Perioperative Telemonitoring to Optimize Cancer Care and Outcomes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Digestive System Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Best Practice; Behavioral: Health Education; Other: Medical Device Usage and Evaluation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 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: Quality-of-Life Assessment; Complete questionnaires; Other: Best Practice; Use standard reporting procedures; Other Names: standard of care; Behavioral: Health Education; Use Aetonixx app; Other: Medical Device Usage and Evaluation; Wear Vivofit 4
Active Comparator: 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.	Other: Quality-of-Life Assessment; Complete questionnaires; Other: Best Practice; Use standard reporting procedures; Other Names: standard of care; Behavioral: Health Education; Use Aetonixx app; Other: Medical Device Usage and Evaluation; Wear Vivofit 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Postoperative Complications Using the Comprehensive Complications Index (CCI)	Postoperative complications occurring within 30 days post-discharge after cancer surgery were measured using the Comprehensive Complications index (CCI), a validated tool that aggregates the Clavien grades of postoperative complications on a continuous scale ranging from 0 (no complication) to 100 (death).	Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).
Number of Participants Who Completed >= 70% of the Study	Study completion was assessed based on the percentage of patients who completed at least 70% of the following during the study period: (a) daily step counts, (b) quality of life measures, and (c) patient-generated health data. These measures were assessed from baseline through 30 days post-discharge after cancer surgery.	Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).
Number of Participants Who Reported Intervention Acceptability	Acceptability of telemonitoring was assessed using a patient satisfaction tool administered within 30 days post-discharge after cancer surgery. The tool evaluated ease of use, time burden of participation, and access to technology.	Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI)	The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 scale, with 0 being "not present" and 10 being "as bad as you can imagine." Scores from baseline to 30 days post-discharge were calculated. A linear mixed effects model (adjusted for baseline scores) was used to assess differences in symptom severity between both arms over time.	Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge.
Participant Reported Quality of Life as Measured by the EQ-5D-5L.	The EQ-5D-5L descriptive system of 5 health dimensions includes 5 response categories of no problem, slight problems, moderate problems, severe problems, and extreme problems. The 5 responses give a health state or profile represented by a 5-digit number (for example, 12231) corresponding to response categories reported by patients. Health states are scored to give the EQ-5D-5L index using a scoring algorithm from a value set derived from valuation tasks typically undertaken with general population samples. Index scores range from -0.59 to 1 where 1 is the best possible health state. Scores from baseline to 30 days post-discharge were calculated. A linear mixed effects model (adjusted for baseline scores) was used to assess differences in QoL scores between both arms over time.	Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge.
Number of Participants Utilizing Healthcare Resource Use (Hospital Readmission)	Differences in the number of patients readmitted to the hospital for an overnight stay within 30 days post-discharge were compared between the two study arms using the Chi-square test or Fisher's exact test.	Up to day 30 post-discharge

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI); National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Laleh Melstrom, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Estimated): February 5, 2027

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Practice Guidelines as Topic
• Other Study ID Numbers: 20717 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2021-03335 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R21NR019866 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No