Remote Electronic Patient Monitoring in Gastrointestinal Cancer

Gastrointestinal Cancer Clinical Trial

Official title:

Remote Electronic Patient Monitoring in Gastrointestinal Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04030624
• Other study ID #: 19-329
• Status: Withdrawn
• Phase: N/A
• Start date: September 2020
• Est. completion date: September 9, 2020

Study information

• Verified date: November 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Feasibility of Remote Electronic Patient Monitoring Intervention	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.	4 weeks
Secondary	Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period		4 weeks
Secondary	Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period		4 weeks
Secondary	Number of concerning issues identified per patient during study period		4 weeks
Secondary	Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period		4 weeks
Secondary	Number of intervention-triggered emails generated to the primary oncology team during study period		4 weeks
Secondary	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		4 weeks
Secondary	Acceptability of Remote Electronic Patient Monitoring Intervention	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.	4 weeks
Secondary	Patient-Reported Quality of Life	Change in patient-reported quality of life from baseline to 2 and 4 weeks per the Functional Assessment of Cancer Therapy-General	2 weeks and 4 weeks
Secondary	Patient-Reported Symptoms	Change in patient-reported symptoms from baseline to 2 and 4 weeks per the Edmonton Symptom Assessment System-revised	2 weeks and 4 weeks
Secondary	Patient-Reported Depression and Anxiety Symptoms	Change in patient-reported depression and anxiety symptoms from baseline to 2 and 4 weeks per the Patient Health Questionnaire-4	2 weeks and 4 weeks
Secondary	Health Care Utilization	Number of urgent clinic visits, emergency department visits, and hospital admissions during study period	4 weeks