Intensified Post-Surgery Monitoring for Cancer Surgery Recovery

Overseen By Jason Castellanos, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Fox Chase Cancer Center

Disqualifiers: Biopsies, Outpatient procedures, Superficial resections, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Index hospitalization

880 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

I can take care of myself and perform daily activities.

I have a confirmed diagnosis of cancer or a tumor.

Ability to understand and willingness to sign a written informed consent and HIPAA consent document

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

I have had surgery that is not listed on the Surgical Risk Calculator website.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo elective major cancer surgery and are randomized to either standard or intensified post-discharge surveillance

Index hospitalization

In-hospital stay

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

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Intervention Arm: Intensified Post-Discharge Surveillance Experimental Treatment 1 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 Management Active Control 1 Intervention

Patients in the Control Arm will receive standard post-discharge surveillance (i.e., usual care).

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3351844/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05454280

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 ...

3. periop.jmir.org periop.jmir.org/2025/1/e58998

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8764868/

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 ...

6. nature.com nature.com/articles/s41746-025-01961-z

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 ...

7. mdpi.com mdpi.com/1424-8220/23/9/4455

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_Oncology

Monitoring Patient-Reported Outcomes in Self ... Objective: To map the PROs used for patients' postsurgical symptom self-management after hospital discharge following cancer surgery.