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出境医 / 临床实验 / Remote Electronic Patient Monitoring in Gastrointestinal Cancer

Remote Electronic Patient Monitoring in Gastrointestinal Cancer

Study Description
Brief Summary:
The goal of this research study is to evaluate a program that involves remote electronic monitoring of vital signs and symptoms of patients with gastrointestinal cancer who were recently hospitalized at Massachusetts General Hospital or presented to the oncology clinic for an unplanned, urgent visit.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Device: Remote Electronic Patient Monitoring Not Applicable

Detailed Description:

Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and its treatment. Unfortunately, patients commonly require hospital admission or urgent clinic visits to help manage uncontrolled symptoms. For this study, the investigators seek to determine if a program that entails remote electronic monitoring may improve the overall care experience of patients with gastrointestinal cancer who have urgent care needs.

The investigators are asking the participants to take part in this research study because the participants are currently hospitalized at Massachusetts General Hospital or recently presented to the oncology clinic for an urgent visit, and are receiving treatment at the Cancer Center. The goal of this study is to test a program that involves remote electronic monitoring of vital signs and patient-reported health outcomes. This study is a pilot study, and the investigators are evaluating the feasibility of delivering the program, the acceptability and satisfaction with the program, changes in the quality of life and symptoms of patients who receive the program, as well as the frequency of urgent hospital visits while the patient is in the program.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Remote Electronic Patient Monitoring in Gastrointestinal Cancer
Estimated Study Start Date : September 2020
Actual Primary Completion Date : September 9, 2020
Actual Study Completion Date : September 9, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Remote Electronic Patient Monitoring
  • The Remote Electronic Patient Monitoring intervention will entail monitoring of vital sign data and patient reported assessments to address and manage any concerning issues identified.
  • The Remote Patient Monitoring system uses algorithms that can indicate when patient vitals and patient-reported outcomes have changed.
  • Automatic patient surveys are sent to the patient with results displayed on the clinician user interface (i.e., dashboard) on a computer located in the clinical area.
  • Qualitative interviews with patient participants and their oncology clinicians using a semi-structured interview guide will be conducted.
 Device: Remote Electronic Patient Monitoring
The Remote Patient Monitoring intervention is a remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Throughout the day, patient data from the remote monitoring system are presented on the clinician user interface (e.g., temperature, blood pressure, heart rate, respiration rate). Data are transmitted from sensors to the patient's smart phone.
Outcome Measures
Primary Outcome Measures :
  1. The Feasibility of Remote Electronic Patient Monitoring Intervention [ Time Frame: 4 weeks ]
    The intervention will be deemed feasible if at least 50% (95% confidence interval +/- 13%) of patients agree to participate in the study and sign informed consent, and if participants wear the Remote Electronic Patient Monitoring device ≥ 50% (95% confidence interval +/- 13%) of the time within the two weeks following the baseline time point.


Secondary Outcome Measures :
  1. Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period [ Time Frame: 4 weeks ]
  2. Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period [ Time Frame: 4 weeks ]
  3. Number of concerning issues identified per patient during study period [ Time Frame: 4 weeks ]
  4. Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period [ Time Frame: 4 weeks ]
  5. Number of intervention-triggered emails generated to the primary oncology team during study period [ Time Frame: 4 weeks ]
  6. Proportion of intervention-triggered events that are not clinically acted upon (i.e., no change in patient care based on an intervention trigger) during study period [ Time Frame: 4 weeks ]
  7. Acceptability of Remote Electronic Patient Monitoring Intervention [ Time Frame: 4 weeks ]
    Participant report of perceptions of the usefulness, effectiveness, and relevance of the intervention per acceptability ratings and qualitative interviews with patient participants and their clinicians.

  8. Patient-Reported Quality of Life [ Time Frame: 2 weeks and 4 weeks ]
    Change in patient-reported quality of life from baseline to 2 and 4 weeks per the Functional Assessment of Cancer Therapy-General

  9. Patient-Reported Symptoms [ Time Frame: 2 weeks and 4 weeks ]
    Change in patient-reported symptoms from baseline to 2 and 4 weeks per the Edmonton Symptom Assessment System-revised

  10. Patient-Reported Depression and Anxiety Symptoms [ Time Frame: 2 weeks and 4 weeks ]
    Change in patient-reported depression and anxiety symptoms from baseline to 2 and 4 weeks per the Patient Health Questionnaire-4

  11. Health Care Utilization [ Time Frame: 4 weeks ]
    Number of urgent clinic visits, emergency department visits, and hospital admissions during study period


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Diagnosed with gastrointestinal cancer
  • Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
  • Planning to receive outpatient care at the MGH Cancer Center
  • Ability to read and respond to questions in English

Exclusion Criteria:

  • Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
  • Enrolled in hospice
  • Planning to be discharged to any location other than their home
Contacts and Locations

Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Joseph Greer, MD Massachusetts General Hospital
Tracking Information
First Submitted Date  ICMJE July 22, 2019
First Posted Date  ICMJE July 24, 2019
Last Update Posted Date November 13, 2020
Estimated Study Start Date  ICMJE September 2020
Actual Primary Completion Date September 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019) 		The Feasibility of Remote Electronic Patient Monitoring Intervention [ Time Frame: 4 weeks ]
The intervention will be deemed feasible if at least 50% (95% confidence interval +/- 13%) of patients agree to participate in the study and sign informed consent, and if participants wear the Remote Electronic Patient Monitoring device ≥ 50% (95% confidence interval +/- 13%) of the time within the two weeks following the baseline time point.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
  • Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period [ Time Frame: 4 weeks ]
  • Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period [ Time Frame: 4 weeks ]
  • Number of concerning issues identified per patient during study period [ Time Frame: 4 weeks ]
  • Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period [ Time Frame: 4 weeks ]
  • Number of intervention-triggered emails generated to the primary oncology team during study period [ Time Frame: 4 weeks ]
  • Proportion of intervention-triggered events that are not clinically acted upon (i.e., no change in patient care based on an intervention trigger) during study period [ Time Frame: 4 weeks ]
  • Acceptability of Remote Electronic Patient Monitoring Intervention [ Time Frame: 4 weeks ]
    Participant report of perceptions of the usefulness, effectiveness, and relevance of the intervention per acceptability ratings and qualitative interviews with patient participants and their clinicians.
  • Patient-Reported Quality of Life [ Time Frame: 2 weeks and 4 weeks ]
    Change in patient-reported quality of life from baseline to 2 and 4 weeks per the Functional Assessment of Cancer Therapy-General
  • Patient-Reported Symptoms [ Time Frame: 2 weeks and 4 weeks ]
    Change in patient-reported symptoms from baseline to 2 and 4 weeks per the Edmonton Symptom Assessment System-revised
  • Patient-Reported Depression and Anxiety Symptoms [ Time Frame: 2 weeks and 4 weeks ]
    Change in patient-reported depression and anxiety symptoms from baseline to 2 and 4 weeks per the Patient Health Questionnaire-4
  • Health Care Utilization [ Time Frame: 4 weeks ]
    Number of urgent clinic visits, emergency department visits, and hospital admissions during study period
Original Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device [ Time Frame: 4 weeks ]
  • Proportion of participants completing vital sign monitoring through the remote electronic monitoring device [ Time Frame: 4 weeks ]
  • Number of concerning issues identified per patient [ Time Frame: 4 weeks ]
  • Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls [ Time Frame: 4 weeks ]
  • Number of intervention-triggered emails generated to the primary oncology team [ Time Frame: 4 weeks ]
  • Proportion of intervention-triggered events that are not clinically acted upon (i.e., no change in patient care based on an intervention trigger) [ Time Frame: 4 weeks ]
  • Acceptability of Remote Electronic Patient Monitoring Intervention [ Time Frame: 4 weeks ]
    Perceptions of the usefulness, effectiveness, and relevance of the intervention will be assessed using acceptability ratings and qualitative interviews with patient participants and their clinicians.
  • Patient-Reported Quality of Life [ Time Frame: 2 weeks and 4 weeks ]
    Functional Assessment of Cancer Therapy-General questionnaire to assess physical, functional, emotional, and social functioning in past week
  • Patient-Reported Symptoms [ Time Frame: 2 weeks and 4 weeks ]
    Edmonton Symptom Assessment System-revised questionnaire to assess physical symptoms
  • Patient-Reported Depression and Anxiety Symptoms [ Time Frame: 2 weeks and 4 weeks ]
    Patient Health Questionnaire-4 questionnaire to assess depression and anxiety symptoms
  • Health Care Utilization [ Time Frame: 4 weeks ]
    Urgent clinic visits, emergency department visits, and hospital admissions
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Electronic Patient Monitoring in Gastrointestinal Cancer
Official Title  ICMJE Remote Electronic Patient Monitoring in Gastrointestinal Cancer
Brief Summary The goal of this research study is to evaluate a program that involves remote electronic monitoring of vital signs and symptoms of patients with gastrointestinal cancer who were recently hospitalized at Massachusetts General Hospital or presented to the oncology clinic for an unplanned, urgent visit.
Detailed Description

Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and its treatment. Unfortunately, patients commonly require hospital admission or urgent clinic visits to help manage uncontrolled symptoms. For this study, the investigators seek to determine if a program that entails remote electronic monitoring may improve the overall care experience of patients with gastrointestinal cancer who have urgent care needs.

The investigators are asking the participants to take part in this research study because the participants are currently hospitalized at Massachusetts General Hospital or recently presented to the oncology clinic for an urgent visit, and are receiving treatment at the Cancer Center. The goal of this study is to test a program that involves remote electronic monitoring of vital signs and patient-reported health outcomes. This study is a pilot study, and the investigators are evaluating the feasibility of delivering the program, the acceptability and satisfaction with the program, changes in the quality of life and symptoms of patients who receive the program, as well as the frequency of urgent hospital visits while the patient is in the program.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Gastrointestinal Cancer
Intervention  ICMJE Device: Remote Electronic Patient Monitoring
The Remote Patient Monitoring intervention is a remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Throughout the day, patient data from the remote monitoring system are presented on the clinician user interface (e.g., temperature, blood pressure, heart rate, respiration rate). Data are transmitted from sensors to the patient's smart phone.
Study Arms  ICMJE Experimental: Remote Electronic Patient Monitoring
  • The Remote Electronic Patient Monitoring intervention will entail monitoring of vital sign data and patient reported assessments to address and manage any concerning issues identified.
  • The Remote Patient Monitoring system uses algorithms that can indicate when patient vitals and patient-reported outcomes have changed.
  • Automatic patient surveys are sent to the patient with results displayed on the clinician user interface (i.e., dashboard) on a computer located in the clinical area.
  • Qualitative interviews with patient participants and their oncology clinicians using a semi-structured interview guide will be conducted.
Intervention: Device: Remote Electronic Patient Monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 10, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2019) 		75
Actual Study Completion Date  ICMJE September 9, 2020
Actual Primary Completion Date September 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 or older
  • Diagnosed with gastrointestinal cancer
  • Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
  • Planning to receive outpatient care at the MGH Cancer Center
  • Ability to read and respond to questions in English

Exclusion Criteria:

  • Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
  • Enrolled in hospice
  • Planning to be discharged to any location other than their home
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT04030624
Other Study ID Numbers  ICMJE 19-329
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
Responsible Party Joseph A. Greer, Ph.D., Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Greer, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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