Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT02036268
Status:
TERMINATED
Last Update Posted:
2024-05-22
First Post:
2014-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Levels of Patient Education for Care of Ostomy Site
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'whyStopped': 'Lack of study coordinator and time.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stoma Quality of Life Scale (SQOLS)', 'timeFrame': 'Six weeks', 'description': 'The SQOLS assesses patient quality of life on a 5-point Likert type scale, where 1 = Never and 5 = Always. Higher scores indicate a greater self-reported quality of life.'}], 'secondaryOutcomes': [{'measure': 'Skin integrity at the ostomy site by lesion type', 'timeFrame': 'Six weeks', 'description': 'Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion type.'}, {'measure': 'Skin integrity at the ostomy site by location', 'timeFrame': 'Six weeks', 'description': 'Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion location.'}, {'measure': 'Number of appliance changes', 'timeFrame': 'Six weeks', 'description': 'Subjects will be asked to record the number of wafer and/or bag changes completed during study participation in a patient diary.'}, {'measure': 'Stoma Care Self-Efficacy Scale (SCSES)', 'timeFrame': 'Six weeks', 'description': 'The SCSES assesses patient quality of life on a 4-point Likert type scale, where 1 = Not At All and 5 = Almost Always. Higher scores indicate a greater self-reported quality of life related to self-confidence in stoma care.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ostomy education', 'Education', 'care of ostomy site'], 'conditions': ['Ostomy']}, 'descriptionModule': {'briefSummary': 'This is a randomized study of standard versus extra ostomy education.', 'detailedDescription': 'The purpose of this study is to evaluate the effectiveness of pre-operative and post-operative ostomy education compared to standard of care ostomy education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age equal to or greater than 18 years of age at the time of consent.\n* Scheduled to undergo surgery at IU Health North Hospital that will results in a temporary or permanent colostomy or ileostomy for a benign or malignant disease process.\n* Are willing and able to provide written informed consent for participation in the study and authorization for release of health information.\n* Are willing and able to attend up to two additional clinic visits at IU Health North Hospital for the purpose of ostomy teaching and care.\n* Subjects who currently do NOT have a urostomy or any other type of urinary diversion and/or are NOT planning to have a urostomy or any other type of urinary diversion as part of the surgery procedures at the time of their surgery for placement of colostomy or ileostomy.\n* Subjects who do NOT have any history of prior colostomy or ileostomy.\n\nExclusion Criteria:\n\n* Subjects not meeting any of the above eligibility criteria.'}, 'identificationModule': {'nctId': 'NCT02036268', 'briefTitle': 'Different Levels of Patient Education for Care of Ostomy Site', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'A Prospective, Single-Center Study to Assess the Impact of Pre- and Post-Surgical Ostomy Care Education on Patient Outcomes and Quality of Life', 'orgStudyIdInfo': {'id': '1202007926'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'description': 'Subjects will receive standard ostomy education.', 'interventionNames': ['Behavioral: Standard']}, {'type': 'EXPERIMENTAL', 'label': 'Pre-Operative Education', 'description': 'In addition to standard ostomy education, subjects will receive additional education pre-operatively.', 'interventionNames': ['Behavioral: Standard', 'Behavioral: Pre-operative Education']}, {'type': 'EXPERIMENTAL', 'label': 'Two-week Post Operative Education', 'description': 'In addition to standard ostomy education, subjects will receive additional education two weeks following surgery.', 'interventionNames': ['Behavioral: Standard', 'Behavioral: Pre-operative Education', 'Behavioral: Two-week Post Operative Education']}], 'interventions': [{'name': 'Standard', 'type': 'BEHAVIORAL', 'description': 'Standard ostomy education', 'armGroupLabels': ['Pre-Operative Education', 'Standard', 'Two-week Post Operative Education']}, {'name': 'Pre-operative Education', 'type': 'BEHAVIORAL', 'description': 'In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.', 'armGroupLabels': ['Pre-Operative Education', 'Two-week Post Operative Education']}, {'name': 'Two-week Post Operative Education', 'type': 'BEHAVIORAL', 'description': 'In addition to standard ostomy education and an additional pre-operative ostomy education session, another ostomy education session will be conducted with the subject two weeks post-op.', 'armGroupLabels': ['Two-week Post Operative Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health North Hospital', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}], 'overallOfficials': [{'name': 'Bruce W Robb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University, Department of Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor of Surgery', 'investigatorFullName': 'Bruce W. Robb', 'investigatorAffiliation': 'Indiana University'}}}}