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

Launched by FOX CHASE CANCER CENTER · Jul 7, 2022

Keywords

ClinConnect Summary

The PRS II clinical trial is studying how to improve care for patients who have undergone major cancer surgeries. Researchers want to find out if more intensive follow-up after surgery—where doctors closely monitor patients—can lead to better outcomes compared to the standard follow-up care. This trial is currently looking for participants aged 18 and older who have been diagnosed with certain types of cancer and are scheduled to have elective major surgery. Eligible participants should be able to get around independently, even if they have some physical limitations.

If you decide to join the study, you will be randomly assigned to either the intensive follow-up group or the standard care group after your surgery. The goal is to see if the extra monitoring helps prevent complications and improves recovery. It’s important to know that this trial is specifically for patients undergoing significant surgeries related to cancers in areas like the head, neck, chest, or abdomen. Participants will need to return to the hospital for follow-up appointments after their surgery, and they must be willing to provide informed consent to take part in the study.

Gender

ALL

Eligibility criteria

• First Registration Inclusion Criteria:
• • 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
• • 1. 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
• • 2. 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.
• First Registration Exclusion Criteria:
• • 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.
• 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
• • 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.
• Second Registration Exclusion Criteria:
• • 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.