Bladder CancerCOARCNCT05714826
Comprehensive Optimization At-time of Radical Cystectomy Intervention
A study testing Preop Intervention and Monitored Recovery in people with Bladder Cancer and Radical Cystectomy, run by University of Texas Southwestern Medical Center.
Trial summary
The proposed study is aimed at a comprehensive optimization at-time of radical cystectomy (COARC) intervention that focuses on patient optimization throughout the perioperative continuum, from the pre-operative setting to the post-operative period, among patients undergoing radical cystectomy for bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Radical Cystectomy
- What is being tested?
- Preop Intervention and Monitored Recovery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2026to 24 Aug 2026
- Phase
- Interventional
- 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
Who may be able to join
- Adults equal to or more than 18 years old
- Diagnosis of bladder cancer with plan to undergo radical cystectomy
- Agrees to participate in study procedures
Who cannot join
- Patients undergoing cystectomy for diagnosis other than bladder cancer
- Do not provide informed consent
About this study
Official title: Comprehensive Optimization At-time of Radical Cystectomy Intervention Through Peri-operative Patient Care Program
The proposed study is aimed at a comprehensive optimization at-time of radical cystectomy (COARC) intervention that focuses on patient optimization throughout the perioperative continuum, from the pre-operative setting to the post-operative period, among patients undergoing radical cystectomy for bladder cancer. This multi-modal strategy will focus on three phases of care around surgery: the pre-operative, peri-operative, and post-operative phases. The intervention group will focus on multiple areas of patient optimization including remote patient monitoring for the earlier identification of potential complications. The overall study mission is to decrease complication rates after radical cystectomy using this comprehensive approach.
Read the detailed description
The proposed study includes the following-
Part I: Pre-operative period After randomization, patients in the intervention group will be referred to the Perioperative Optimization of Senior Health (POSH) program where they will undergo nutritional, functional, and global health assessment. The POSH team will refer patients as indicated to nutrition, physical medicine and rehabilitation, and other consultants to optimize their preoperative fitness for surgery.
Patients in the intervention group will also receive a Remote Patient Monitoring (RPM) Ipad from ActiCare Health, which will serve as their remote monitoring device and educational tool. At enrollment, they will be asked to complete an initial steps intake using a pedometer that will be provided to them. They will be asked to input vital signs once per week after receiving the Ipad to become familiar with the platform pre-operatively.
At enrollment, patients in both groups will also be asked to complete a patient reported Bladder Cancer Index questionnaire, a survey that tracks quality of life in patients with bladder cancer.
Part II: Perioperative period Both the intervention and control groups will undergo standard of care Enhanced Recover After Surgery (ERAS) bladder cancer protocol, which is a medication and peri-operative management protocol developed by the anesthesia and urology departments specifically for bladder cancer patients undergoing radical cystectomy.
While admitted in the hospital recovering from surgery, patients in the intervention group will automatically receive co-management from the POSH team.
Part III: Post-operative period Both the intervention and the control groups will be followed for 90 days post-operatively. The intervention group will use the RPM Ipad to input vital signs, weight, and pedometer steps 3x/week and on an as needed basis over the follow-up period which will be monitored by the ActiCare Health 24/7 clinical support team. Abnormal parameters will be set so that the UT Southwestern Medical Center clinical care team is alerted to any abnormal values.
- Conditions
- Bladder Cancer, Radical Cystectomy
- Being tested
- Preop Intervention and Monitored Recovery, Usual Care
- Keywords
- Peri-operative
- 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.
Preop Intervention and Monitored RecoveryOther
Also called Monitored recovery during post-operative phase
Perioperative Optimization of Senior Health (POSH) Program; patient monitoring by device orientation, initial intake, education; ERAS protocol, inpatient geriatric co-management; and remote monitoring with Acticare device; post-op continuity of care
Usual CareOther
ERAS, Usual referral and recovery care, and Standard follow-up protocol
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Preop intervention Arm Referral to Perioperative Optimization of Senior Health (POSH) Program Remote patient monitoring device orientation, initial intake, and education UTSW ERAS protocol perioperatively Inpatient geriatrics co-management Monitored recovery Post-operative monitoring with Acticare for 90 days Post-op specialist continuity of care Receives: Other: Preop Intervention and Monitored Recovery |
| Control Arm | Active comparator | Enhanced Recovery After Surgery Usual referral and recovery care as needed Standard follow-up protocol Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 day complication rate
Number of occurrences of complications at 90 days in patients in post-operative phase
Measured: 90 days
Secondary outcomes (5)
30 day complication rate
Number of occurrences of complications at 30 days in patients in post-operative phase
Measured: 30 days
Readmission rates
Number of readmissions
Measured: 90 days
Adherence to the intervention
It is assessed via patient-self report measure
Measured: 90 days
Changes in functional fitness as measured by step count
Changes in functional fitness will be measured by step count
Measured: Baseline, 90 days
QOL changes as measured by the Bladder Cancer Index and FACT-Bl-Cys Questionnaire measures
Changes in patient reported outcomes will be measured by QOL (Bladder Cancer Index questionnaire). Possible scores range from 0-100, where higher scores indicate better HRQOL outcome.
Changes will also be measured using the FACT-Bl-Cys tool to assess changes in bladder related quality of life in patients undergoing cystectomy over the course of the study.
Measured: Baseline, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study startMay 2026 (estimated)
- Primary completion25 May 2026 (estimated)
- Study completion24 Aug 2026 (estimated)
Why it stopped: Recruitment efforts had begun; however, no participants were enrolled, and the trial had been on a prolonged hold.
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a prospective randomized study that implements a multi-modal digitally based comprehensive health optimization program in the pre and post-operative setting in patients undergoing radical cystectomy for muscle invasive bladder cancer. Two patient groups will be enrolled and randomized where one group will go through the peri-operative optimization programs and the other group will receive the usual pre-op care followed by post-op care via standard follow-up protocol.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yair lotan, University of Texas Southwestern Medical Center
- Investigators
- Yair Lotan, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714826
- Sponsor's protocol ID
- STU-2022-1221
- Acronym
- COARC
- Status last verified
- May 2026
- First submitted
- 26 Jan 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Optimization At-time of Radical Cystectomy Intervention Through Peri-operative Patient Care Program
- ClinicalTrials.gov ID
- NCT05714826
- Acronym / sponsor ID
- COARC / STU-2022-1221
- Conditions
- Bladder Cancer, Radical Cystectomy
- Keywords
- Peri-operative
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment efforts had begun; however, no participants were enrolled, and the trial had been on a prolonged hold.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 24 Aug 2026 (estimated)
- First posted
- 6 Feb 2023 (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.
The proposed study is aimed at a comprehensive optimization at-time of radical cystectomy (COARC) intervention that focuses on patient optimization throughout the perioperative continuum, from the pre-operative setting to the post-operative period, among patients undergoing radical cystectomy for bladder cancer. This multi-modal strategy will focus on three phases of care around surgery: the pre-operative, peri-operative, and post-operative phases. The intervention group will focus on multiple areas of patient optimization including remote patient monitoring for the earlier identification of potential complications. The overall study mission is to decrease complication rates after radical cystectomy using this comprehensive approach.
Detailed description
The proposed study includes the following-
Part I: Pre-operative period After randomization, patients in the intervention group will be referred to the Perioperative Optimization of Senior Health (POSH) program where they will undergo nutritional, functional, and global health assessment. The POSH team will refer patients as indicated to nutrition, physical medicine and rehabilitation, and other consultants to optimize their preoperative fitness for surgery.
Patients in the intervention group will also receive a Remote Patient Monitoring (RPM) Ipad from ActiCare Health, which will serve as their remote monitoring device and educational tool. At enrollment, they will be asked to complete an initial steps intake using a pedometer that will be provided to them. They will be asked to input vital signs once per week after receiving the Ipad to become familiar with the platform pre-operatively.
At enrollment, patients in both groups will also be asked to complete a patient reported Bladder Cancer Index questionnaire, a survey that tracks quality of life in patients with bladder cancer.
Part II: Perioperative period Both the intervention and control groups will undergo standard of care Enhanced Recover After Surgery (ERAS) bladder cancer protocol, which is a medication and peri-operative management protocol developed by the anesthesia and urology departments specifically for bladder cancer patients undergoing radical cystectomy.
While admitted in the hospital recovering from surgery, patients in the intervention group will automatically receive co-management from the POSH team.
Part III: Post-operative period Both the intervention and the control groups will be followed for 90 days post-operatively. The intervention group will use the RPM Ipad to input vital signs, weight, and pedometer steps 3x/week and on an as needed basis over the follow-up period which will be monitored by the ActiCare Health 24/7 clinical support team. Abnormal parameters will be set so that the UT Southwestern Medical Center clinical care team is alerted to any abnormal values.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a prospective randomized study that implements a multi-modal digitally based comprehensive health optimization program in the pre and post-operative setting in patients undergoing radical cystectomy for muscle invasive bladder cancer. Two patient groups will be enrolled and randomized where one group will go through the peri-operative optimization programs and the other group will receive the usual pre-op care followed by post-op care via standard follow-up protocol.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Preop Intervention and Monitored RecoveryPreop intervention Arm Referral to Perioperative Optimization of Senior Health (POSH) Program Remote patient monitoring device orientation, initial intake, and education UTSW ERAS protocol perioperatively Inpatient geriatrics co-management Monitored recovery Post-operative monitoring with Acticare for 90 days Post-op specialist continuity of care |
| Control Arm | Active comparator | Other: Usual CareEnhanced Recovery After Surgery Usual referral and recovery care as needed Standard follow-up protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults equal to or more than 18 years old
- Diagnosis of bladder cancer with plan to undergo radical cystectomy
- Agrees to participate in study procedures
Key exclusion criteria (2 listed)
- Patients undergoing cystectomy for diagnosis other than bladder cancer
- Do not provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preop Intervention and Monitored RecoveryAlso: Monitored recovery during post-operative phasePerioperative Optimization of Senior Health (POSH) Program; patient monitoring by device orientation, initial intake, education; ERAS protocol, inpatient geriatric co-management; and remote monitoring with Acticare device; post-op continuity of care | Other | Intervention Arm |
| Usual CareERAS, Usual referral and recovery care, and Standard follow-up protocol | Other | Control Arm |
Primary outcome
90 day complication rate
Time frame: 90 days
Number of occurrences of complications at 90 days in patients in post-operative phase
5 secondary outcomes
30 day complication rate
Time frame: 30 days
Readmission rates
Time frame: 90 days
Adherence to the intervention
Time frame: 90 days
Changes in functional fitness as measured by step count
Time frame: Baseline, 90 days
QOL changes as measured by the Bladder Cancer Index and FACT-Bl-Cys Questionnaire measures
Time frame: Baseline, 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- 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.
Yair Lotan, MD principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Preop Intervention and Monitored Recovery in people with Bladder Cancer and Radical Cystectomy, run by University of Texas Southwestern Medical Center.
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 3 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: withdrawn, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
90 day complication rate (time frame: 90 days). 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 27 May 2026.