Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT06337305
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2024-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resiliency in Patients Undergoing Radical Cystectomy for 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in resiliency as measured by the Connor-Davidson Resilience Scale (CD-RISC-25).', 'timeFrame': 'Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative', 'description': 'The Connor-Davidson Resilience scale is a 25-item self-administered instrument for assessing resilience that is consistent in a variety of populations, including clinical and community.\n\nScoring: 0-100 (sum total of all items, each of which is scored 0-4). Higher score reflects greater resilience.'}, {'measure': 'Change in quality of life in patients undergoing radical cystectomy as measured by the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-Bl-Cys).', 'timeFrame': 'Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative', 'description': 'The FACT-BL-Cys is a condition-specific instrument for patients undergoing radical cystectomy to measure quality of life.\n\nScoring: 0-168 (sum total of all items). Higher score reflects better health-related quality of life.'}, {'measure': 'Change in quality of life in patients undergoing radical cystectomy as measured by the PROMIS-29.', 'timeFrame': 'Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative', 'description': 'The PROMIS-29 is a disease non-specific measure of pain intensity using a 1-5 rating and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance).\n\nScoring: High scores mean more of the concept being measured.'}], 'secondaryOutcomes': [{'measure': 'Identification of clinical and demographic factors in bladder cancer patients', 'timeFrame': 'Baseline to 90-days (+/-30 days) post-operative', 'description': 'Identify clinical and demographic factors related to higher post-cystectomy resiliency in patients with bladder cancer.'}, {'measure': 'Demographics', 'timeFrame': 'Baseline to 90-days (+/-30 days) post-operative', 'description': 'Characterize trends that correspond with greater levels of resiliency and quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective cross-sectional survey-based study composed of both a retrospective chart review and 3-series patient survey. This study will help elicit potential areas throughout the perioperative course of radical cystectomy to improve patient resilience and quality of life, providing opportunity for future interventional studies.', 'detailedDescription': "This is a prospective cross-sectional survey-based study composed of both a retrospective chart review and 3-series patient survey. This study will help elicit potential areas throughout the perioperative course of radical cystectomy to improve patient resilience and quality of life, providing opportunity for future interventional studies. Primarily, the study will evaluate health related quality of life and resiliency in patients throughout the perioperative course of a radical cystectomy for bladder cancer.\n\nThe primary objective will be the correlation of the Connor-Davidson Resilience Scale (CD-RISC-25) and the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-BL-Cys) score.\n\nPatients will be identified and undergo consent and baseline assessments, including completion of surveys prior to their cystectomy. A retrospective chart review will also be completed to record information regarding patient's cancer stage, treatment status, diagnosis date, insurance type, and related medical conditions and medications. Data from retrospective chart review will be collected and recorded in a secure REDCap database for all eligible patients.\n\nSubsequent surveys will be administered again at approximately 10-30 days postoperatively, as well as 60-120 days postoperatively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing radical cystectomy for bladder cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of bladder cancer\n* Patients electing to undergo radical cystectomy as treatment\n* ≥ 18 years of age\n* Able to speak and read English\n* Willing and able to provide informed consent\n* Functioning telephone number or access to one\n\nExclusion Criteria:\n\n* Patients opting to not undergo radical cystectomy\n* Minors'}, 'identificationModule': {'nctId': 'NCT06337305', 'briefTitle': 'Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer', 'orgStudyIdInfo': {'id': 'STUDY00146138'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bladder cancer patients undergoing radical cystectomy.', 'description': 'This is a prospective cross-sectional survey of bladder cancer patients undergoing radical cystectomy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor and Urologic Oncology Fellowship Director', 'investigatorFullName': 'Eugene Lee, MD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}