Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-03 @ 5:18 AM
Study NCT ID:
NCT02700256
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2016-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Reporting of Symptoms After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-01', 'studyFirstSubmitDate': '2016-03-02', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients who respond to the survery', 'timeFrame': 'up to 5 days after surgery', 'description': 'A patient will be deemed a "responder" if they complete at least 5 of the 8 symptom items on at least 3 days postoperatively. The symptom assessment method will be deemed successful if 32 of the 50 patients respond.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['surgery', '15-315'], 'conditions': ['Patients Scheduled to Undergo Surgery on the Gynecology Service']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to find out if patients are willing to self-report symptoms in the first 5 days following discharge, or when they leave the hospital after "ambulatory surgery" ("ambulatory surgery" is when the patient has surgery and then goes home within 24 hours).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled to undergo surgery on the Gynecology service through the AXR program or are discharged within 24-hours of surgery with internet access or a phone number will be recruited from the Rockefeller Outpatient Pavilion in the GYN Surgery Clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients must be undergoing surgery for an indication tracked within the Gynecologic AXR program or have an expected postoperative discharge within 24 hours of surgery. These surgical procedures typically include: minimally invasive hysterectomy or radical hysterectomy, salpingo-oophorectomies \\[mentioned above\\], and minimally invasive staging procedures.\n* The patient must have a phone number or an email address.\n* The patient must be willing to self-report postoperative symptoms over an automated phone system or via an online platform.\n* The patient must speak and read fluent English.\n\nExclusion Criteria:\n\n* Non-English speaking patients\n* Patients unwilling to provide contact information (email or phone number)'}, 'identificationModule': {'nctId': 'NCT02700256', 'briefTitle': 'Electronic Reporting of Symptoms After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Electronic Patient-Reported Outcomes in Patients Recovering From Ambulatory Cancer Surgery: Measuring Early Postoperative Symptoms', 'orgStudyIdInfo': {'id': '15-315'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing a procedure', 'description': "Patients will be asked to complete a baseline survey after enrollment. After surgery, enrollees who opt for the email/online access will receive an email upon discharge with a link to the WebCore site. Email will be sent at 9 am on postoperative day (POD) 2 to the email address the patient provided at consent. On post-operative days 2 through 6 the patient will be asked to complete a symptom inventory, they will receive an email with a link to the WebCore website, where they will be able to complete that day's survey. Enrollees who opt for the automated phone calls will complete their surveys via Interactive Voice Response (IVR), which will be automatically set-up to call the patient at 9 am on POD 2. Patients will complete phone surveys daily for 5 days. If the first phone call does not connect to the patient, a second phone call will be made at 10:00am. If the second call is unsuccessful a third \\& final call for that day will be placed at 11:00am.", 'interventionNames': ['Behavioral: survey']}], 'interventions': [{'name': 'survey', 'type': 'BEHAVIORAL', 'description': 'All patients will submit a baseline survey following enrollment onto study. After successful completion of the AXR or 24-hour discharge pathway, the consented patient will be contacted by email or telephone for 5 days following discharge from surgery.', 'armGroupLabels': ['Patients undergoing a procedure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memoral Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Monmouth', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Westchester', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11570', 'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Rockville Centre', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'overallOfficials': [{'name': 'Oliver Zivanovic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}