Bladder CancerNCT06337305
Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer
An observational study of Bladder Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2020to 19 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing radical cystectomy for bladder cancer
Who may be able to join
- 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
Who cannot join
- Patients opting to not undergo radical cystectomy
- Minors
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
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.
Read the 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.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bladder cancer patients undergoing radical cystectomy. | This is a prospective cross-sectional survey of bladder cancer patients undergoing radical cystectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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
Identify clinical and demographic factors related to higher post-cystectomy resiliency in patients with bladder cancer.
Measured: Baseline to 90-days (+/-30 days) post-operative
Demographics
Characterize trends that correspond with greater levels of resiliency and quality of life
Measured: Baseline to 90-days (+/-30 days) post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start19 Aug 2020
- Primary completion19 Aug 2022
- Study completion19 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugene Lee, MD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337305
- Sponsor's protocol ID
- STUDY00146138
- Status last verified
- Oct 2024
- First submitted
- 8 Mar 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer
- ClinicalTrials.gov ID
- NCT06337305
- Acronym / sponsor ID
- STUDY00146138
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 19 Aug 2023 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder cancer patients undergoing radical cystectomy. | – | –This is a prospective cross-sectional survey of bladder cancer patients undergoing radical cystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing radical cystectomy for bladder cancer
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients opting to not undergo radical cystectomy
- Minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
2 secondary outcomes
Identification of clinical and demographic factors in bladder cancer patients
Time frame: Baseline to 90-days (+/-30 days) post-operative
Demographics
Time frame: Baseline to 90-days (+/-30 days) post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.