Clinical trial NCT05714826: Comprehensive Optimization At-time of Radical Cystectomy Intervention
Official title: Comprehensive Optimization At-time of Radical Cystectomy Intervention Through Peri-operative Patient Care Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Radical Cystectomy
Keywords: Peri-operative
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 90 day complication rate
timeFrame: 90 days
Secondary outcomes:
measure: 30 day complication rate
timeFrame: 30 days
measure: Readmission rates
timeFrame: 90 days
measure: Adherence to the intervention
timeFrame: 90 days
measure: Changes in functional fitness as measured by step count
timeFrame: Baseline, 90 days
measure: QOL changes as measured by the Bladder Cancer Index and FACT-Bl-Cys Questionnaire measures
timeFrame: Baseline, 90 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Yair Lotan, MD
role: PRINCIPAL_INVESTIGATOR
References: