Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04986566

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Malignant Digestive System Neoplasm Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Use standard reporting procedures

Other names: standard of care

Health Education

Behavioral

Use Aetonixx app

Medical Device Usage and Evaluation

Other

Wear Vivofit 4

Quality-of-Life Assessment

Other

Complete questionnaires

Primary outcomes

  1. Patient Postoperative Complications Using the Comprehensive Complications Index (CCI)

    Time frame: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).

    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).

  2. Number of Participants Who Completed >= 70% of the Study

    Time frame: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).

    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.

  3. Number of Participants Who Reported Intervention Acceptability

    Time frame: Outcomes are measured up to 30 days post-discharge after cancer surgery. Duration of hospitalization: Median, 5 days (Min: 0, Max: 18).

    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.

Secondary outcomes

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

    Time frame: Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge.

    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.

  2. Participant Reported Quality of Life as Measured by the EQ-5D-5L.

    Time frame: Outcomes are measured at baseline, 2 days, 7 days, 14 days, and 30 days post-discharge.

    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.

  3. Number of Participants Utilizing Healthcare Resource Use (Hospital Readmission)

    Time frame: Up to day 30 post-discharge

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2027
First posted
Aug 3, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.