Perioperative Telemonitoring to Optimize Cancer Care and Outcomes

Malignant Digestive System Neoplasm Clinical Trial

Official title:

Perioperative Telemonitoring to Optimize Cancer Care and Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04986566
• Other study ID #: 20717
• Secondary ID: NCI-2021-0333520
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 134
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Malignant Digestive System Neoplasm

Intervention

Other:
• Best Practice
Use standard reporting procedures

Behavioral:
• Health Education
Use Aetonixx app

Other:
• Medical Device Usage and Evaluation
Wear Vivofit 4
• Quality-of-Life Assessment
Complete questionnaires

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (3)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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