Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT00772018
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2008-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life and Symptom Management in Patients With Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2008-10-12', 'studyFirstSubmitQcDate': '2008-10-12', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality of life (HRQOL) and symptom management in patients with bladder cancer', 'timeFrame': 'One timepoint', 'description': 'Study is a retrospective qualitative study of nonmuscle-invasive bladder cancer patients using a semi-structured interview protocol.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage 0 bladder cancer'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Learning about quality of life and symptom management in patients with bladder cancer may help doctors learn about the effects of treatment and plan the best treatment.\n\nPURPOSE: This clinical trial is studying of quality of life and symptom management in patients with bladder cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To identify aspects of health-related quality of life (HRQOL) and symptom management in patients with non-invasive, low- or high-risk bladder cancer.\n* To obtain feedback on data collection methods to enhance acceptability in these patients.\n\nOUTLINE: Patients undergo a 10-minute screening in person or by phone to obtain demographic data and medical information (e.g., bladder cancer diagnosis and treatment history). Additional information is obtained from the clinical databases at the Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center. Patients who are eligible for the study are added to a waiting list for 1 of 4 focus groups based on disease status (high-risk or low-risk non-invasive bladder cancer) and gender. Patients participate in a 1.5- to 2-hour focus group discussion about the impact of bladder cancer on their quality of life and relationships. Patients receive information about community and Internet-based resources at the end of each group session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Urology specialty clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of bladder cancer within the past 4 years\n\n * Non-invasive disease\n * Low- or high-risk disease\n* Recruited from patients at the Baylor College of Medicine Scott Department of Urology clinics, the Michael E. DeBakey Veteran Affairs Medical Center, and the Urology Clinic at MD Anderson Cancer Center OR from participants at a community event\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant\n* Able to read, speak, and understand English\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00772018', 'briefTitle': 'Quality of Life and Symptom Management in Patients With Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'A Qualitative Study of Patients With Non-Invasive Bladder Cancer', 'orgStudyIdInfo': {'id': 'CDR0000600591'}, 'secondaryIdInfos': [{'id': 'BCM-H-21570'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Dan L. Duncan Cancer Center at Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David M. Latini, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Latini', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'David Latini', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}