Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-03-03 @ 3:54 PM
Study NCT ID:
NCT05988892
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2023-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Physical Activity in Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in physical functioning using Short Physical Performance Battery', 'timeFrame': 'Baseline; 12 weeks', 'description': 'Change in physical functioning based on improvement in endurance, strength, and balance assessed using Short Physical Performance Battery (SPPB) pre- and post-12-week exercise intervention.'}, {'measure': 'Change in Quality of Life (QOL) using Patient-Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': 'Baseline; 12 weeks', 'description': 'QOL evaluated based on physical functioning and fatigue, assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) pre- and post-12-week exercise intervention.'}, {'measure': 'Change in satisfaction using a 5-point Likert scale', 'timeFrame': 'Baseline; 12 weeks', 'description': 'Satisfaction assessed using a 5-point Likert scale following 12-week exercise intervention and participant-reporting likelihood of recommending program.'}, {'measure': 'Rate of adherence to program based on participation in virtual exercise sessions', 'timeFrame': 'Baseline; 12 weeks', 'description': 'Adherence evaluated based on participation in virtual exercise sessions during 12-week exercise intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rural', 'Physical Activity'], 'conditions': ['Cancer', 'Hematopoietic and Lymphatic System Neoplasm', 'Malignant Solid Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if increasing physical activity (PA) will increase physical functioning, as measured by cardiovascular endurance, muscular strength, and balance in underserved adult cancer survivors \\> 60 years of age and/or those of any age residing at a rural address. Also, to determine if increasing PA will increase quality of life (QOL), as measured by physical functioning and fatigue, in underserved cancer survivors \\>60 years of age and/or those of any age residing at a rural address.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult, cancer survivors (no active disease) at Mayo Clinic Health System (MCHS) in Northwest Wisconsin (NWWI), Southwest Wisconsin (SWWI), Southeast Minnesota (SEMN), or Southwest Minnesota (SWMN)\n* Any stage cancer\n* Age ≥18 years residing at a rural address (as defined by Rural America, census.gov)\n* Completed active treatment of surgery, (neo)adjuvant chemotherapy, and/or (neo) adjuvant radiation. Patients receiving adjuvant endocrine therapy, targeted therapy, or immunotherapy therapies are eligible.\n* Ownership of a computer/tablet/smartphone with internet access.\n* Willingness to create a google account and maintain the account for use of the Fitbit\n* Willingness and ability to attend study visits.\n* Must be able to complete semi-tandem (10 seconds), side-by-side tandem \\[10 seconds and short physical performance batters(SPPB)\\] Score of 6 or greater to qualify for virtual exercise.\n* Must be ambulatory without the use of assisted device(s).\n\nExclusion Criteria:\n\n* Receiving surgery, (neo)adjuvant chemotherapy, (neo) adjuvant radiation, palliative treatment\n* Are already performing \\>150 minutes/week of moderate activity or 75 min/week of vigorous physical activity\n* Cancer-free for greater than 5 years\n* Unable to complete weekly interventions/exercise due to traveling or unable to be active for more than 7 consecutive days.'}, 'identificationModule': {'nctId': 'NCT05988892', 'briefTitle': 'A Study of Physical Activity in Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Improving Physical Activity in Rural Cancer Survivors', 'orgStudyIdInfo': {'id': '23-001462'}, 'secondaryIdInfos': [{'id': 'NCI-2023-05387', 'type': 'OTHER', 'domain': 'Clinical Trials Reporting Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community Oncology patients entering cancer survivorship', 'description': 'Patients participate in a virtual cancer rehabilitation program with weekly virtual visits by a cancer exercise specialist who provides a personalized synchronous exercise plan and receive bi-weekly phone calls/emails over 12 weeks. Patents also wear a Fitbit on study.', 'interventionNames': ['Behavioral: Physical Activity']}], 'interventions': [{'name': 'Physical Activity', 'type': 'BEHAVIORAL', 'description': 'Use Exercise to increase physical activity (PA), as measured by cardiovascular endurance, muscular strength, and balance in underserved cancer survivors \\>60 years of age and/or those of any age residing at a rural address and to increase quality of life (QOL), as measured by physical functioning and fatigue, in underserved cancer survivors \\>60 years of age and/or those of any age residing at a rural address.', 'armGroupLabels': ['Community Oncology patients entering cancer survivorship']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56007', 'city': 'Albert Lea', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Health System in Albert Lea', 'geoPoint': {'lat': 43.64801, 'lon': -93.36827}}, {'zip': '56001', 'city': 'Mankato', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Health System-Mankato', 'geoPoint': {'lat': 44.15906, 'lon': -94.00915}}, {'zip': '54701', 'city': 'Eau Claire', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mayo Clinic Health System-Eau Claire Clinic', 'geoPoint': {'lat': 44.81135, 'lon': -91.49849}}, {'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Mayo Clinic Health System-Franciscan Healthcare', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}], 'overallOfficials': [{'name': 'Kaye T. Sturz, APRN, CNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic Health System in Eau Claire'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}