Pre and Post-Operative Optimization Program to Lower Post-Radical Cystectomy Complications in Patients with Bladder Cancer, COARC Trial

PRIMARY OBJECTIVE:

I. To determine if a comprehensive patient optimization program around time of radical cystectomy using remote patient monitoring decreases 90 day post-operative complications rates.

SECONDARY OBJECTIVES:

I. To measure differences in 30 day post-operative complications rates between the patients in the intervention and control groups.

II. To compare rates of readmission after surgery in the COARC intervention group compared to controls.

III. To determine adherence to the COARC intervention as measured by proportion of patients evaluated by Perioperative Optimization of Senior Health Program (POSH) and Physical Medicine and Rehabilitation (PM&R) pre and perioperatively, percentage of post-operative vital sign measurement entries.

IV. To measures changes in physical function measures (step count, 6-minute [min] walk tests, 5x sit-to-stand, hand grip strength test) pre and post-operatively in the COARC intervention group.

V. To measure changes in patient reported outcome survey measures (Functional Assessment of Cancer Therapy-Bladder-Cystectomy [FACT-Bl-Cys], Bladder Cancer Index [BCI], Katz-activities of daily living [KATZ-ADL]).

OUTLINE: Patients are randomized to 1 of 2 groups.

PART I-PRE-OPERATIVE PERIOD:

COARC GROUP: Patients under 60 years of age receive referral to PM&R and undergo a physical function assessment. Patients also meet with physical therapist and receive education on at home exercises. Patients may receive referral for formal prehab. Patients over 60 years of age receive referral to the POSH program and undergo a comprehensive geriatric assessment. Patients may receive referrals for additional consultations. All patients receive referral to a nutritionist and a remote patient monitoring (RPM) iPad to track vital signs once per week.

USUAL CARE GROUP: Patients undergo standard of care pre-operative clearance and referrals to other consultants per provider discretion. Patients receive general recommendations regarding diet, exercise, and smoking cessation (if current smoker).

PART II-PERIOPERATIVE PERIOD:

COARC GROUP: Patients over 60 years of age receive post-operative co-management from POSH team. All patients undergo standard of care Enhanced Recovery After Surgery (ERAS) bladder cancer protocol post radical cystectomy.

USUAL CARE GROUP: Patients undergo standard of care ERAS bladder cancer protocol post radical cystectomy.

PART III-POST-OPERATIVE PERIOD:

COARC GROUP: Patients use the RPM iPad to input vital signs, weight, and pedometer 3 times per week and as needed for up to 90 days post radical cystectomy. Patients receive post-operative care reminders throughout post-op period.

USUAL CARE GROUP: Patients receive standard of care follow-up after surgery including post-operative clinic appointments 1-2 weeks after discharge and recommendations about diet and exercise.