Remote Electronic Patient Monitoring in Gastrointestinal Cancer
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|ClinicalTrials.gov Identifier: NCT04030624|
Recruitment Status : Withdrawn (Funding discontinued due to changes in corporate structures)
First Posted : July 24, 2019
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Cancer||Device: Remote Electronic Patient Monitoring||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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|
Experimental: Remote Electronic Patient Monitoring
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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030624
|Principal Investigator:||Joseph Greer, MD||Massachusetts General Hospital|