Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00203918
Status:
COMPLETED
Last Update Posted:
2017-08-30
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prostate Cancer Utilities and Cost-Effectiveness Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], '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': 481}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Utility scores for treatment outcomes', 'timeFrame': '90 days after enrollment', 'description': 'Patient utility scores (i.e. patient preference weights) are calculated using survery data will determine which prostate cancer treatment would be most cost-effective for each subject. Patients will be contacted by phone and patient records will be reviewed 90 days after the survey has been completed to determine whether this data reflects actual treatment decisions.'}], 'secondaryOutcomes': [{'measure': 'Anxiety levels', 'timeFrame': '90 days after enrollment', 'description': 'We will also ask patients questions relating to their anxiety levels concerning the possible diagnosis of prostate cancer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Cost-Effectiveness Analysis', 'Utility Assessment'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to help doctors and patients make better decisions about prostate cancer treatment. This research is being done because we do not know how patient preferences for health states related to prostate cancer affect the final treatment decision.', 'detailedDescription': "The goal of this project is to incorporate patients' preferences into a previously developed prostate cancer treatment decision-model and to understand the implications for doing so for cost-effectiveness analysis. To do this, it is first necessary to obtain patient utility scores (i.e., patient preference weights). To do this we will perform a survey of patients visiting the urology clinic to undergo prostate biopsies to validate a method of utility assessment, and understand the patients' individual evaluations of treatment-related health studies. We will also ask patients questions relating to their anxiety levels concerning the possible diagnosis of prostate cancer."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients visiting the urology clinic at the University of Chicago.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing prostate biopsy\n\nExclusion Criteria:\n\n* Women and children will be excluded, as prostate cancer occurs in men only\n* Diagnosis of dementia'}, 'identificationModule': {'nctId': 'NCT00203918', 'briefTitle': 'Prostate Cancer Utilities and Cost-Effectiveness Analysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Prostate Cancer Utilities and Cost-Effectiveness Analysis', 'orgStudyIdInfo': {'id': '12843B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prostate biopsies', 'description': 'Males undergoing prostate biopsies', 'interventionNames': ['Behavioral: Survey, interview', 'Behavioral: patient utility scores (i.e. patient preference weights)']}], 'interventions': [{'name': 'Survey, interview', 'type': 'BEHAVIORAL', 'description': "A survey is administered to patients visiting the urology clinic to undergo prostate biopsies to validate a method of utility assessment, and understand patients' individual evaluations of treatment-related health states. Medical records will also be reviewed 00 days after the survey was administered to determine whether this data reflects actual treatment decisions.", 'armGroupLabels': ['Prostate biopsies']}, {'name': 'patient utility scores (i.e. patient preference weights)', 'type': 'BEHAVIORAL', 'description': 'comparison of patient preferences', 'armGroupLabels': ['Prostate biopsies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'David Meltzer, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}