Comprehensive Optimization At-time of Radical Cystectomy Intervention

NCT05714826 | Recruiting DMC

• 1 other identifier: STU-2022-1221
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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

Keywords

Peri-operative

Outcome Measures

Primary Outcomes (1)

• 90 day complication rate

  Number of occurrences of complications at 90 days in patients in post-operative phase

  90 days

Secondary Outcomes (5)

• 30 day complication rate

  30 days

• Readmission rates

  90 days

• Adherence to the intervention

  90 days

• Changes in functional fitness as measured by step count

  Baseline, 90 days

• QOL changes as measured by the Bladder Cancer Index and FACT-Bl-Cys Questionnaire measures

  Baseline, 90 days

Study Arms (2)

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

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

Other: Usual Care

Interventions

Preop Intervention and Monitored Recovery OTHER

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

Also known as: Monitored recovery during post-operative phase

Intervention Arm

Usual Care OTHER

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

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9164, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Yair Lotan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Taylor, MD, MPH

CONTACT

781-789-7047; Jacob.Taylor@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: April 25, 2024
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): August 24, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)