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| ID | Type | Description | Link |
|---|---|---|---|
| SURG-210 | Other Identifier | Fox Chase Cancer Center |
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This is a randomized trial of intensified post-discharge surveillance (Intervention Arm) versus standard post-discharge surveillance (Control Arm).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm: Standard Perioperative Management | Active Comparator | Patients in the Control Arm will receive standard post-discharge surveillance (i.e., usual care). |
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| Intervention Arm: Intensified Post-Discharge Surveillance | Experimental | Patients in the Intervention and Control Arms will be monitored
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensified post-discharge surveillance | Procedure |
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| 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 |
| 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 |
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First Registration Inclusion Criteria:
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 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).
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
First Registration Exclusion Criteria:
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
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".
Second Registration Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Castellanos, MD | Contact | 215-728-3518 | Jason.Castellanos@fccc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason Castellanos, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center - Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19111-2497 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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.
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| 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. |
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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 |