Perioperative Telemonitoring for Gastrointestinal Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Non-compliance with safety monitoring

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 explores whether at-home monitoring of health data can improve recovery after surgery for gastrointestinal cancer. Participants will use devices such as a digital scale, thermometer, and fitness watch to record their health information, which they will share with their medical team. This approach aims to catch potential issues early, reducing post-surgery complications. Individuals planning major abdominal surgery for gastrointestinal cancer who can use these devices might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-surgical recovery for future patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this telemonitoring program is safe for gastrointestinal cancer patients?

Research shows that remote monitoring, like that used in this trial, is generally safe for patients. Studies have found that this type of monitoring helps cancer surgery patients recover better without causing harm. A recent study showed that using devices to track health data at home is easy and safe. These devices, such as activity trackers and apps, are already popular and safe for everyday use.

Overall, remote monitoring in healthcare has shown positive results, improving symptoms and quality of life without significant risks. Patients generally accept it well, and it usually does not cause any side effects. Based on current evidence, joining a trial with remote monitoring is considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of telemonitoring and enhanced usual care to improve recovery for gastrointestinal cancer patients. Unlike traditional post-surgery care, which often relies on periodic in-person visits, telemonitoring allows real-time tracking of vital signs and activity levels using devices like the Vivofit 4 and home monitoring tools. This approach can help healthcare teams identify and address complications early, potentially improving patient outcomes. Enhanced usual care includes structured symptom and quality of life assessments, which could provide a more comprehensive understanding of each patient's recovery process. These innovations may lead to more personalized and effective care strategies for patients undergoing surgery for gastrointestinal cancer.

What evidence suggests that this telemonitoring program is effective for gastrointestinal cancer surgery recovery?

Research has shown that telemonitoring can greatly aid patients recovering from gastrointestinal cancer surgery. In this trial, participants in the telemonitoring arm will have their vital signs and symptoms monitored in real-time, improving recovery management. Studies have found that remote monitoring systems can detect changes in vital signs and patient well-being. Patients using telemonitoring report fewer symptoms and better recovery compared to those without it. Additionally, one study found that these systems reduced the risk of hospital readmission. Overall, telemonitoring supports better health outcomes by closely monitoring patients' conditions after surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Laleh Melstrom

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who can read English or Spanish, understand and consent to participate. It's aimed at patients with gastrointestinal cancers of any stage, scheduled for major abdominal surgeries like esophagectomy or gastrectomy. There are no restrictions on performance status or life expectancy.

Inclusion Criteria

All subjects must have the ability to understand and the willingness to sign a written informed consent

My condition applies to any stage of the disease.

I can read and understand either English or Spanish.

Exclusion Criteria

Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-surgery Monitoring

Participants complete questionnaires and health assessments using at-home monitoring devices up to 7 days before surgery

1 week

Remote monitoring

Post-surgery Telemonitoring

Participants are monitored using at-home devices and complete questionnaires on days 2, 7, 14, and 30 after discharge

4 weeks

Remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health Education
• Medical Device Usage and Evaluation

Trial Overview The study tests if an at-home monitoring program using devices (thermometer, pulse oximeter, scale, Vivofit watch) and apps to track health data can improve post-surgery care in cancer patients by catching complications early.

How Is the Trial Designed?

Group I: Arm I (telemonitoring) Experimental Treatment 4 Interventions

Patients wear a Vivofit 4 daily for 30 days after hospital discharge for steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients assessments are monitored by the surgical team in real-time to identify outcome trends, including onset, worsening/improving measures, and sporadic versus consistent measures.

Group II: Arm II (enhanced usual care) Active Control 4 Interventions

Patients wear a Vivofit 4 for daily steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality of life using the Aetonixx app up to 7 days before surgery, before being discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard procedures for reporting problems.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 21 complex general and urologic oncology surgery patients showed that remote telemonitoring of health data and patient-reported outcomes is feasible, with high adherence rates of 95% before surgery and 91% at discharge.

Despite high adherence, patients experienced significant declines in mobility and daily activities shortly after discharge, indicating the need for ongoing support and monitoring in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of perioperative remote monitoring of patient-generated health data in complex surgical oncology. Melstrom, LG., Zhou, X., Kaiser, A., et al.[2023]

In a study of 108 outpatients with advanced cancers, standardized pain education combined with telemonitoring significantly reduced pain intensity, anxiety, and depression after one week, indicating its effectiveness in managing symptoms.

The telemonitoring group showed a greater improvement in pain levels, particularly for patients experiencing higher pain scores, suggesting that this approach enhances pain management in outpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of standardized education and telemonitoring for pain in outpatients with advanced solid tumors. Kim, HS., Shin, SJ., Kim, SC., et al.[2021]

Using consumer-based activity monitors (CAMs) during the perioperative period for patients undergoing major oncologic surgery is feasible, with 86% of participants providing analyzable data.

Despite high compliance before surgery, the significant drop in activity levels (77% reduction in daily steps) post-surgery suggests that CAMs could help identify patients at risk for postoperative complications, although traditional measures of functional status may not effectively capture these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of low-cost accelerometers in measuring functional recovery after major oncologic surgery. Barkley, R., Khalil, M., Shen, P., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12394556/

Comparative effectiveness of remote perioperative ... In cancer surgery, the current evidence suggests that remote telemonitoring programs are feasible and acceptable, with preliminary evidence ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04030624

Remote Electronic Patient Monitoring in Gastrointestinal ... The Remote Patient Monitoring system uses algorithms that can indicate when patient vitals and patient-reported outcomes have changed. Automatic patient surveys ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X24005973

Thematic analysis of patient perspectives in a randomized ... This study assessed the patient-reported experience during perioperative telemonitoring for gastrointestinal (GI) oncologic surgery.

4. cancernetwork.com cancernetwork.com/view/perioperative-telemonitoring-yields-encouraging-results-in-gi-cancers

Perioperative Telemonitoring Yields “Encouraging” Results ... Patient-reported symptoms following surgery appear to improve with the use of perioperative telemonitoring, says Kelly M. Mahuron, MD.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833891

Remote Symptom Monitoring With Electronic Patient ... This nonrandomized controlled trial found that RSM implementation was associated with reduced risk of hospitalizations for patients with cancer.

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

Comparative effectiveness of remote perioperative ... A recent systematic review of ePROs in cancer care confirmed that ePRO monitoring has positive clinical impact on outcomes (symptoms, QOL, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10694107/

Randomized Controlled Trial of Perioperative ... Predicting post-discharge cancer surgery complications via telemonitoring of patient-reported outcomes and patient-generated health data. J ...

8. news.med.miami.edu news.med.miami.edu/remote-monitoring-improves-recovery-from-cancer-surgery/

Remote Monitoring Improves Recovery from Cancer Surgery A new study co-authored by Dr. Tracy Crane shows that remote perioperative monitoring improves recovery for cancer surgery patients.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2369199921000562

Remote Monitoring of the Performance Status and Burden ... This study demonstrates the feasibility of using inexpensive, consumer-based activity trackers for the remote monitoring of performance status in the ...