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Perioperative Telemonitoring to Optimize Cancer Care and Outcomes

Primary Purpose

Malignant Digestive System Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Health Education
Medical Device Usage and Evaluation
Quality-of-Life Assessment
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Digestive System Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (telemonitoring)

Arm II (enhanced usual care)

Arm Description

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.

Outcomes

Primary Outcome Measures

Patient postoperative complications using the Comprehensive Complications Index (CCI)
0-100 scale, higher score means higher risk for complications.
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.
Intervention Acceptability as reported by participants
Acceptability will be assessed through qualitative data analysis of exit interviews using content analysis approach.

Secondary Outcome Measures

Participant reported symptom severity score as measured by the MD Anderson Symptom Inventory (MDASI)
0-10 scale, higher scores means worse outcome.
Participant reported quality of life as measured by the EQ-5D-5L.
0-5 scale and 0-100 scale; higher score means worse outcome.
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.

Full Information

First Posted
June 11, 2021
Last Updated
October 23, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT04986566
Brief Title
Perioperative Telemonitoring to Optimize Cancer Care and Outcomes
Official Title
Perioperative Telemonitoring to Optimize Cancer Care and Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
September 29, 2024 (Anticipated)
Study Completion Date
September 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI), National Institute of Nursing Research (NINR)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Digestive System Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (telemonitoring)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (enhanced usual care)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care
Intervention Description
Use standard reporting procedures
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Use Aetonixx app
Intervention Type
Other
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Wear Vivofit 4
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Intervention Description
Complete questionnaires
Primary Outcome Measure Information:
Title
Patient postoperative complications using the Comprehensive Complications Index (CCI)
Description
0-100 scale, higher score means higher risk for complications.
Time Frame
From discharge to day 30 post-discharge
Title
Rratio of all participants to those who completed >= 70% of the study
Description
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.
Time Frame
Up to day 30 post-discharge
Title
Intervention Acceptability as reported by participants
Description
Acceptability will be assessed through qualitative data analysis of exit interviews using content analysis approach.
Time Frame
Up to day 30 post-discharge
Secondary Outcome Measure Information:
Title
Participant reported symptom severity score as measured by the MD Anderson Symptom Inventory (MDASI)
Description
0-10 scale, higher scores means worse outcome.
Time Frame
Up to day 30 post-discharge
Title
Participant reported quality of life as measured by the EQ-5D-5L.
Description
0-5 scale and 0-100 scale; higher score means worse outcome.
Time Frame
Up to day 30 post-discharge
Title
Healthcare resource use (e.g., hospital readmission)
Description
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.
Time Frame
Up to day 30 post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laleh Melstrom
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laleh Melstrom
Phone
626-218-7100
Email
lmelstrom@coh.org
First Name & Middle Initial & Last Name & Degree
Laleh Melstrom

12. IPD Sharing Statement

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Perioperative Telemonitoring to Optimize Cancer Care and Outcomes

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