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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and perform daily activities.I have a confirmed diagnosis of cancer or a tumor.I was diagnosed with my condition after turning 18.I am having surgery to remove or treat cancer in a specific area.I am scheduled for major cancer surgery within 30 days.I have had surgery that is not listed on the Surgical Risk Calculator website.I can travel to and am willing to return to the study center for all required visits.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm: Standard Perioperative Management
- Group 2: Intervention Arm: Intensified Post-Discharge Surveillance
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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