Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chid@mskcc.org', 'phone': '212-639-5016', 'title': 'Dr. Dennis Chi ME', 'organization': 'Memorial Sloan Kettering Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 16 weeks (between 6-8 weeks post surgery)', 'eventGroups': [{'id': 'EG000', 'title': 'GYN Pts Undergoing Surgery', 'description': 'This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).\n\nonline platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 85, 'seriousNumAtRisk': 120, 'deathsNumAffected': 27, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'ECOG Performance Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GYN Pts Undergoing Surgery', 'description': 'This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).\n\nonline platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.'}], 'classes': [{'categories': [{'title': 'Requested to be removed from study', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Did not undergo lapartomy', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Incompatible internet browser', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Died', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Completed preoperative session in STAR', 'measurements': [{'value': '69', 'groupId': 'OG000'}]}, {'title': "Didn't complete preop, completed other surveys", 'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Feasibility of Online Symptom Self-reporting in the Early Postoperative Period, and Clinician Perceptions of Its Potential Value in Routine Outpatient Post-operative Cancer Care.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Nurse Clinicians', 'description': "Email alerts were sent to study nurses when concerning participant responses were entered. The nurse assessments of STAR's usefulness were measured via an exit survey. Alerts were considered concerning according to pre-specified limits set by the Gynecologic Oncology Service. This is the same system presently used to triage patient phone calls. Any actions taken by the nurses in response to these alerts were recorded. However, specific responses were not required. Patients were encouraged to call their physician's office if medical attention was needed, as there was no regularly scheduled monitoring of information entered into the STAR system."}], 'classes': [{'categories': [{'title': 'Left MSK before close of study', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Did not complete Clinician Exit Survey', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Reported increased workload bc of STAR system', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Nurses who participated in the study'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Impact of Online Symptom Self-reporting on Patient Care Processes as Measured by the Number of Telephone Calls Between Nurses and Patients,Resulting Interventions and Patient Satisfaction With Care Delivery.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GYN Pts Undergoing Surgery', 'description': 'This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).\n\nonline platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.'}], 'timeFrame': 'two years', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GYN Pts Undergoing Surgery', 'description': 'This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).\n\nonline platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.'}], 'classes': [{'title': 'ECOG Performance Status', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Trouble with Strenuos Activities', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weekly starting 7 days after surgery until the 6-week post-operative period', 'description': 'The percentage of symptoms generated by patients on protocol', 'unitOfMeasure': 'percentage of symptoms', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GYN Pts Undergoing Surgery', 'description': 'This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).\n\nonline platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Did not undergo laparotomy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Incompatible internet browser', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GYN Pts Undergoing Surgery', 'description': 'This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).\n\nonline platform WEBCORE: Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '120', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '113', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-02-28', 'size': 1039120, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-16T08:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2009-03-26', 'resultsFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-19', 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery', 'timeFrame': 'once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.'}], 'secondaryOutcomes': [{'measure': 'Feasibility of Online Symptom Self-reporting in the Early Postoperative Period, and Clinician Perceptions of Its Potential Value in Routine Outpatient Post-operative Cancer Care.', 'timeFrame': 'once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended'}, {'measure': 'To Evaluate the Impact of Online Symptom Self-reporting on Patient Care Processes as Measured by the Number of Telephone Calls Between Nurses and Patients,Resulting Interventions and Patient Satisfaction With Care Delivery.', 'timeFrame': 'two years'}, {'measure': 'Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System', 'timeFrame': 'weekly starting 7 days after surgery until the 6-week post-operative period', 'description': 'The percentage of symptoms generated by patients on protocol'}]}, 'conditionsModule': {'keywords': ['Gynecologic cancers', 'Quality of Life', '08-155', 'Surgery'], 'conditions': ['Fallopian Tube Cancer', 'Ovarian Cancer', 'Peritoneal Cancer', 'Uterine Cancer', 'Vaginal Cancer', 'Vulvar Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': "This study is being done to see if most patients are willing and able to report how they are feeling after surgery using the internet, and if this information can help doctors and nurses detect concerning symptoms after surgery.\n\nThis study uses a special new website called WEBCORE. Patients can logon to WEBCORE and answer questions about how they are feeling. Then, doctors and nurses can look at this information during clinic appointments. We are doing this study to see if WEBCORE is a helpful way for us to keep track of information about how patients are feeling and quality of life. If WEBCORE is helpful, we will use it in the future to collect more information about patients' symptoms and quality of life. We can use what we learn to help find better ways of helping patients to prepare for what they will go through while they recover from surgery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing laparotomy for presumed or confirmed gynecologic malignancy at MSKCC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be 18 years or older\n* Participants must be able to provide informed consent\n* Participants must be scheduled to undergo laparotomy for presumed or known gynecologic cancer\n* The assessments were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the tests. Participants must be able to speak and read English fluently\n* Participants must have access to a home computer, have a personal email account, and check email at least once weekly by self-report\n\nExclusion Criteria:\n\n* Patients who have a cognitive or psychiatric deficit resulting in an inability to provide meaningful informed consent, as judged by the consenting professional, and/or as noted in the medical record\n* Patients who are undergoing pelvic exenterative surgery (with the exception of patients undergoing modified pelvic exenteration in the context of debulking for ovarian or uterine cancer).'}, 'identificationModule': {'nctId': 'NCT00870233', 'briefTitle': 'Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Electronic Patient-Reported Outcomes From Home in Patients Recovering From Major Gynecologic Cancer Surgery: Measuring Symptoms and Health-related Quality of Life', 'orgStudyIdInfo': {'id': '08-155'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GYN pts undergoing surgery', 'description': 'This study will assess patient use of WEBCORE, an online system designed for cancer patients to self-record toxicity-related symptoms based on NCI Common Terminology Criteria for Adverse Events and global quality of life (QoL) by European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).', 'interventionNames': ['Behavioral: online platform WEBCORE']}], 'interventions': [{'name': 'online platform WEBCORE', 'type': 'BEHAVIORAL', 'otherNames': ['If an enrolled patient fails to login and self-report within 24 hours of', 'the automated reminder, a second reminder email will be sent. If the', 'patient again fails to respond, a backup telephone call to the patient', 'will be made by the clinical research fellow coordinating this study.', 'The back-up phone call will be made within a week of the initial missed', 'questionnaire. If the patient is unreachable, a total of 3 attempts will', 'be made to reach the patient.'], 'description': 'Enrollees will be sent weekly email reminders to login to WEBCORE from home. Participants will be expected to complete the questionnaire once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.', 'armGroupLabels': ['GYN pts undergoing surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Dennis Chi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}