Clinical trial NCT04030624: Remote Electronic Patient Monitoring in Gastrointestinal Cancer
Official title: Remote Electronic Patient Monitoring in Gastrointestinal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: The Feasibility of Remote Electronic Patient Monitoring Intervention
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period
timeFrame: 4 weeks
measure: Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period
timeFrame: 4 weeks
measure: Number of concerning issues identified per patient during study period
timeFrame: 4 weeks
measure: Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period
timeFrame: 4 weeks
measure: Number of intervention-triggered emails generated to the primary oncology team during study period
timeFrame: 4 weeks
measure: 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
timeFrame: 4 weeks
measure: Acceptability of Remote Electronic Patient Monitoring Intervention
timeFrame: 4 weeks
measure: Patient-Reported Quality of Life
timeFrame: 2 weeks and 4 weeks
measure: Patient-Reported Symptoms
timeFrame: 2 weeks and 4 weeks
measure: Patient-Reported Depression and Anxiety Symptoms
timeFrame: 2 weeks and 4 weeks
measure: Health Care Utilization
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Greer, MD
role: PRINCIPAL_INVESTIGATOR
References: