Gastrointestinal Cancer, Gastrointestinal Surgery, Gastrointestinal Tumor, Gastrointestinal Tumor Surgery
Conditions
Keywords
speech system, large language model, ai
Brief summary
There are vulnerabilities in post-discharge care transition for patients after undergoing resection of malignant gastrointestinal tumors. This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges.
Detailed description
Randomized controlled trial comparing post-op patients randomized to using the VARSMS vs control.
Interventions
OTHERVoice-Assisted Remote Symptom Monitoring System (VARSMS)
Utilizing an Alexa Skill activated via an Amazon Echo Dot device, this system will administer two patient-reported outcomes measures to subjects. This will not be used as basis for diagnosis, nor for any clinical intervention.
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The Voice-Assisted Remote Symptom Monitoring System (VARSMS) will be installed on Amazon Echo Dot
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years old. Ages of subjects \>89 will simply be reported as \>90. 2. Scheduled for a GI surgery for management of a tumor in a participating hospital. 3. Fluent in oral and written English. 4. Has consistent and continued full access to an operational Wi-Fi for the duration of the study.
Exclusion criteria
1. Unable to provide informed consent. 2. Not willing to commit to regular participation in the study to include daily use (40 days) of the study application. 3. Life expectancy of less than 60 days. 4. In the opinion of the investigator, participation in this study is contraindicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Custom questionnaire based on NCI PRO CTCAE (National Cancer Institute- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) | 40 days | Daily symptom-based self-reported assessment on dyspnea, fever, melena, pain, wound healing, activities of daily living, sensorium, gastrointestinal motility, dysphagia, pitting edema, mood, and an option to mention symptoms not asked of. This is monitored by the research team, and any concerning finding, at the discretion of the site's physician, will be relayed to the subject's treating physician. Treating physician has final decision on whether to address referral by adjustment of management. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SASSI (Subjective Assessment of Speech System Interfaces) | 40 days | After interacting with the speech system for 40 days from the day after discharge, this questionnaire assesses the patient on their experience, having them rate the system based on system response accuracy, likeability, cognitive demand, annoyance, habitability, and speed. |
Countries
United States
Contacts
Primary ContactNawar Shara, PhD
Backup ContactCrisanto Macaraeg, MD
Outcome results
None listed