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

134 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to see whether an at-home monitoring program that collects health, symptoms, and quality of life data in real-time can be included as part of the care of surgery patients in order to provide better recovery. Patient-generated health data (weight, temperature, oxygen level, heart rate, blood pressure, daily steps, symptoms, quality of life) using at-home monitoring devices (thermometer, a pulse oximeter, a digital scale and a Vivofit 4 watch) and smart device applications are used more and more to measure value and quality in cancer care. However, measuring patient-generated health data is not currently part of standard care following cancer surgery. An at-home monitoring program may improve the care of patients after hospital discharge from surgery and may help reduce complications by identifying issues early.

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 data supports the effectiveness of this treatment for gastrointestinal cancer?

Research suggests that telemonitoring, which involves remotely tracking patients' health data, can improve outcomes and self-management for patients undergoing major abdominal surgery. Additionally, combining telemonitoring with educational tools has been shown to help improve pain and quality of life in patients with advanced cancers. ^{1 2 3 4 5}

Is perioperative telemonitoring safe for humans?

The studies suggest that perioperative telemonitoring, which involves remotely tracking health data before and after surgery, is feasible and has been used in various types of surgeries, including major abdominal and complex cancer surgeries, without specific safety concerns reported. ^{1 2 3 5 6}

How does perioperative telemonitoring differ from other treatments for gastrointestinal cancer?

Perioperative telemonitoring is unique because it involves remotely tracking a patient's health data and self-reported outcomes before and after surgery, which can improve recovery and self-management. Unlike traditional treatments that focus solely on the surgical procedure, this approach uses technology to personalize and optimize the patient's physical and mental condition throughout the surgical process. ^{1 2 3 7 8}

Research Team

Laleh Melstrom

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility and patient's experiences of perioperative telemonitoring in major abdominal surgery: an observational pilot study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of perioperative remote monitoring of patient-generated health data in complex surgical oncology. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of current perioperative telemonitoring on postoperative outcome in patients undergoing major abdominal surgery: A systematic review of controlled trials. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Wireless Monitoring Program of Patient-Centered Outcomes and Recovery Before and After Major Abdominal Cancer Surgery. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of standardized education and telemonitoring for pain in outpatients with advanced solid tumors. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Electronic Patient Reported Outcomes in Paediatric Oncology - Applying Mobile and Near Field Communication Technology. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility of low-cost accelerometers in measuring functional recovery after major oncologic surgery. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Determining the Reliable Measurement Period for Preoperative Baseline Values With Telemonitoring Before Major Abdominal Surgery: Pilot Cohort Study. [2022]