Perioperative Telemonitoring to Optimize Cancer Care and Outcomes

NCT04986566 | Active Not Recruiting Results DMC

• 4 other identifiers: 20717NCI-2021-03335P30CA033572R21NR019866
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Digestive System Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Participant Reported Symptom Severity Score as Measured by the MD Anderson Symptom Inventory (MDASI)

  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.

  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)

  Up to day 30 post-discharge

Study Arms (2)

Arm I (telemonitoring)

EXPERIMENTAL

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; Behavioral: Health Education; Other: Medical Device Usage and Evaluation; Other: Quality-of-Life Assessment

Arm II (enhanced usual care)

ACTIVE COMPARATOR

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; Behavioral: Health Education; Other: Medical Device Usage and Evaluation; Other: Quality-of-Life Assessment

Interventions

Best Practice OTHER

Use standard reporting procedures

Also known as: standard of care

Arm I (telemonitoring); Arm II (enhanced usual care)

Health Education BEHAVIORAL

Use Aetonixx app

Arm I (telemonitoring); Arm II (enhanced usual care)

Medical Device Usage and Evaluation OTHER

Wear Vivofit 4

Arm I (telemonitoring); Arm II (enhanced usual care)

Quality-of-Life Assessment OTHER

Complete questionnaires

Arm I (telemonitoring); Arm II (enhanced usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Results Point of Contact

• Title: Dr, Laleh Melstrom
• Organization: City of Hope Medical Center

lmelstrom@coh.org

626-359-8111

Study Officials

• Laleh Melstrom

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: August 3, 2021
• Study Start: October 19, 2021
• Primary Completion: August 31, 2023
• Study Completion (Estimated): February 5, 2027
• Last Updated: March 27, 2026
• Results First Posted: December 5, 2025

Record last verified: 2026-03

Locations

US (1)