Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 7:07 AM
Study NCT ID:
NCT00379106
Status:
COMPLETED
Last Update Posted:
2010-01-07
First Post:
2006-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arm Function and Quality of Life Following Mastectomy.
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-06', 'studyFirstSubmitDate': '2006-09-19', 'studyFirstSubmitQcDate': '2006-09-20', 'lastUpdatePostDateStruct': {'date': '2010-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm Function and Quality of Life Following Mastectomy', 'timeFrame': 'Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Supportive', 'Mastectomy', 'Quality of Life', 'Arm Function'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To measure arm function and quality of life of mastectomy patients.', 'detailedDescription': 'Treatment: Randomized to one of two treatment arms. Group One: Basic active exercise program at home. Group Two: Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises. Range of Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year. Patients will complete demographic form, functional questionnaire, and QOL questionnaire.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been referred from UNMH to CRTC for further treatment following mastectomy/lumpectomy surgery.\n\nExclusion Criteria:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00379106', 'briefTitle': 'Arm Function and Quality of Life Following Mastectomy.', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Arm Function and Quality of Life Following Mastectomy.', 'orgStudyIdInfo': {'id': '1002C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group1', 'interventionNames': ['Procedure: Arm exercises.']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'interventionNames': ['Procedure: Arm Exercises']}], 'interventions': [{'name': 'Arm exercises.', 'type': 'PROCEDURE', 'description': 'Basic active exercise program at home.', 'armGroupLabels': ['Group1']}, {'name': 'Arm Exercises', 'type': 'PROCEDURE', 'description': 'Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87130', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Kathy Dieruf', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kathy Dieruf, MD; Principal Investigator', 'oldOrganization': 'Universtiy of New Mexico - CRTC'}}}}