COARC: Comprehensive Optimization At-time of Radical Cystectomy Intervention

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05714826

Collaborator

(none)

194

Enrollment

Arms

41.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Radical Cystectomy	Other: Preop Intervention and Monitored Recovery Other: Usual Care	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

Comprehensive Optimization At-time of Radical Cystectomy Intervention Through Peri-operative Patient Care Program

Anticipated Study Start Date :

Feb 25, 2023

Anticipated Primary Completion Date :

Feb 25, 2026

Anticipated Study Completion Date :

Aug 24, 2026

Arms and Interventions

Arm	Intervention/Treatment
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	Other: 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 Other Names: Monitored recovery during post-operative phase
Active Comparator: Control Arm Enhanced Recovery After Surgery Usual referral and recovery care as needed Standard follow-up protocol	Other: Usual Care ERAS, Usual referral and recovery care, and Standard follow-up protocol

Arm

Intervention/Treatment

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

Other: 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

Other Names:

Monitored recovery during post-operative phase

Active Comparator: Control Arm

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

Other: Usual Care

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

Outcome Measures

Primary Outcome Measures

90 day complication rate [90 days]
Number of occurrences of complications at 90 days in patients in post-operative phase

Secondary Outcome Measures

30 day complication rate [30 days]
Number of occurrences of complications at 30 days in patients in post-operative phase
Readmission rates [90 days]
Number of readmissions
Adherence to the intervention [90 days]
It is assessed via patient-self report measure
Changes in functional fitness as measured by step count [Baseline, 90 days]
Changes in functional fitness will be measured by step count
Changes in Quality of Life (QOL) [Baseline, 90 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator: Yair Lotan, MD, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

yair lotan, Professor, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT05714826

Other Study ID Numbers:

STU-2022-1221

First Posted:

Feb 6, 2023

Last Update Posted:

Feb 6, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by yair lotan, Professor, University of Texas Southwestern Medical Center

Peri-operative

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Study Results

No Results Posted as of Feb 6, 2023