Clinical trial NCT06337305: Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer
Official title: Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing radical cystectomy for bladder cancer

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.

Eligibility criteria: 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

Primary outcomes:
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
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
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
Secondary outcomes:
measure: Identification of clinical and demographic factors in bladder cancer patients
timeFrame: Baseline to 90-days (+/-30 days) post-operative
measure: Demographics
timeFrame: Baseline to 90-days (+/-30 days) post-operative
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References: