NCT05454280

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 880 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Surgery
• Cancer

Interventions

Type	Name	Description
PROCEDURE	Intensified post-discharge surveillance	* TCC Nurse Televisit at post-discharge day 1 and 7 * Televisit with APP/Resident/Fellow between post-discharge day 3-5 * Referral for home health nursing evaluation upon discharge
PROCEDURE	Standard post-discharge surveillance	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.

Timeline

• Start date: 2022-10-14
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2022-07-12
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States