Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-03-09 @ 9:56 AM
Study NCT ID:
NCT01721304
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2012-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decisionmaking for Abnormal Uterine Bleeding (AUB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine 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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2012-10-25', 'studyFirstSubmitQcDate': '2012-11-01', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in patient-reported satisfaction between treatment groups', 'timeFrame': '6 weeks', 'description': 'Satisfaction with care as measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Scale (FACT-TS-PS)'}, {'measure': 'Differences in decision regret between treatment groups', 'timeFrame': '6 weeks', 'description': 'Decision regret is measured by the Decision Regret Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['decision making', 'abnormal uterine bleeding', 'adaptive conjoint analysis', 'satisfaction', 'regret'], 'conditions': ['Abnormal Uterine Bleeding']}, 'referencesModule': {'references': [{'pmid': '25074354', 'type': 'RESULT', 'citation': 'Hess LM, Litwiller A, Byron J, Stutsman J, Kasper K, Learman LA. Preference elicitation tool for abnormal uterine bleeding treatment: a randomized controlled trial. Patient. 2015 Apr;8(2):217-27. doi: 10.1007/s40271-014-0078-8.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25074354', 'label': 'Preference elicitation tool for abnormal uterine bleeding treatment: a randomized controlled trial.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study is a two-part study. The first pilot tests the computerized tool to ensure it is understood by patients, then the second part is a randomized study (computerized tool versus usual care) to see if improvements are made in satisfaction and if there are reductions in decision regret.', 'detailedDescription': 'The purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (AUB) is useful and if it will improve patient satisfaction with clinical care and decision making. This study was designed to develop and test the use of ACA as part of routine clinical care for women diagnosed with AUB. After pilot testing, the ACA survey is administered in this study where patients are assigned to receive the ACA or to usual care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have received a diagnosis of dysfunctional or abnormal uterine bleeding (AUB) that is recommended for treatment\n* Have not yet selected or initiated treatment for current AUB diagnosis\n* Be at least 18 years of age.\n* Be possible candidates for either medical or surgical therapy\n* Able to provide informed consent for treatment options for oneself\n\nExclusion Criteria:\n\n* Are currently being treated for cancer\n* Any cancer diagnosis within the past 2 years (other than non-melanoma skin cancer)\n* AUB due to serious pelvic pathology, medications, pregnancy or systemic disease that limits their range of treatment options\n* Are not recommended for surgical intervention\n* Are not recommended for medical intervention\n* Are under 18 years of age\n* Have not received a diagnosis of AUB\n* Are currently being treated for AUB'}, 'identificationModule': {'nctId': 'NCT01721304', 'briefTitle': 'Decisionmaking for Abnormal Uterine Bleeding (AUB)', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Decision Making Among Treatment Alternatives for Abnormal Uterine Bleeding (AUB)', 'orgStudyIdInfo': {'id': '1009001853 (0904-66B)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adaptive Conjoint Analysis', 'description': 'Computerized survey to elicit preferences', 'interventionNames': ['Other: Adaptive Conjoint Analysis']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Patients are counseled by their physician as usual'}], 'interventions': [{'name': 'Adaptive Conjoint Analysis', 'type': 'OTHER', 'description': 'Computerized survey to elicit patient preferences', 'armGroupLabels': ['Adaptive Conjoint Analysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '28388', 'city': 'Southern Pines', 'state': 'North Carolina', 'country': 'United States', 'facility': "Southern Pines Women's Health Center", 'geoPoint': {'lat': 35.17405, 'lon': -79.39225}}], 'overallOfficials': [{'name': 'Lisa M Hess, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine and Public Health', 'investigatorFullName': 'Lisa Hess', 'investigatorAffiliation': 'Indiana University'}}}}