Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Bladder cancer patients undergoing radical cystectomy.
This is a prospective cross-sectional survey of bladder cancer patients undergoing radical cystectomy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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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
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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
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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
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Identification of clinical and demographic factors in bladder cancer patients
Time Frame: Baseline to 90-days (+/-30 days) post-operative
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Identify clinical and demographic factors related to higher post-cystectomy resiliency in patients with bladder cancer.
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Baseline to 90-days (+/-30 days) post-operative
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Demographics
Time Frame: Baseline to 90-days (+/-30 days) post-operative
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Characterize trends that correspond with greater levels of resiliency and quality of life
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Baseline to 90-days (+/-30 days) post-operative
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00146138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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