Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT06350734
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2024-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 704}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in quality of life outcomes - PROMIS-29', 'timeFrame': 'At baseline, 6, 12, 24, and 36 months', 'description': 'Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29, a 29-item instrument with 29 questions in eight categories of Health Related Quality of Life (HRQOL): physical function, sleep disturbance, pain interference and pain intensity, fatigue, anxiety, depression) and ability to participate in social roles and activities. Questions are answered on a 5-point scale with varying responses assigned to the scale based on the category/question.'}, {'measure': 'Change in quality of life outcomes - Bladder Cancer Index', 'timeFrame': 'At baseline, 6, 12, 24, and 36 months', 'description': 'Assessed using the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales for each item, covering 3 primary domains: urinary (14 items), bowel (10 items), and sexual (12 items). The items focus on the frequency of the disease symptoms, with answer scales such as: "Never, rarely, about half the time, usually, or always".'}, {'measure': 'Patient level characteristics', 'timeFrame': 'At baseline, 6, 12, 24, and 36 months after treatment', 'description': 'Will be assessed by the effect of race/ethnicity, comorbid conditions, education level, gender, and age on patient reported outcomes. Interactions between intervention type and patient-level characteristics will be included. The distributions of variables will be summarized graphically and numerically.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage 0a Bladder Cancer AJCC v8', 'Stage 0is Bladder Cancer AJCC v8', 'Stage I Bladder Cancer AJCC v8', 'Stage II Bladder Cancer AJCC v8', 'Stage IIIA Bladder Cancer AJCC v8']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of bladder cancer treatment on quality of life.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To compare general and disease-specific quality of life outcomes at 6, 12, 24, and 36 months after treatment for localized bladder cancer using the PROMIS-29 and the Bladder Cancer Index (BCI) respectively.\n\nII. To identify patient level characteristics that may influence quality of life outcomes after treatment for localized bladder cancer.\n\nOUTLINE: This is an observational study.\n\nPatients complete surveys and also have their medical records reviewed on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women diagnosed with clinically localized bladder cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have pathologically confirmed, clinically localized, bladder cancer\n* Be willing to complete a survey in English before starting definitive treatment (surgery or radiation);\n* Able to give consent.\n\nExclusion Criteria:\n\n* Does not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06350734', 'briefTitle': 'Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study', 'orgStudyIdInfo': {'id': '18-004675'}, 'secondaryIdInfos': [{'id': 'NCI-2024-00973', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '18-004675', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients complete surveys and also have their medical records reviewed on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-Interventional Study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Mark D. Tyson, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224-9980', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Paul R. Young, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Matthew T. Gettman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Mark D. Tyson, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}