measure': 'lipid profile', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Assessed via fasting blood draw'}, {'measure': 'Fasting glucose', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Assessed via fasting blood draw'}, {'measure': 'hemoglobin A1c', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Assessed via fasting blood draw'}, {'measure': 'Cancer-specific, health-related quality of life', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 108, with higher score representing better quality of life.'}, {'measure': 'Depressive symptoms', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Patient Health Questionnaire 9 scale. Minimum value = 0, maximum value = 27, where higher score represents more depressive symptoms.'}, {'measure': 'Psychosocial Stress', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Perceived Stress Scale (PSS). Minimum value = 0, maximum value = 56, where higher score represents more perceived stress.'}, {'measure': 'Cancer-related fatigue', 'timeFrame': 'post-intervention (16 weeks)', 'description': 'Fatigue sub-scale of the Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 52, with higher score representing less fatigue.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Rehabilitation', 'Cardio-oncology', 'Cardiometabolic Health', 'Cardiovascular Disease Risk'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female early-stage breast cancer survivors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of early-stage breast cancer (I-III)\n* Currently receiving or have completed adjuvant therapy (i.e. chemotherapy, surgery, radiation, targeted therapies)\n* Able to communicate in English\n\nExclusion Criteria:\n\n* Pregnancy\n* Metastatic disease (Stage IV)\n* Unable or unwilling to complete cardiopulmonary exercise test'}, 'identificationModule': {'nctId': 'NCT05522959', 'acronym': 'CORE', 'briefTitle': 'Cardio-Oncology Rehabilitation Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'A Single Arm Intervention Study to Assess the Role of Structured Cardio-Oncology Rehabilitation Exercise to Improve Cardiovascular Health in Early Stage Breast Cancer Survivors (CORE Study)', 'orgStudyIdInfo': {'id': '19-5080'}}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Paul Oh, MD', 'role': 'CONTACT', 'email': 'Paul.Oh@uhn.ca'}], 'facility': 'Toronto Rehabilitation Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Amy A Kirkham, PhD', 'role': 'CONTACT', 'email': 'amy.kirkham@utoronto.ca', 'phone': '(416) 946-4069\u202c\u202c'}], 'overallOfficials': [{'name': 'Amy Kirkham, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Toronto Rehabilitation Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Amy Kirkham', 'investigatorAffiliation': 'University of Toronto'}}}}