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Trial Title:
Comprehensive Optimization At-time of Radical Cystectomy Intervention
NCT ID:
NCT05714826
Condition:
Bladder Cancer
Radical Cystectomy
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Peri-operative
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Preop Intervention and Monitored Recovery
Description:
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
Arm group label:
Intervention Arm
Other name:
Monitored recovery during post-operative phase
Intervention type:
Other
Intervention name:
Usual Care
Description:
ERAS, Usual referral and recovery care, and Standard follow-up protocol
Arm group label:
Control Arm
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390-9164
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sonobia Garrett
Phone:
214-645-8482
Email:
Sonobia.Garrett@UTSouthwestern.edu
Contact backup:
Last name:
Holly L Ford
Phone:
2146458790
Email:
holly.ford@utsouthwestern.edu
Start date:
April 25, 2024
Completion date:
August 24, 2026
Lead sponsor:
Agency:
University of Texas Southwestern Medical Center
Agency class:
Other
Source:
University of Texas Southwestern Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05714826
