Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT04342260
Status:
COMPLETED
Last Update Posted:
2025-02-20
First Post:
2020-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'agentry@email.unc.edu', 'phone': '(336) 655-7743', 'title': 'Amanda Gentry', 'organization': 'University of North Carolina Lineberger Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'This study protocol does not require Adverse Event reporting, only all-cause mortality up to12 months were reported.', 'description': 'This study protocol does not require Adverse Event reporting, only unanticipated problems involving risks to study subjects or others (UPIRSO) refer to any incident, experience report is required.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Monitoring', 'description': "Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.\n\nActive Monitoring: The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Passive Monitoring', 'description': 'Clinicians will not receive any symptom alerts.\n\nPassive Monitoring: Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Life at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Monitoring', 'description': "Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.\n\nActive Monitoring: The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported."}, {'id': 'OG001', 'title': 'Passive Monitoring', 'description': 'Clinicians will not receive any symptom alerts.\n\nPassive Monitoring: Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.97', 'spread': '17.06', 'groupId': 'OG000'}, {'value': '84.02', 'spread': '16.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months post-discharge', 'description': 'Quality of Life (QOL) will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) version 3.0 and reported as a score on a scale from 0 to 100 with a higher score being a better QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population.'}, {'type': 'PRIMARY', 'title': 'Lung Cancer Specific Quality of Life at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Monitoring', 'description': "Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.\n\nActive Monitoring: The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported."}, {'id': 'OG001', 'title': 'Passive Monitoring', 'description': 'Clinicians will not receive any symptom alerts.\n\nPassive Monitoring: Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.'}], 'classes': [{'title': 'Pain in chest', 'categories': [{'measurements': [{'value': '15.48', 'spread': '27.94', 'groupId': 'OG000'}, {'value': '9.52', 'spread': '17.82', 'groupId': 'OG001'}]}]}, {'title': 'Pain in arm or shoulder', 'categories': [{'measurements': [{'value': '21.43', 'spread': '26', 'groupId': 'OG000'}, {'value': '10.71', 'spread': '22.32', 'groupId': 'OG001'}]}]}, {'title': 'Pain in other parts', 'categories': [{'measurements': [{'value': '30.95', 'spread': '32.62', 'groupId': 'OG000'}, {'value': '21.43', 'spread': '28.99', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral neuropathy', 'categories': [{'measurements': [{'value': '26.19', 'spread': '34.38', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '20.96', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '20.09', 'spread': '22', 'groupId': 'OG000'}, {'value': '23.81', 'spread': '24.51', 'groupId': 'OG001'}]}]}, {'title': 'Coughing', 'categories': [{'measurements': [{'value': '22.62', 'spread': '24.09', 'groupId': 'OG000'}, {'value': '30.95', 'spread': '22.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months post-discharge', 'description': 'Lung cancer specific Quality of Life will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Lung Cancer-13 (EORTC QLQ-LC13) supplement and reported as a score from 0 to 100 with a higher score being worse symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population.'}, {'type': 'PRIMARY', 'title': 'PRO Symptom Monitoring Surveys Completed at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Monitoring', 'description': "Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.\n\nActive Monitoring: The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported."}, {'id': 'OG001', 'title': 'Passive Monitoring', 'description': 'Clinicians will not receive any symptom alerts.\n\nPassive Monitoring: Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.1', 'groupId': 'OG000'}, {'value': '50.30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months post-discharge', 'description': 'The percentage of subjects who completed symptom surveys out of delivered symptom surveys.', 'unitOfMeasure': 'percentage of participants completed', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population.'}, {'type': 'PRIMARY', 'title': 'PRO Symptom Monitoring Alerts Resulting in a Clinician Response at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Monitoring', 'description': "Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.\n\nActive Monitoring: The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported."}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months post-discharge', 'description': 'The percentage of survey alerts that generate a clinician response will be calculated.', 'unitOfMeasure': 'percentage of participants received aler', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'PRIMARY', 'title': 'Barriers and Facilitators of PRO Monitoring After Thoracic Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interview Subset', 'description': 'Subset of participant who completed semi-structured interviews.'}], 'classes': [{'title': 'Symptoms and physical functioning during surgical recovery were barriers to ePRO completion.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Access to required technology was a barrier to completing web-based ePROs for a few participants.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Participants reported ease of completing the ePRO assessments.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Patients preferred engagement on ePRO participation with the surgical care team.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Participants reported irrelevant or repeated ePRO monitoring questions.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Participants reported a lack of clarity on ePRO assessment integration with routine clinical care.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Participants reported increased awareness of their symptoms and recovery with ePRO use.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'assessed at 2 months through 2 years post-discharge', 'description': 'Barriers and facilitators of PRO monitoring after thoracic surgery will be assessed using qualitative methods. A subset of patients and caregivers participated in semi-structured interviews. Thematic analysis was used to identify determinants.', 'unitOfMeasure': 'Themes', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset of patients who completed semi-structured interviews included those from both the active and passive monitoring arms and were combined for thematic analysis. No calculations across or between groups were performed for qualitative analyses. Numbers represented here are the number of themes derived from the interviews.'}, {'type': 'SECONDARY', 'title': 'Readmission at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Monitoring', 'description': "Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.\n\nActive Monitoring: The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported."}, {'id': 'OG001', 'title': 'Passive Monitoring', 'description': 'Clinicians will not receive any symptom alerts.\n\nPassive Monitoring: Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post-discharge', 'description': 'Readmission rates after thoracic surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Overall Survival at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Monitoring', 'description': "Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.\n\nActive Monitoring: The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported."}, {'id': 'OG001', 'title': 'Passive Monitoring', 'description': 'Clinicians will not receive any symptom alerts.\n\nPassive Monitoring: Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months post-discharge', 'description': 'Survival will be compared between arms using Cox proportional hazards regression model.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Monitoring', 'description': "Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.\n\nActive Monitoring: The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported."}, {'id': 'FG001', 'title': 'Passive Monitoring', 'description': 'Clinicians will not receive any symptom alerts.\n\nPassive Monitoring: Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'Started ePROs', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'Completed ePROs', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}], 'recruitmentDetails': 'Patients undergoing major thoracic surgery within the Multidisciplinary Thoracic Surgery Program at the University of North Carolina at Chapel Hill between April 2020 and June 2021 who met the inclusion criteria were invited to participate in this study.', 'preAssignmentDetails': 'Eligible patients who enrolled were assigned to study arms at the time of enrollment in a 1:1 ratio using block randomization with blocks of 20 participants (patients).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Monitoring', 'description': "Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.\n\nActive Monitoring: The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported."}, {'id': 'BG001', 'title': 'Passive Monitoring', 'description': 'Clinicians will not receive any symptom alerts.\n\nPassive Monitoring: Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '18-65 years', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': '>65 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'number of participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-05', 'size': 958555, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-23T14:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2020-03-24', 'resultsFirstSubmitDate': '2024-10-09', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-29', 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life at 12 Months', 'timeFrame': '12 months post-discharge', 'description': 'Quality of Life (QOL) will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) version 3.0 and reported as a score on a scale from 0 to 100 with a higher score being a better QOL.'}, {'measure': 'Lung Cancer Specific Quality of Life at 12 Months', 'timeFrame': '12 months post-discharge', 'description': 'Lung cancer specific Quality of Life will be measured by the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Lung Cancer-13 (EORTC QLQ-LC13) supplement and reported as a score from 0 to 100 with a higher score being worse symptoms'}, {'measure': 'PRO Symptom Monitoring Surveys Completed at 3 Months', 'timeFrame': '3 months post-discharge', 'description': 'The percentage of subjects who completed symptom surveys out of delivered symptom surveys.'}, {'measure': 'PRO Symptom Monitoring Alerts Resulting in a Clinician Response at 3 Months', 'timeFrame': '3 months post-discharge', 'description': 'The percentage of survey alerts that generate a clinician response will be calculated.'}, {'measure': 'Barriers and Facilitators of PRO Monitoring After Thoracic Surgery', 'timeFrame': 'assessed at 2 months through 2 years post-discharge', 'description': 'Barriers and facilitators of PRO monitoring after thoracic surgery will be assessed using qualitative methods. A subset of patients and caregivers participated in semi-structured interviews. Thematic analysis was used to identify determinants.'}], 'secondaryOutcomes': [{'measure': 'Readmission at 3 Months', 'timeFrame': '3 months post-discharge', 'description': 'Readmission rates after thoracic surgery.'}, {'measure': 'Overall Survival at 12 Months', 'timeFrame': '12 months post-discharge', 'description': 'Survival will be compared between arms using Cox proportional hazards regression model.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient-Reported Outcomes'], 'conditions': ['Thoracic Surgery']}, 'descriptionModule': {'briefSummary': 'This study is designed to test if patient-reported outcomes with automated reporting to clinicians for remote monitoring of postoperative symptoms is feasible and improves quality of life, health outcomes, and service utilization in thoracic surgery patients. Patients undergoing thoracic surgery will be asked to self-report symptoms for remote monitoring by their care team.', 'detailedDescription': "This is a single center, randomized feasibility study. A total of 140 patients undergoing thoracic surgery will be prospectively enrolled and randomized in a 1:1 ratio to one of two arms. All participants will complete patient-reported outcome (PRO) symptom monitoring. The two arms are 1) active symptom monitoring and 2) passive symptom monitoring. The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported. Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician. All participants will be administered survey instruments to assess quality of life, satisfaction, and health history. In addition, a subset of up to 40 participants will be chosen at 2 months postoperatively to complete a semi-structured interview about their postoperative symptom reporting experience."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* English speaking\n* Able and willing to complete web-based symptom survey\n* Be presenting for inpatient thoracic surgery\n\nExclusion Criteria:\n\n* Not completing planned surgery within 3 months of obtaining informed consent\n* Diagnosis of esophageal cancer\n* Inability to read and speak English\n* Presenting for a day surgery\n* Presenting for foregut surgery (e.g. paraesophageal hernia repair)\n* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n* Current incarceration\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04342260', 'briefTitle': 'Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Improving Quality of Life After Thoracic Surgery Using Patient-Reported Outcomes', 'orgStudyIdInfo': {'id': 'LCCC1945'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Monitoring', 'description': 'Clinicians will receive symptom alerts if the survey suggests increased or worsening symptoms.', 'interventionNames': ['Other: Active Monitoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Passive Monitoring', 'description': 'Clinicians will not receive any symptom alerts.', 'interventionNames': ['Other: Passive Monitoring']}], 'interventions': [{'name': 'Active Monitoring', 'type': 'OTHER', 'description': "The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported.", 'armGroupLabels': ['Active Monitoring']}, {'name': 'Passive Monitoring', 'type': 'OTHER', 'description': 'Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.', 'armGroupLabels': ['Passive Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Gita Mody, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plans as of now to make IPD available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thoracic Surgery Foundation', 'class': 'UNKNOWN'}, {'name': 'American College of Surgeons', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}