Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-02-27 @ 3:48 PM
Study NCT ID:
NCT01900418
Status:
COMPLETED
Last Update Posted:
2016-08-08
First Post:
2013-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}, {'id': 'C034430', 'term': 'methyl hydroxyethyl cellulose'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-05', 'studyFirstSubmitDate': '2013-07-11', 'studyFirstSubmitQcDate': '2013-07-15', 'lastUpdatePostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-reported fatigue', 'timeFrame': '6 weeks', 'description': 'A valid and reliable Visual Analog Scale will be used to assess fatigue.'}, {'measure': 'Self-reported joint stiffness', 'timeFrame': '6 week', 'description': 'A valid and reliable Visual Analog Scale will be used to assess joint stiffness.'}, {'measure': 'Pain', 'timeFrame': '6 weeks', 'description': 'The Brief Pain Inventory Short Form will be used to assess pain. It is a valid and reliable instrument that has been used in other studies of breast cancer survivors.'}, {'measure': 'Lower extremity pain and function', 'timeFrame': '6 weeks', 'description': 'The Western Ontario McMaster Universities Arthritis Index will be used to assess hip and knee pain and function.'}, {'measure': 'Quality of life', 'timeFrame': '6 weeks', 'description': 'Functional Assessment of Cancer Therapy-General (FACT-G)'}, {'measure': 'Beliefs about engaging in exercise', 'timeFrame': '6 weeks', 'description': 'Expectations for Exercise (OEE) scale'}, {'measure': 'Self-efficacy to manage joint pain', 'timeFrame': '6 weeks', 'description': 'Arthritis Self-Efficacy Scale (ASE)'}, {'measure': 'Engagement in Physical Activity', 'timeFrame': '6 weeks', 'description': 'Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire 2011'}, {'measure': 'Helplessness', 'timeFrame': '6 weeks', 'description': 'Rheumatology Attitudes Index (RAI)'}, {'measure': 'Adverse event', 'timeFrame': '6 weeks', 'description': 'Self-report of any adverse events will be used to monitor safety.'}, {'measure': 'Feasibility', 'timeFrame': '6 weeks', 'description': 'Achievement of 100% recruitment of the enrollment target and 80% completion will indicate program feasibility.'}, {'measure': 'Tolerability', 'timeFrame': '6 weeks', 'description': 'Self-report of engaging in any walking level during the 6 week period by 50% of participants will indicate tolerability.'}], 'primaryOutcomes': [{'measure': 'Self-reported joint pain', 'timeFrame': '6 weeks', 'description': 'A valid and reliable 10cm Visual Analog Scale will be used to assess self-reported joint pain. This scale has been used in numerous trials.'}], 'secondaryOutcomes': [{'measure': 'Self-reported walking', 'timeFrame': '6 weeks', 'description': 'This will be measured by the number of days walked per week and the number of minutes per walk.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer', 'aromatase inhibitors', 'physical activity', 'joint pain'], 'conditions': ['Joint Pain', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This "proof-of-concept" study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation\'s Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Taking an aromatase inhibitor as adjuvant treatment for State I, II, or II breast cancer for at least 4 weeks\n* Experiencing more than mild joint pain/symptoms\n* 21 or older\n* have permission from physician to engage in moderate intensity physical activity\n\nExclusion Criteria:\n\n* Undergoing chemotherapy and/or radiation therapy at any time during the study period\n* Scheduled for major surgery during the study period\n* Presently engaged in high levels of physical activity on a daily basis\n* Less than 21 years of age\n* Unable to walk or engage in moderate intensity physical activity'}, 'identificationModule': {'nctId': 'NCT01900418', 'briefTitle': 'Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy', 'orgStudyIdInfo': {'id': '13-2321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Walking', 'description': 'Walk with Ease', 'interventionNames': ['Behavioral: Walk with Ease']}, {'type': 'NO_INTERVENTION', 'label': 'Wait list control', 'description': 'Wait list control receiving the active intervention 6 weeks later.'}], 'interventions': [{'name': 'Walk with Ease', 'type': 'BEHAVIORAL', 'description': 'An evidence-based walking program', 'armGroupLabels': ['Walking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Leigh F Callahan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mary Link Briggs Distinguished Professor of Medicine', 'investigatorFullName': 'Leigh F Callahan, PhD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}