Perioperative Telemonitoring to Optimize Cancer Care and Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVE: I. To conduct a pilot randomized trial of a remote, perioperative telemonitoring intervention to improve patient-centered outcomes, surgical outcomes, and healthcare resource use in English and Spanish-speaking patients scheduled to undergo major abdominal gastrointestinal (GI) cancer surgery. Ia. Assess the feasibility, retention, and acceptability of the remote perioperative telemonitoring intervention as measured by the percentage of patients who a) agree to participate; b) complete >= 70% of the telemonitoring; and c) report satisfaction with the intervention through structured exit interviews. Ib. Determine the preliminary efficacy of the remote perioperative telemonitoring intervention on surgical outcomes, healthcare utilization, patient-reported outcomes (PROs), and functional recovery. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (TELEMONITORING): 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 application (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. ARM II (ENHANCED USUAL CARE): 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.

Official Title
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Perioperative Telemonitoring to Optimize Cancer Care and Outcomes

Conditions
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Malignant Digestive System Neoplasm

Intervention / Treatment
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* Other: Best Practice
* Behavioral: Health Education
* Other: Medical Device Usage and Evaluation
* Other: Quality-of-Life Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer patients scheduled to undergo major abdominal surgery for gastrointestinal (GI) malignancies. GI procedures include esophagectomy, gastrectomy, colectomy, abdominoperineal resection/low anterior resection, hepatectomy, pancreatectomy (distal or pancreaticoduodenectomy), and cytoreductive surgery for peritoneal carcinomatosis. We will include patients scheduled for an ostomy (colostomy or diverting ileostomy) Age 18 years or older Ability to read and understand English or Spanish We are targeting patients across all stages of disease Age criterion for this study is based on the National Institute of Health (NIH)'s age criteria, which defines an adult as individuals aged 18 years and over. There are no restrictions related to performance status or life expectancy All subjects must have the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (telemonitoring)<br>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. | Other: Best Practice<br>* Use standard reporting procedures<br>* Other names: standard of care;Behavioral: Health Education<br>* Use Aetonixx app<br>Other: Medical Device Usage and Evaluation<br>* Wear Vivofit 4<br>Other: Quality-of-Life Assessment<br>* Complete questionnaires<br>|
| Active Comparator: Arm II (enhanced usual care)<br>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. | Other: Best Practice<br>* Use standard reporting procedures<br>* Other names: standard of care;Behavioral: Health Education<br>* Use Aetonixx app<br>Other: Medical Device Usage and Evaluation<br>* Wear Vivofit 4<br>Other: Quality-of-Life Assessment<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient postoperative complications using the Comprehensive Complications Index (CCI) | 0-100 scale, higher score means higher risk for complications. | From discharge to day 30 post-discharge | 
| Rratio of all participants to those who completed >= 70% of the study | Will be evaluated based on data obtained throughout the study. Descriptive statistics will be assessed using means, standard deviations, and ranges for continuous variables, and frequencies and percentages for categorical variables. | Up to day 30 post-discharge | 
| Intervention Acceptability as reported by participants | Acceptability will be assessed through qualitative data analysis of exit interviews using content analysis approach. | Up to day 30 post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant reported symptom severity score as measured by the MD Anderson Symptom Inventory (MDASI) | 0-10 scale, higher scores means worse outcome. | Up to day 30 post-discharge | 
| Participant reported quality of life as measured by the EQ-5D-5L. | 0-5 scale and 0-100 scale; higher score means worse outcome. | Up to day 30 post-discharge | 
| Healthcare resource use (e.g., hospital readmission) | Will estimate the emergency room visits/readmission rates and provide confidence intervals for each arm. Further, a binomial test for comparing two proportions will be conducted to see if there is significant difference between the readmission rates of the two arms. For simplicity, Bonferroni correction will be used both in the proportions comparisons test and the confidence intervals construction. | Up to day 30 post-discharge |