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Completed

NCT Number: NCT06337305

Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Identification of clinical and demographic factors in bladder cancer patients

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

    Identify clinical and demographic factors related to higher post-cystectomy resiliency in patients with bladder cancer.

  2. Demographics

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

    Characterize trends that correspond with greater levels of resiliency and quality of life

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 29, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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