Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-03-01 @ 4:46 PM
Study NCT ID:
NCT02715856
Status:
TERMINATED
Last Update Posted:
2022-10-13
First Post:
2016-03-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rlsatcher@mdanderson.org', 'phone': '(713) 794-5242', 'title': 'Dr. Robert Satcher, Associate Professor, Orthopaedic Oncology', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Due to software issues and depletion of funds the protocol was terminated early and the participants did not complete assessments per protocol at given point, no data collected.'}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Phase I (Standard Follow up, Physical Activity Measurement)', 'description': 'Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.\n\nPhysical Activity Measurement: Undergo physical activity measurement\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nStandard Follow-Up Care: Undergo standard follow-up care\n\nSurvey Administration: Ancillary studies', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase II (Mobile Surveillance)', 'description': 'Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.\n\nMonitoring Device: Undergo surgical wound and physical activity monitoring\n\nPhysical Activity Measurement: Undergo physical activity measurement\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nStandard Follow-Up Care: Undergo standard follow-up care\n\nSurvey Administration: Ancillary studies', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inter-Rater Agreement on the Physician Assessed Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I (Standard Follow up, Physical Activity Measurement)', 'description': 'Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.\n\nPhysical Activity Measurement: Undergo physical activity measurement\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nStandard Follow-Up Care: Undergo standard follow-up care\n\nSurvey Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Phase II (Mobile Surveillance)', 'description': 'Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.\n\nMonitoring Device: Undergo surgical wound and physical activity monitoring\n\nPhysical Activity Measurement: Undergo physical activity measurement\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nStandard Follow-Up Care: Undergo standard follow-up care\n\nSurvey Administration: Ancillary studies'}], 'timeFrame': '7 months', 'description': 'Inter-rater agreement on the physician assessed score defined as less than 10% difference between the Musculoskeletal Tumor Society (MSTS) scores evaluated using video vs. face-to-face follow ups.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to software issues and depletion of funds the protocol was terminated early and the participants did not complete assessments per protocol at given point, no data collected.'}, {'type': 'SECONDARY', 'title': 'Completion of Follow-Up Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I (Standard Follow up, Physical Activity Measurement)', 'description': 'Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.\n\nPhysical Activity Measurement: Undergo physical activity measurement\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nStandard Follow-Up Care: Undergo standard follow-up care\n\nSurvey Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Phase II (Mobile Surveillance)', 'description': 'Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.\n\nMonitoring Device: Undergo surgical wound and physical activity monitoring\n\nPhysical Activity Measurement: Undergo physical activity measurement\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nStandard Follow-Up Care: Undergo standard follow-up care\n\nSurvey Administration: Ancillary studies'}], 'timeFrame': 'Up to 25 weeks', 'description': 'Participant considered having completed the follow-up assessments if the three outcomes are documented for the 2-, 6-, 12, and 24-week evaluations. Follow-up assessment information taken from Musculoskeletal Tumor Society Scores (MSTS), Timed "Up and Go" test (TUG), and Patient Reported Outcomes Measurement Information System (PROMIS).', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to software issues and depletion of funds the protocol was terminated early and the participants did not complete assessments per protocol at given point, no data collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase I (Control)', 'description': 'Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.\n\nPhysical Activity Measurement: Undergo physical activity measurement\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nStandard Follow-Up Care: Undergo standard follow-up care\n\nSurvey Administration: Ancillary studies'}, {'id': 'FG001', 'title': 'Phase II (Mobile Surveillance)', 'description': 'Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.\n\nMonitoring Device: Undergo surgical wound and physical activity monitoring\n\nPhysical Activity Measurement: Undergo physical activity measurement\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nStandard Follow-Up Care: Undergo standard follow-up care\n\nSurvey Administration: Ancillary studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '52'}]}], 'dropWithdraws': [{'type': 'Software Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Non- Compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '40'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase I (Standard Follow up, Physical Activity Measurement)', 'description': 'Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.\n\nPhysical Activity Measurement: Undergo physical activity measurement\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nStandard Follow-Up Care: Undergo standard follow-up care\n\nSurvey Administration: Ancillary studies'}, {'id': 'BG001', 'title': 'Phase II (Mobile Surveillance)', 'description': 'Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.\n\nMonitoring Device: Undergo surgical wound and physical activity monitoring\n\nPhysical Activity Measurement: Undergo physical activity measurement\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies\n\nStandard Follow-Up Care: Undergo standard follow-up care\n\nSurvey Administration: Ancillary studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66', 'spread': '9', 'groupId': 'BG000'}, {'value': '59', 'spread': '13', 'groupId': 'BG001'}, {'value': '61', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-21', 'size': 356696, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-13T18:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'whyStopped': 'Due to software issues and depletion of funds the protocol was terminated early', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2016-03-17', 'resultsFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-10', 'studyFirstPostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inter-Rater Agreement on the Physician Assessed Score', 'timeFrame': '7 months', 'description': 'Inter-rater agreement on the physician assessed score defined as less than 10% difference between the Musculoskeletal Tumor Society (MSTS) scores evaluated using video vs. face-to-face follow ups.'}], 'secondaryOutcomes': [{'measure': 'Completion of Follow-Up Assessments', 'timeFrame': 'Up to 25 weeks', 'description': 'Participant considered having completed the follow-up assessments if the three outcomes are documented for the 2-, 6-, 12, and 24-week evaluations. Follow-up assessment information taken from Musculoskeletal Tumor Society Scores (MSTS), Timed "Up and Go" test (TUG), and Patient Reported Outcomes Measurement Information System (PROMIS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone metastases', 'Intramedullary nailing surgery', 'IM', 'Physical tasks', 'Surveys', 'Questionnaires', 'Smartphone', 'Tablet', 'Telemedicine', 'Telemonitoring'], 'conditions': ['Bone Metastases', 'Cancer Survivor', 'Metastatic Malignant Neoplasm in the Bone']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This randomized pilot trial studies telemonitoring after surgery to preserve limb function in optimizing mobility in cancer survivors with cancer spread to the bone. The use of mobile devices for telemonitoring may improve the delivery of cost-effective, high-quality, standardized surveillance of cancer survivors.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To develop and evaluate the feasibility of a method that enhances surveillance in cancer survivors by using mobile devices in addition to face-to-face visits following surgery for bone metastases.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate how well the face-to-face follow-up format can be adapted to using mobile devices for remote surveillance.\n\nII. Limited efficacy testing of the remote surveillance program. III. To obtain information on acceptability of the mobile surveillance format by patients and clinicians.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I (CONTROL): Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.\n\nGROUP II (MOBILE SURVEILLANCE): Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.\n\nAfter completion of study, patients are followed up at 24-25 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been scheduled for an intramedullary nailing (IM) surgery with the department of Orthopaedic Oncology at University of Texas (UT) MD Anderson Cancer Center\n* Are able to read and write English 3) Are 18 years or older\n* Are willing and able to use a smartphone or tablet comfortably\n* Have access to mobile hot spot, wireless internet, and/or cellular service\n* Must have a caregiver or assistance at home who can assist with collecting physical therapy (PT) measures\n\nExclusion:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT02715856', 'briefTitle': 'Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Using Telemonitoring to Optimize the Mobility of Cancer Survivors With Skeletal Metastases After Surgery to Preserve Limb Function', 'orgStudyIdInfo': {'id': '2015-0966'}, 'secondaryIdInfos': [{'id': 'NCI-2016-00544', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2015-0966', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': '2015-00051255-Y1', 'type': 'OTHER_GRANT', 'domain': 'Cancer Survivorship Research Seed Money Grant'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I (standard follow up, physical activity measurement)', 'description': 'Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.', 'interventionNames': ['Other: Physical Activity Measurement', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Procedure: Standard Follow-Up Care', 'Other: Survey Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group II (mobile surveillance)', 'description': 'Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.', 'interventionNames': ['Other: Monitoring Device', 'Other: Physical Activity Measurement', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Procedure: Standard Follow-Up Care', 'Other: Survey Administration']}], 'interventions': [{'name': 'Monitoring Device', 'type': 'OTHER', 'otherNames': ['Monitor'], 'description': 'Undergo surgical wound and physical activity monitoring', 'armGroupLabels': ['Group II (mobile surveillance)']}, {'name': 'Physical Activity Measurement', 'type': 'OTHER', 'otherNames': ['Activity'], 'description': 'Undergo physical activity measurement', 'armGroupLabels': ['Group I (standard follow up, physical activity measurement)', 'Group II (mobile surveillance)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (standard follow up, physical activity measurement)', 'Group II (mobile surveillance)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (standard follow up, physical activity measurement)', 'Group II (mobile surveillance)']}, {'name': 'Standard Follow-Up Care', 'type': 'PROCEDURE', 'description': 'Undergo standard follow-up care', 'armGroupLabels': ['Group I (standard follow up, physical activity measurement)', 'Group II (mobile surveillance)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (standard follow up, physical activity measurement)', 'Group II (mobile surveillance)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Robert L Satcher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}