Recruiting

COARC Intervention

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05714826

Conditions

Bladder Cancer

Radical Cystectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Preop Intervention and Monitored Recovery

Usual Care

Study Details

Brief 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. 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.

Conditions

Bladder Cancer

Radical Cystectomy

Study ID

NCT05714826

Start date

Apr 25, 2024

Status verified date

Apr, 2025

Completion date

Aug 24, 2026

Anticipated

Primary completion date

May 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients undergoing cystectomy for diagnosis other than bladder cancer
  • Do not provide informed consent

Study Design

Enrollment

194 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

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

active comparator: Control Arm

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

Interventions

Preop Intervention and Monitored Recovery

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 Care

ERAS, Usual referral and recovery care, and Standard follow-up protocol

Primary outcome measure

  • 90 day complication rate [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-9164

Contacts

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

May 2, 2025

Last verified

Apr, 2025

Keywords

  • Peri-operative

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-05-02.