Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)

Cancer Clinical Trial

Official title: A Randomized Controlled Trial of Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)

Status Recruiting

Clinical Trial Summary

This is a randomized trial of intensified post-discharge surveillance (Intervention Arm) versus standard post-discharge surveillance (Control Arm).

Clinical Trial Description

Eligible adult patients with probable or histologically/cytologically confirmed, primary or recurrent, malignant neoplasms (any stage) scheduled to undergo elective major cancer surgery at FCCC who meet eligibility criteria will be stratified by procedure type and randomized to the Intervention Arm or Control Arm.

• Prior to discharge, patients who meet eligibility criteria at Second Registration will be confirmed for study eligibility and randomized. Patients in the Control Arm will receive standard post-discharge surveillance, as deemed appropriate/necessary by the surgeons caring for them at the time of hospital discharge.

Patients in the Intervention and Control Arms will be monitored

• Through PDD 30 for postoperative deaths and complications (as defined by ACS NSQIP) and/or adverse events (as defined by CTCAE)

• Through the end of the index hospitalization for ICU admission, postoperative LOS, return to operating room, and discharge to home.

• Through PDD 90 for hospital readmission, QOL, and receipt of anti-neoplastic therapy ;

Related Conditions & MeSH terms

• Cancer
• Surgery

• NCT number: NCT05454280
• Study type: Interventional
• Source: Fox Chase Cancer Center
• Contact: Jason Castellanos, MD
• Phone: 215-728-3518
• Email: Jason.Castellanos@fccc.edu
• Status: Recruiting
• Phase: Phase 3
• Start date: October 14, 2022
• Completion date: November 1, 2028