Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-30 @ 1:55 AM
Study NCT ID:
NCT01173861
Status:
COMPLETED
Last Update Posted:
2012-07-13
First Post:
2010-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Cancer Center Based Physical Activity Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-12', 'studyFirstSubmitDate': '2010-05-25', 'studyFirstSubmitQcDate': '2010-07-30', 'lastUpdatePostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of a cancer center based physical activity intervention for increasing physical activity in breast cancer survivors.', 'timeFrame': '8 weeks', 'description': 'The primary outcome is to examine the effectiveness of a cancer center based physical activity intervention on increasing physical activity as measured by step counts on a pedometer.'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of a cancer center based physical activity counseling intervention on increasing quality of life in breast cancer survivors.', 'timeFrame': '8 weeks', 'description': 'The secondary outcome is to examine the effectiveness of a cancer center based physical activity counseling intervention on improving quality of life in breast cancer survivors.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Quality of Life', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'Purpose: Examine the effectiveness of cancer center-based physical activity counseling on physical activity rates and quality of life in breast cancer survivors.\n\nHypothesis: Participants in the intervention group will indicate greater step counts and quality of life at the end of the intervention compared to the control group'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of breast cancer within the last 5 years\n* Over the age of 18 years\n* female\n\nExclusion Criteria:\n\n* Non-ambulatory\n* Poor cognitive function\n* Contraindications for exercise as determined by the PAR-Q'}, 'identificationModule': {'nctId': 'NCT01173861', 'briefTitle': 'Effectiveness of a Cancer Center Based Physical Activity Intervention', 'organization': {'class': 'OTHER', 'fullName': 'East Carolina University'}, 'officialTitle': 'Effectiveness of a Cancer Center Based Physical Activity Intervention', 'orgStudyIdInfo': {'id': 'IRB 09-0887'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical activity counseling', 'description': 'Group receives face-to-face physical activity counseling.', 'interventionNames': ['Behavioral: Physical activity counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual', 'description': 'Group receives physical activity manual.', 'interventionNames': ['Behavioral: Physical activity counseling']}], 'interventions': [{'name': 'Physical activity counseling', 'type': 'BEHAVIORAL', 'description': '20-30 minutes of face-to-face physical activity counseling using motivational interviewing followed by 3 20 minute telephone counseling sessions.', 'armGroupLabels': ['Manual', 'Physical activity counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Leo Jenkins Cancer Center', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}], 'overallOfficials': [{'name': 'Kristina H Karvinen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Carolina University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Carolina University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kristina Karvinen', 'investigatorAffiliation': 'East Carolina University'}}}}