Risk-based Monitoring and Care for Surgery

(PRS Trial)

Overseen By John W Lee, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Must not be taking: Systemic chemotherapy

Disqualifiers: Benign tumors, Recent radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a personalized approach to care can reduce the risk of death or serious complications for individuals undergoing major cancer surgery. It compares standard care with a risk-based method, adjusting care and monitoring according to each patient's specific needs. This includes preoperative risk stratification, where patients are assessed before surgery to determine their risk levels. Suitable candidates have a history of cancer and are scheduled for elective major surgery, such as a prostatectomy or lung resection, at Fox Chase Cancer Center. Participants must be able to return to the center for all study-related visits. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance personalized care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using systemic chemotherapy or radiation therapy, you must stop at least 14 days before joining the trial.

What prior data suggests that this protocol is safe for perioperative management?

Research has shown that managing surgery based on individual risk levels is generally well-tolerated. Studies indicate that sorting patients by risk can improve surgical outcomes by tailoring care to each person's needs. This method has successfully been used in adults undergoing major cancer surgery.

Although specific data on safety issues is lacking, personalized care is believed to better manage potential complications. By focusing on individual risk, the treatment aims to reduce the chance of serious problems. Overall, the treatment appears promising, but personal experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a personalized approach to surgery care, which could improve outcomes for patients. Unlike the traditional one-size-fits-all method, this trial focuses on risk-based, escalating levels of care, monitoring, and co-management tailored to each patient's specific needs. By stratifying risks both before and after surgery, healthcare providers can adjust care levels dynamically, potentially reducing complications and improving recovery times. This innovative approach could lead to more efficient use of resources and better patient experiences compared to standard postoperative care.

What evidence suggests that risk-based perioperative management is effective for reducing death or serious complications in major cancer surgery?

This trial will compare standard perioperative management with risk-based perioperative management for patients undergoing major cancer surgery. Research has shown that managing care based on a patient's risk level can lead to better results. By grouping patients according to their risk, doctors can provide care tailored to each person's specific needs, reducing deaths and serious complications. For instance, one study found that patients who received this personalized care had better outcomes than those who received standard treatment. The goal is to identify and address potential issues early, aiding in safer and quicker recovery. This approach adjusts care based on each patient's unique risk factors, significantly improving recovery. ^{1 2 3 4 6}

Who Is on the Research Team?

Nestor F Esnaola, MD, MPH, MBA

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with confirmed or suspected malignant tumors, including various types of cancer surgeries (like lung resection, hysterectomy), who can visit Fox Chase Cancer Center for all study assessments. They should be fit enough for surgery (ECOG status 0-3) and not have had recent chemotherapy or radiation therapy.

Inclusion Criteria

Geographical accessibility and willingness to return to Fox Chase Cancer Center for all preoperative and postoperative study assessments

Probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage)

Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3

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

Use of systemic chemotherapy and/or radiation therapy less than 14 days prior to First Registration. Palliative radiation therapy is permitted for irradiating small areas of painful bony metastases that cannot be managed adequately using systemic or local analgesics

You have been diagnosed with a non-cancerous tumor or a tumor that is not clearly defined as cancerous or non-cancerous.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Risk Stratification

Participants undergo preoperative risk stratification to identify those at increased risk of postoperative complications

1-2 weeks

Surgery and Immediate Postoperative Care

Participants undergo elective major cancer surgery followed by immediate postoperative care

1 week

Postoperative Risk-based Management

Participants receive risk-based, protocol-driven management including escalating levels of care, monitoring, and co-management

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

What Are the Treatments Tested in This Trial?

Interventions

• Postoperative risk stratification
• Preoperative risk stratification
• Risk-based, escalating levels of care
• Risk-based, escalating levels of co-management
• Risk-based, escalating levels of monitoring
• Standard postoperative care

Trial Overview The study tests if a personalized risk assessment before and after surgery, followed by tailored levels of care and monitoring, can reduce death or serious complications compared to standard care in patients having major cancer surgery.

How Is the Trial Designed?

Group I: Risk-based, perioperative management Experimental Treatment 5 Interventions

Preoperative risk stratification Postoperative risk stratification Risk-based, escalating levels of care Risk-based, escalating levels of monitoring Risk-based, escalating levels of co-management

Group II: Standard perioperative management Active Control 1 Intervention

Standard postoperative care

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Published Research Related to This Trial

In a study of 3,807 surgical patients over 22 months, 30.9% experienced adverse events, with 6.9% of admissions linked to errors, highlighting a significant incidence of complications in surgical care.

Implementing continuous data collection on adverse events led to a reduction in error rates from 11.1% to 4.5%, demonstrating that systematic monitoring can enhance patient safety and quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous monitoring of adverse events: influence on the quality of care and the incidence of errors in general surgery. Rebasa, P., Mora, L., Luna, A., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39045699/

A Randomized, Controlled Trial Evaluating Perioperative ... Methods: Adults scheduled for elective major cancer surgery were stratified/randomized to risk-based escalating levels of care, monitoring, and ...

2. withpower.com withpower.com/trial/phase-neoplasms-7-2014-b1e7c

Risk-based Monitoring and Care for Surgery (PRS Trial) Research shows that risk stratification (sorting patients based on their risk levels) can help improve surgical outcomes by tailoring care to individual needs.

3. researchgate.net researchgate.net/publication/382522513_A_Randomized_Controlled_Trial_Evaluating_Perioperative_Risk-Stratification_and_Risk-Based_Protocol-Driven_Management_After_Elective_Major_Cancer_Surgery

A Randomized, Controlled Trial Evaluating Perioperative ... Methods Adults scheduled for elective major cancer surgery were stratified/randomized to risk-based escalating levels of care, monitoring, and ...

4. profiles.foxchase.org profiles.foxchase.org/en/publications/a-randomized-controlled-trial-evaluating-perioperative-risk-strat

A Randomized, Controlled Trial Evaluating Perioperative ... METHODS: Adults scheduled for elective major cancer surgery were stratified/randomized to risk-based escalating levels of care, monitoring, and comanagement ...

5. clinicalkey.com clinicalkey.com/#!/content/journal/1-s2.0-S0147956317303709?scrollTo=%23hl0000504

ClinicalKey

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28494887/

Preoperative risk stratification of critically ill patients This single center retrospective study quantified a high perioperative risk for critically ill patients with advanced airways: one in four did not survive ...