Perioperative Telemonitoring to Optimize Cancer Care and Outcomes
Malignant Digestive System Neoplasm
About this trial
This is an interventional supportive care trial for Malignant Digestive System Neoplasm
Eligibility Criteria
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
Sites / Locations
- City of Hope Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I (telemonitoring)
Arm II (enhanced usual care)
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.
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.