Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer

NCT06337305 | Completed

• 1 other identifier: STUDY00146138
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (3)

• Change in resiliency as measured by the Connor-Davidson Resilience Scale (CD-RISC-25).

  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.

  Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative

• Change in quality of life in patients undergoing radical cystectomy as measured by the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-Bl-Cys).

  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.

  Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative

• Change in quality of life in patients undergoing radical cystectomy as measured by the PROMIS-29.

  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.

  Prior to radical cystectomy, 10-30-days post-operative, and 90-days (+/-30-days) post-operative

Secondary Outcomes (2)

• Identification of clinical and demographic factors in bladder cancer patients

  Baseline to 90-days (+/-30 days) post-operative

• Demographics

  Baseline to 90-days (+/-30 days) post-operative

Study Arms (1)

Bladder cancer patients undergoing radical cystectomy.

This is a prospective cross-sectional survey of bladder cancer patients undergoing radical cystectomy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing radical cystectomy for bladder cancer

You may qualify if:

• 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

You may not qualify if:

• Patients opting to not undergo radical cystectomy
• Minors

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Urologic Oncology Fellowship Director

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 29, 2024
• Study Start: August 19, 2020
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)