Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT01039493
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2009-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2009-12-23', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Utilities of complications associated with cervical cancer treatment.', 'timeFrame': 'At time of interview'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to establish patient preferences in regards to common complications of cervical cancer treatments, and to compare these preferences to those of medical providers who care for cervical cancer patients. These preferences will be determined via a interview using the Standard Gamble, which is a well-recognized method for establishing utilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '61 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patient Population: Patients ≥18 and \\<61 years old who were diagnosed with early cervical cancer (stages I and II) at least 3 years prior to the interview. We cannot limit our population to stage IB2 patients and meet our accrual goals due to the rarity of the disease. Patients with stages I and II cervical cancer are included because they have the potential to be exposed to the same treatment complications as patients with stage IB2 disease. Patients of all health statuses will be accepted.\n\nProvider Population: Providers who care for patients with cervical cancer at the University of Wisconsin, including: gynecologic oncologists, radiation oncologists, physician's assistants and nurses. Providers must be ≥18 and \\<61 years old in any health status.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A subject has to have been diagnosed with early cervical cancer (Stage I or II) within the last 3 years and/or take care of patients with cervical cancer and identify her or himself as one of the following: gynecologic oncologist, radiation oncologist, physician's assistant or nurse.\n* Subjects must be ≥18 and \\<61 years old.\n\nExclusion Criteria:\n\n* Subjects who are unable to read and speak English proficiently will be excluded. Proficiency will be assessed by the investigator enrolling patients.\n* Subjects who do not have capacity to consent will not be included in this study.\n* Subjects may not be investigators on this study."}, 'identificationModule': {'nctId': 'NCT01039493', 'briefTitle': 'Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications', 'orgStudyIdInfo': {'id': 'M-2009-1240'}, 'secondaryIdInfos': [{'id': 'OS09708', 'type': 'OTHER', 'domain': 'UW Carbone Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients'}, {'label': 'Providers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Ellen M Hartenbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}