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)

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Surgery
• Intervention / Treatment: Procedure: Standard post-discharge surveillance; Procedure: Intensified post-discharge surveillance

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

• Study Type: Interventional
• Enrollment (Estimated): 880
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jason Castellanos, MD; Phone Number: 215-728-3518; Email: Jason.Castellanos@fccc.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111-2497
      • Recruiting
      • Fox Chase Cancer Center - Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

First Registration Inclusion Criteria:

• Age > 18 years at diagnosis
• ECOG performance status 0, 1, or 2, defined as

Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours

   • Patients must have probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage).

Patients undergoing major operations to resect or treat known or suspected malignancies of the head and neck, chest, abdomen, genitourinary tract, or extremities are eligible. Patients undergoing biopsies, outpatient procedures, superficial resections of cutaneous malignancies, or purely palliative operations are not eligible.

These procedures are commonly performed in patients with malignant neoplasms, malignant neuroendocrine tumors, or carcinomas in situ, and are commonly "tracked" by hospitals and cancer centers participating in the ACS NSQIP Procedure Targeted option because they are often associated with higher rates of postoperative morbidity and mortality (compared to other, less complex cancer procedures).

• Patient must be scheduled for elective major cancer surgery (as listed in 4.1.4) at FCCC < 30 days after First Registration.

Elective surgery is defined as:

• Patient is scheduled to be brought from their home (or normal living environment) to FCCC on the day of the index surgery (or day prior as scheduled admission) AND

• Surgery is not scheduled as urgent or emergent

  • Ability to understand and willingness to sign a written informed consent and HIPAA consent document
  • Geographical accessibility and willingness to return to FCCC for all preoperative and postoperative study assessments.

First Registration Exclusion Criteria:

• Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.

Second Registration Inclusion Criteria:

A patient will be eligible for continued inclusion in this study only if ALL of the following criteria apply at the time of Second Registration (one to two days prior to anticipated discharge). No exceptions or waivers will be granted for patients who do not meet the eligibility criteria.

• Post

  • Elective (curative or palliative) major cancer surgery (as listed in 4.1.4 above) at the time of the index surgery (patient may have undergone more than one of these procedures) OR
  • Elective surgical procedure(s) listed as an option (i.e., CPT code) in the Surgical Risk Calculator webpage (patient may have undergone more than one of these procedures)

For the purposes of this study, the procedure that was performed with the highest estimated risk of DSC (as predicted by the Surgical Risk Calculator) will be denoted at the time of Second Registration as the "index procedure" performed during the "index surgery".

• Elective surgery < 30 days after First Registration.

Second Registration Exclusion Criteria:

• Status post elective surgical procedure(s) not listed as options in the Surgical Risk Calculator webpage. This includes patients whose scheduled procedure was suspended due to unexpected findings, such as carcinomatosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm: Standard Perioperative Management; Patients in the Control Arm will receive standard post-discharge surveillance (i.e., usual care).	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.
Experimental: Intervention Arm: Intensified Post-Discharge Surveillance; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day rate of readmission/visit to emergency department/death	The primary objective of this trial is to determine if intensified post-discharge surveillance leads to a 7% absolute risk reduction/35% relative risk reduction in the composite endpoint of 30-day rate of readmission/visit to emergency department/death compared to standard post discharge management in patients undergoing elective, high risk cancer operations.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day rate of death	Secondary objectives of the study are to determine whether intensified post-discharge surveillance leads to a reduction in 30-day rate of death	30 days
30-day rate of hospital readmission after index surgery	Secondary objectives of the study are to determine whether intensified post-discharge surveillance leads to a reduction in 30-day rate of hospital readmission after index surgery	30 days
60-day rate of hospital readmission after index surgery	Secondary objectives of the study are to determine whether intensified post-discharge surveillance leads to a reduction in 60-day rate of hospital readmission after index surgery	60 days
90-day rate of hospital readmission after index surgery	Secondary objectives of the study are to determine whether intensified post-discharge surveillance leads to a reduction in 90-day rate of hospital readmission after index surgery	90 days
30-day rate of unplanned Emergency Department visits	Secondary objectives of the study are to determine whether intensified post-discharge surveillance leads to a reduction in 30-day rate of unplanned Emergency Department visits	30 days

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Investigators: Principal Investigator: Jason Castellanos, MD, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2022
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 22-1013; SURG-210 (Other Identifier: Fox Chase Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No