Intensified Post-Surgery Monitoring for Cancer Surgery Recovery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if close monitoring after cancer surgery improves patient recovery compared to standard check-ups. Participants will receive either standard follow-up care or intensified post-discharge surveillance to detect complications early. The trial seeks individuals who have undergone major elective surgery for cancer, such as tumors in the head, neck, chest, or abdomen. It may suit those with a scheduled surgery to treat known or suspected cancer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in post-surgical cancer care.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that closely monitoring patients after cancer surgery is safe. By using patient feedback and data from wearable devices, doctors can effectively track recovery, including hospital visits and overall progress for up to 90 days post-discharge. This monitoring method has not reported any major safety issues.
Additionally, wearable sensors help monitor patients without frequent hospital visits. Studies have explored this approach and found no significant risks or negative effects. The goal is to ensure patients recover well at home, with support from technology.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new approach to monitoring recovery after cancer surgery. Unlike the standard post-discharge care, which provides typical follow-up, the intensified surveillance in this trial involves more frequent and detailed monitoring for complications, hospital readmissions, and quality of life over a longer period. This approach could lead to earlier detection of issues, potentially improving recovery outcomes and overall patient well-being.
What evidence suggests that intensified post-discharge surveillance is effective for cancer surgery recovery?
Research has shown that closely monitoring patients after they leave the hospital can greatly improve recovery following cancer surgery. In this trial, participants in the Intervention Arm will receive intensified post-discharge surveillance. This approach aims to lower the chances of complications and reduce hospital readmissions by carefully monitoring patients' health after surgery. One study found that patients with recurrent colorectal cancer who had more frequent check-ups had a 5-year survival rate of 32%, compared to only 13% for those with fewer check-ups. Another study suggested that closer monitoring could reduce the risk of complications by 7%. These findings highlight the benefits of increased attention to patients' recovery after surgery.12678
Who Is on the Research Team?
Jason Castellanos, MD
Principal Investigator
Fox Chase Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo elective major cancer surgery and are randomized to either standard or intensified post-discharge surveillance
Post-Discharge Surveillance
Participants are monitored for postoperative deaths, complications, and adverse events through PDD 30, and for hospital readmission, QOL, and receipt of anti-neoplastic therapy through PDD 90
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intensified post-discharge surveillance
- Standard post-discharge surveillance
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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
Patients in the Control Arm will receive standard post-discharge surveillance (i.e., usual care).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fox Chase Cancer Center
Lead Sponsor
Citations
Intensified surveillance after surgery for colorectal cancer ...
The 5-year survival rates for patients with a recurrent disease was 32% (intensive), 13% (minimal) and 19% (none), respectively with statistically significant ...
Study Details | NCT05454280 | Post-Discharge Risk-Based ...
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 ...
Enhancing Quadruple Health Outcomes After Thoracic Surgery
Our quadruple health outcome measurement strategy included (1) postoperative outcomes like 30-day ED visits, 30-day RRs, postoperative ...
Predicting Post-Discharge Cancer Surgery Complications ...
We explored the potential added value of patient reported outcomes (PROs) and patient generated health data (PGHD) for the task of predicting post-discharge ...
5.
researchgate.net
researchgate.net/publication/395037078_Comparative_effectiveness_of_remote_perioperative_telemonitoring_in_cancer_surgery_a_randomized_trial(PDF) Comparative effectiveness of remote perioperative ...
This randomized trial compared remote perioperative telemonitoring (RPM) care versus surgeon only. care in patients with gastrointestinal ...
Comparative effectiveness of remote perioperative ...
All outcomes were captured at baseline (before surgery) and at days 7, 14, 30, 60, and 90 post-hospital discharge. Functional recovery was ...
Machine Learning for Postoperative Continuous Recovery ...
This model provides a novel automated technique for monitoring post-operative recovery with the use of data from wearable sensors. The proposed ...
8.
researchgate.net
researchgate.net/publication/371068866_Monitoring_Patient-Reported_Outcomes_in_Self-management_of_Postsurgical_Symptoms_in_OncologyMonitoring Patient-Reported Outcomes in Self ...
Objective: To map the PROs used for patients' postsurgical symptom self-management after hospital discharge following cancer surgery.
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