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

NCT05454280 | Recruiting Phase 3 DMC

• 2 other identifiers: 22-1013SURG-210
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgery; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 30-day rate of death

  30 days

• 30-day rate of hospital readmission after index surgery

  30 days

• 60-day rate of hospital readmission after index surgery

  60 days

• 90-day rate of hospital readmission after index surgery

  90 days

• 30-day rate of unplanned Emergency Department visits

  30 days

Study Arms (2)

Control Arm: Standard Perioperative Management

ACTIVE COMPARATOR

Patients in the Control Arm will receive standard post-discharge surveillance (i.e., usual care).

Procedure: Standard post-discharge surveillance

Intervention Arm: Intensified Post-Discharge Surveillance

EXPERIMENTAL

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

Interventions

Intensified post-discharge surveillance PROCEDURE

* 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

Intervention Arm: Intensified Post-Discharge Surveillance

Standard post-discharge surveillance PROCEDURE

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.

Control Arm: Standard Perioperative Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jason Castellanos, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Castellanos, MD

CONTACT

215-728-3518; Jason.Castellanos@fccc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: October 14, 2022
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)