Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-01 @ 2:17 PM
Study NCT ID:
NCT04224792
Status:
WITHDRAWN
Last Update Posted:
2022-06-09
First Post:
2020-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to pandemic, unable to see patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue symptoms', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Change in fatigue symptoms measured using the self-reported Fatigue Symptom Inventory (FSI) survey'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Change in physical activity measured using the self-reported International Physical Activity questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to determine whether an exercise program reduces fatigue and improves physical activity in thyroid cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18yrs of age with well-differentiated thyroid cancer and self-reported fatigue any time after initial treatment of thyroid cancer.\n* English speaking\n* Able to provide consent\n\nExclusion Criteria:\n\n* Pregnant\n* Medullary thyroid cancer\n* Anaplastic thyroid cancer\n* Physical limitations to perform exercise'}, 'identificationModule': {'nctId': 'NCT04224792', 'briefTitle': 'Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors', 'orgStudyIdInfo': {'id': '19-008397'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Center-based exercise group', 'description': 'Subjects will be enrolled into a center-based exercise program.', 'interventionNames': ['Other: Center-based exercise program']}, {'type': 'EXPERIMENTAL', 'label': 'Home-based exercise group', 'description': 'Subjects will be enrolled into a home-based exercise program.', 'interventionNames': ['Other: Home-based exercise program']}], 'interventions': [{'name': 'Center-based exercise program', 'type': 'OTHER', 'description': 'A routine individualized exercise prescription and supervised exercise sessions at a minimum of once per week for 11 weeks with an exercise prescription updated monthly.', 'armGroupLabels': ['Center-based exercise group']}, {'name': 'Home-based exercise program', 'type': 'OTHER', 'description': 'A one-time supervised exercise session with Cardiac Rehabilitation staff and a routine individualized exercise prescription for exercises to do at home. Additionally, weekly telephone followup calls by a clinical exercise physiologist for 11 weeks consisting of an exercise tip.', 'armGroupLabels': ['Home-based exercise group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Regina Castro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'M. Regina Castro', 'investigatorAffiliation': 'Mayo Clinic'}}}}