Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-27 @ 7:06 PM
Study NCT ID:
NCT02765269
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2016-04-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intelligent Pain Management System for Assessing Pain in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '021-69691540', 'title': 'Gang Ding', 'organization': 'Xinhua Translational Institute for Cancer Pain, Shanghai'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'No adverse events were assessed throughout the study.', 'eventGroups': [{'id': 'EG000', 'title': 'IPMS Group', 'description': 'Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.\n\nIntelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': "The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.", 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IPMS Group', 'description': 'Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.\n\nIntelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly.'}, {'id': 'OG001', 'title': 'Control Group', 'description': "The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy."}], 'classes': [{'categories': [{'measurements': [{'value': '2.37', 'spread': '0.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'The primary objective is to demonstrate that this mobile application is feasible by observing the numbers of daily pain assessment among patients.', 'unitOfMeasure': 'pain assessments per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IPMS Group', 'description': 'Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.\n\nIntelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly.'}, {'id': 'OG001', 'title': 'Control Group', 'description': "The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy."}], 'classes': [{'categories': [{'measurements': [{'value': '2.20', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '2.95', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Numerical rating scale allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be". Higher values means worse outcomes. The investigators will compare average pain score assessed by numerical rating scale at the end of the trial period.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Users' Satisfaction (Questionnaire)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IPMS Group', 'description': 'Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.\n\nIntelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly.'}, {'id': 'OG001', 'title': 'Control Group', 'description': "The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy."}], 'classes': [{'title': 'very much like IPMS', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'like IMPS', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'dislike IPMS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'Patients will be asked to complete a questionnaire after patients use it for 2 weeks.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Karnofsky Performance Score Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IPMS Group', 'description': 'Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.\n\nIntelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly.'}, {'id': 'OG001', 'title': 'Control Group', 'description': "The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy."}], 'classes': [{'categories': [{'measurements': [{'value': '68.80', 'spread': '7.23', 'groupId': 'OG000'}, {'value': '56.19', 'spread': '7.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'The Karnofsky performance score runs from 100 to 0, where 100 is "perfect" health and 0 is death. Higher values represent better outcomes.The investigators will compare average score between trial group and control group.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IPMS Group', 'description': 'Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.\n\nIntelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly.'}, {'id': 'FG001', 'title': 'Control Group', 'description': "The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IPMS Group', 'description': 'Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.\n\nIntelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly.'}, {'id': 'BG001', 'title': 'Control Group', 'description': "The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-23', 'studyFirstSubmitDate': '2016-04-25', 'resultsFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2016-05-04', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-29', 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients', 'timeFrame': '2 weeks', 'description': 'The primary objective is to demonstrate that this mobile application is feasible by observing the numbers of daily pain assessment among patients.'}], 'secondaryOutcomes': [{'measure': 'Pain Management', 'timeFrame': '2 weeks', 'description': 'Numerical rating scale allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be". Higher values means worse outcomes. The investigators will compare average pain score assessed by numerical rating scale at the end of the trial period.'}, {'measure': "Users' Satisfaction (Questionnaire)", 'timeFrame': '2 weeks', 'description': 'Patients will be asked to complete a questionnaire after patients use it for 2 weeks.'}, {'measure': 'Karnofsky Performance Score Evaluation', 'timeFrame': '2 weeks', 'description': 'The Karnofsky performance score runs from 100 to 0, where 100 is "perfect" health and 0 is death. Higher values represent better outcomes.The investigators will compare average score between trial group and control group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer pain', 'mobile applications'], 'conditions': ['Pain', 'Neoplasms']}, 'referencesModule': {'references': [{'pmid': '28743681', 'type': 'DERIVED', 'citation': 'Sun Y, Jiang F, Gu JJ, Wang YK, Hua H, Li J, Cheng Z, Liao Z, Huang Q, Hu W, Ding G. Development and Testing of an Intelligent Pain Management System (IPMS) on Mobile Phones Through a Randomized Trial Among Chinese Cancer Patients: A New Approach in Cancer Pain Management. JMIR Mhealth Uhealth. 2017 Jul 25;5(7):e108. doi: 10.2196/mhealth.7178.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether the Intelligent Pain Management System (IPMS) could make recording and interfering pain timely among cancer patients with pain. The system's usability, feasibility, compliance, and satisfaction will also be assessed.", 'detailedDescription': "Research indicate that over one-third of cancer patients experienced cancer pain, which is known as a major reason leading to lower quality of life of the patients.In this present study, the investigators aim to design, develop, and test the feasibility of a low cost, conveniently implemented mobile application to facilitate real-time pain recording and timely intervention among Chinese cancer patients with pain. This system evaluate real-time pain and Karnofsky Performance Status（KPS）scores for quality of life, and to generate an action plan to visit the physician or to adjust pain medication dosage when the pain threshold is reached. The investigators study is to test this system's effectiveness."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the patient was able to read Chinese and use smart phones;\n* the patient was diagnosed with cancer and has self-reported cancer pain within a month prior to the study;\n* the patient was being seen on a regular basis by the oncology team;\n* the patient was under standard analgesia treatments;\n* the patient was estimated to have over 3 months survival time.\n\nExclusion Criteria:\n\n* the patients who self-reported to have severe cognitive impairments or major comorbid illnesses that would interfere with pain assessment.'}, 'identificationModule': {'nctId': 'NCT02765269', 'briefTitle': 'Intelligent Pain Management System for Assessing Pain in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Translational Institute for Cancer Pain, Shanghai'}, 'officialTitle': 'Development and Testing of an Intelligent Pain Management System (IPMS) for Chinese Patients With Cancer', 'orgStudyIdInfo': {'id': 'XHTICP 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPMS group', 'description': 'Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.', 'interventionNames': ['Device: Intelligent Pain Management System']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy."}], 'interventions': [{'name': 'Intelligent Pain Management System', 'type': 'DEVICE', 'otherNames': ['IPMS'], 'description': 'A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly.', 'armGroupLabels': ['IPMS group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Xinhua Translational Institute for Cancer Pain, Shanghai', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Gang Ding', 'role': 'STUDY_CHAIR', 'affiliation': 'Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine, Chongming Branch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Translational Institute for Cancer Pain, Shanghai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}