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Intensified Post-Surgery Monitoring for Cancer Surgery Recovery

Phase 3
Recruiting
Led By Jason Castellanos, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0, 1, or 2
Patients must have probable or histologically/cytologically confirmed primary or recurrent malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial is testing whether intensified post-discharge surveillance helps people recover from COVID-19 better than standard post-discharge surveillance.

Who is the study for?
This trial is for adults over 18 with certain cancer types who are physically able to do light work or self-care and are scheduled for major elective cancer surgery. They must understand and agree to the study terms, live close enough to return for follow-ups, and not have any conditions that could affect their participation.Check my eligibility
What is being tested?
The study compares two ways of monitoring patients after they leave the hospital following high-risk cancer surgery: one group gets more intense check-ups while the other follows standard care. Patients will be randomly assigned to either group.See study design
What are the potential side effects?
Since this trial focuses on post-discharge surveillance rather than medication, there aren't direct side effects from treatments like drugs. However, intensified surveillance may lead to increased medical visits or interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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I have a confirmed diagnosis of cancer or a tumor.
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I am having surgery to remove or treat cancer in a specific area.
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I was diagnosed with my condition after turning 18.
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I am scheduled for major cancer surgery within 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
30-day rate of readmission/visit to emergency department/death
Secondary outcome measures
30-day rate of death
30-day rate of hospital readmission after index surgery
30-day rate of unplanned Emergency Department visits
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Arm: Intensified Post-Discharge SurveillanceExperimental Treatment1 Intervention
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
Group II: Control Arm: Standard Perioperative ManagementActive Control1 Intervention
Patients in the Control Arm will receive standard post-discharge surveillance (i.e., usual care).

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
36,629 Total Patients Enrolled
1 Trials studying Surgery
1,456 Patients Enrolled for Surgery
Jason Castellanos, MDPrincipal InvestigatorFox Chase Cancer Center

Media Library

Intensified post-discharge surveillance Clinical Trial Eligibility Overview. Trial Name: NCT05454280 — Phase 3
Surgery Research Study Groups: Control Arm: Standard Perioperative Management, Intervention Arm: Intensified Post-Discharge Surveillance
Surgery Clinical Trial 2023: Intensified post-discharge surveillance Highlights & Side Effects. Trial Name: NCT05454280 — Phase 3
Intensified post-discharge surveillance 2023 Treatment Timeline for Medical Study. Trial Name: NCT05454280 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA condone more intense monitoring after a patient leaves the hospital?

"There is some efficacy data and multiple rounds of safety data available for this phase 3 trial, so the Power team gave it a safety rating of 3."

Answered by AI

Is this a closed study or are there still positions available for volunteers?

"Unfortunately, this particular trial is no longer recruiting patients, as reflected in the posting on clinicaltrials.gov. The study was first made available on November 1st, 2020, but the most recent update was on October 5th, 2020. There are, however, 766 other trials that are still recruiting patients."

Answered by AI
~587 spots leftby Nov 2028