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Post-Discharge Risk-Based Management for Cancer Surgery Patients

This study is for adults undergoing major cancer surgery. It compares two ways of monitoring patients after they leave the hospital: intensified surveillance versus standard care. Intensified surveillance includes phone calls from a nurse and an advanced practice provider (APP), and a referral for home health nursing. Standard care is determined by your surgeon. The main goal is to see if intensified surveillance can reduce the number of times patients are readmitted to the hospital, visit the emergency room, or die within 30 days after surgery. You may be eligible if you are over 18, have cancer, and have a good performance status (meaning you are able to do most of your daily activities). The study plans to enroll 880 participants.

Study design
This is a randomized study, meaning participants are assigned by chance to either intensified or standard post-discharge surveillance. It plans to enroll 880 participants.
What's involved
Participants will receive either intensified post-discharge surveillance (televisits, home health referral) or standard surveillance. You will be monitored for complications and readmissions for up to 90 days after discharge.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 30 days for readmission, emergency room visits, or death, and for 90 days for hospital readmission, quality of life, and cancer treatment.

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NCT05454280

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Fox Chase Cancer Center
~880 participants
Updated 2025-07-08 on ClinicalTrials.gov
What's tested:Intensified post-discharge surveillanceStandard post-discharge surveillance

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
30-day rate of readmission/visit to emergency department/death
Measured over 30 days

Conditions

Surgery
Cancer

Explore related trials

Malignant Neoplasm

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Jason Castellanos, MD · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center

Who to contact

Jason Castellanos, MD
[email protected]
215-728-3518
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \> 18 years at diagnosis
ECOG performance status 0, 1, or 2, defined as
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).
Patient must be scheduled for elective major cancer surgery (as listed in 4.1.4) at FCCC \< 30 days after First Registration.
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.
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)
Elective surgery \< 30 days after First Registration.

Exclusion

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.
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.

What this trial measures

  • 30-day rate of readmission/visit to emergency department/death30 days

    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.