Optimized Care for Bladder Cancer

(COARC Trial)

Overseen By Jacob Taylor, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Non-bladder cancer, No consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

194 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Preop Intervention and Monitored Recovery for bladder cancer?

Research shows that using an Enhanced Recovery After Surgery (ERAS) protocol, which is similar to Preop Intervention and Monitored Recovery, can improve survival rates and reduce hospital stay after bladder cancer surgery. ^{1 2 3 4 5}

Is the Optimized Care for Bladder Cancer treatment generally safe for humans?

The Enhanced Recovery After Surgery (ERAS) protocol, which is part of the Optimized Care for Bladder Cancer treatment, has been shown to decrease postoperative complications and improve recovery in patients undergoing surgery for bladder cancer, suggesting it is generally safe for humans. ^{5 6 7 8 9}

How is the Preop Intervention and Monitored Recovery treatment for bladder cancer different from other treatments?

This treatment is unique because it focuses on preoperative optimization and monitored recovery, combining nutritional evaluation, prehabilitation (pre-surgery preparation), and enhanced recovery protocols to improve outcomes for bladder cancer surgery. It aims to reduce complications and improve recovery by preparing patients better before surgery and closely monitoring them afterward. ^{10 11 12 13 14}

Research Team

Yair Lotan, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

Adults 18 years or older with bladder cancer who are planning to undergo radical cystectomy can participate. They must agree to follow the study procedures, which include a comprehensive optimization strategy before, during, and after surgery.

Inclusion Criteria

I have bladder cancer and am planning to have my bladder removed.

Agrees to participate in study procedures

Exclusion Criteria

I am having bladder removal surgery for a reason other than bladder cancer.

Do not provide informed consent

Timeline

Pre-operative

Participants undergo nutritional, functional, and global health assessment and receive remote patient monitoring device orientation

2-4 weeks

1 visit (in-person), weekly remote monitoring

Perioperative

Participants undergo standard of care Enhanced Recovery After Surgery (ERAS) protocol and receive inpatient geriatrics co-management

Hospital stay

Inpatient

Post-operative

Participants are monitored for 90 days post-operatively using remote patient monitoring to track vital signs and step count

90 days

Remote monitoring 3x/week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Preop Intervention and Monitored Recovery
• Usual Care

Trial Overview The trial is testing a multi-modal approach called COARC that optimizes patient care at all stages of radical cystectomy for bladder cancer. It includes pre-op intervention and monitored recovery versus usual care, aiming to reduce post-surgery complications.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

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

Group II: Control Arm Active Control 1 Intervention

Enhanced Recovery After Surgery Usual referral and recovery care as needed Standard follow-up protocol

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

Shortened inpatient length of stay (LOS) after radical cystectomy (RC) is linked to a higher risk of major outpatient complications, with 18.1% of patients experiencing complications compared to 11.2% in those with a routine LOS.

Patients discharged early (s-LOS) also showed a significant increase in hospital readmissions, indicating that while shorter stays may be desirable, they could lead to more complications and necessitate better outpatient support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Implications of Shortening Length of Stay Following Radical Cystectomy in a Pre-ERAS Population. Osawa, T., Ambani, SN., Olugbade, K., et al.[2022]

In a study of radical cystectomy for bladder cancer involving multiple hospitals in Sweden, the overall reoperation rate was 24%, with higher rates observed in patients who underwent continent urinary diversion compared to those with ileal conduit.

Despite higher mean blood loss in high-volume hospitals, the 90-day mortality rates were similar across hospitals, indicating that surgical volume did not significantly impact short-term mortality or cancer-specific survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up after radical cystectomy with emphasis on complications and reoperations: a Swedish population-based survey. Liedberg, F., Holmberg, E., Holmäng, S., et al.[2022]

In a study of 31 patients undergoing radical cystectomy, age and comorbidity indices (CCI and ACCI) were significantly associated with early postoperative complications, indicating that these factors should be carefully considered before surgery.

Patients with lower preoperative serum albumin levels experienced higher postoperative mortality, suggesting that evaluating nutritional status prior to surgery could be crucial for improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of preoperative clinical variables on the 30- and 90-day morbidity and mortality after radical cystectomy: A single-centre study. Mursi, K., ElFayoumy, H., Saad, I., et al.[2022]

The implementation of an enhanced recovery protocol for radical cystectomy significantly reduced the average hospital stay from 10 days to 7.1 days without increasing the overall readmission rates within 30 days.

While the protocol led to fewer readmissions for wound and deep space infections (decreasing from 42.9% to 23.4%), it was associated with a notable increase in urinary tract infection-related readmissions, rising from 14.3% to 40.4%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Radical Cystectomy Care Pathway on Postoperative Length of Stay and Outcomes. Brockman, JA., Vetter, J., Peck, V., et al.[2018]

In a study of 107 bladder cancer patients who underwent radical cystectomy, those managed under the Enhanced Recovery After Surgery (ERAS®) protocol had a significantly higher five-year cancer-specific survival rate of 74% compared to 48% in the control group.

The ERAS® protocol also improved overall survival rates by 31%, indicating that this approach not only enhances recovery but may also positively influence long-term outcomes after major surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ERAS® protocol improves survival after radical cystectomy: A single-center cohort study. Crettenand, F., M'Baya, O., Grilo, N., et al.[2022]

In a study of 383 bladder cancer patients undergoing radical cystectomy, those treated with Enhanced Recovery After Surgery (ERAS) methods reported significantly less pain, drowsiness, dry mouth, disturbed sleep, and interference with functioning compared to those receiving traditional care.

The findings indicate that ERAS practices can effectively reduce immediate postoperative symptom burden, highlighting the importance of patient-reported outcomes in evaluating perioperative care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes Are Associated With Enhanced Recovery Status in Patients With Bladder Cancer Undergoing Radical Cystectomy. Kukreja, JB., Shi, Q., Chang, CM., et al.[2019]

In a study of 3113 patients undergoing radical cystectomy for bladder cancer, the use of neoadjuvant chemotherapy (NAC) did not increase the risk of post-operative complications compared to those who had surgery without prior chemotherapy, with similar rates of overall and major complications.

The analysis showed a significant increase in NAC utilization from 11.1% in 2007 to 41.2% in 2019, suggesting that NAC can be safely integrated into treatment protocols to enhance oncologic outcomes without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant chemotherapy does not increase peri-operative morbidity following radical cystectomy. Arora, A., Zugail, AS., Pugliesi, F., et al.[2022]

In a study of 150 patients undergoing radical cystectomy, the implementation of an Enhanced Recovery After Surgery (ERAS) protocol significantly reduced early and 90-day postoperative complications compared to traditional care, indicating its efficacy in improving surgical outcomes.

The ERAS protocol did not lead to a significant difference in 90-day readmission rates or length of hospital stay, suggesting that while it improves recovery, it may not shorten hospitalization time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Recovery after Surgery for Radical Cystectomy Decreases Postoperative Complications at Different Times. Lannes, F., Walz, J., Maubon, T., et al.[2022]

In a study of 102 patients undergoing cystectomy and/or urinary diversion, those with benign conditions had lower completion rates of the enhanced recovery after surgery (ERAS) protocols, which was linked to longer hospital stays and higher complication rates.

Higher administration of ERAS protocol items was associated with shorter hospitalizations and fewer complications, suggesting that tailored ERAS protocols for specific patient populations could improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Recovery After Surgery in the Urinary Diversion Population: Are Protocols Applied Differently in the Benign Indication Population? Shumaker, L., Nocera, A., Selph, P.[2022]

A comprehensive prehabilitation program for patients undergoing radical cystectomy was successfully implemented, with 82 patients enrolled, showing high adherence rates to nutritional screening and supplements (100% and 82%, respectively).

The program led to a reduction in resource length of stay (RLOS) and had a modest impact on postoperative complications, with 30-day and 30- to 90-day complication rates of 56% and 40%, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a comprehensive prehabilitation program for patients undergoing radical cystectomy. Smelser, WW., Tallman, JE., Gupta, VK., et al.[2023]

Surgeons should use a multidisciplinary and evidence-based approach to preoperative care for radical cystectomy to improve patient outcomes.

Implementing early recovery after surgery protocols and personalized prehabilitation plans is essential for minimizing perioperative risks and improving the quality of life after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Prehabilitation: A Pragmatic Guide. Drevik, J., Michel, C., Hamilton-Reeves, J.[2023]

Radical cystectomy (RC) has high rates of complications and mortality, prompting a focus on preoperative optimization strategies to improve patient outcomes.

Current literature suggests that comprehensive nutritional evaluation, supplementation, and prehabilitation may help reduce the risks associated with RC, beyond standard enhanced recovery protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative optimization of the radical cystectomy patient: Current state and future directions. Ellis, JL., Dalimov, Z., Chew, L., et al.[2023]

Enhanced recovery protocols (ERAS) can significantly improve outcomes for patients undergoing radical cystectomy for muscle-invasive urothelial carcinoma by reducing gastrointestinal complications and shortening hospital stays.

Implementing ERAS principles does not lead to increased readmissions or overall morbidity, highlighting their safety and efficacy in enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Recovery After Surgery Pathways: Role and Outcomes in the Management of Muscle Invasive Bladder Cancer. Zainfeld, D., Shah, A., Daneshmand, S.[2018]

Nursing plays a crucial role in the Enhanced Recovery After Surgery (ERAS) program for patients undergoing radical cystectomy for advanced bladder cancer, emphasizing the need for skilled discharge planning and collaboration with primary care and family support.

The establishment of nurse-led prehabilitation academies and the shift towards proactive interventions in the surgical pathway highlight the importance of integrating patient and family involvement in treatment decisions, which is increasingly mandated by healthcare policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organization Factors in the ERAS Bladder Cancer Pathway: The Multifarious Role of the ERAS Nurse, Why and What Is Important? Jensen, BT.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Potential Implications of Shortening Length of Stay Following Radical Cystectomy in a Pre-ERAS Population. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Long-term follow-up after radical cystectomy with emphasis on complications and reoperations: a Swedish population-based survey. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of preoperative clinical variables on the 30- and 90-day morbidity and mortality after radical cystectomy: A single-centre study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of a Radical Cystectomy Care Pathway on Postoperative Length of Stay and Outcomes. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

ERAS® protocol improves survival after radical cystectomy: A single-center cohort study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes Are Associated With Enhanced Recovery Status in Patients With Bladder Cancer Undergoing Radical Cystectomy. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Neoadjuvant chemotherapy does not increase peri-operative morbidity following radical cystectomy. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Enhanced Recovery after Surgery for Radical Cystectomy Decreases Postoperative Complications at Different Times. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Enhanced Recovery After Surgery in the Urinary Diversion Population: Are Protocols Applied Differently in the Benign Indication Population? [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Implementation of a comprehensive prehabilitation program for patients undergoing radical cystectomy. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Nutritional Prehabilitation: A Pragmatic Guide. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Preoperative optimization of the radical cystectomy patient: Current state and future directions. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Enhanced Recovery After Surgery Pathways: Role and Outcomes in the Management of Muscle Invasive Bladder Cancer. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Organization Factors in the ERAS Bladder Cancer Pathway: The Multifarious Role of the ERAS Nurse, Why and What Is Important? [2021]