Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer

Completed

• Conditions: Bladder Cancer

• Registration Number: NCT06337305
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

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.

The 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.

Patients 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.

Subsequent surveys will be administered again at approximately 10-30 days postoperatively, as well as 60-120 days postoperatively.

Study Timeline

• Study Start: 2020-08-19
• Primary Completion: 2022-08-19
• Study Completion: 2023-08-19
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-03-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Patients with a diagnosis of bladder cancer
• Patients electing to undergo radical cystectomy as treatment
• ≥ 18 years of age
• Able to speak and read English
• Willing and able to provide informed consent
• Functioning telephone number or access to one

Exclusion Criteria

• Patients opting to not undergo radical cystectomy
• Minors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in quality of life in patients undergoing radical cystectomy as measured by the PROMIS-29.	Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative	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).; Scoring: High scores mean more of the concept being measured.
Change in resiliency as measured by the Connor-Davidson Resilience Scale (CD-RISC-25).	Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative	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.; Scoring: 0-100 (sum total of all items, each of which is scored 0-4). Higher score reflects greater resilience.
Change in quality of life in patients undergoing radical cystectomy as measured by the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-Bl-Cys).	Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative	The FACT-BL-Cys is a condition-specific instrument for patients undergoing radical cystectomy to measure quality of life.; Scoring: 0-168 (sum total of all items). Higher score reflects better health-related quality of life.

Secondary Outcome Measures

Name	Time	Method
Demographics	Baseline to 90-days (+/-30 days) post-operative	Characterize trends that correspond with greater levels of resiliency and quality of life
Identification of clinical and demographic factors in bladder cancer patients	Baseline to 90-days (+/-30 days) post-operative	Identify clinical and demographic factors related to higher post-cystectomy resiliency in patients with bladder cancer.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States