REmote Symptom COllection to improVE postopeRative Care

Not Applicable

Recruiting

• Conditions: Gastrointestinal Cancer; Gastrointestinal Tumor; Gastrointestinal Tumor Surgery; Gastrointestinal Surgery
• Interventions: Other: Voice-Assisted Remote Symptom Monitoring System (VARSMS)

• Registration Number: NCT06190730
• Lead Sponsor: Medstar Health Research Institute

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.

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2024-01-05
• Study Start: 2024-07-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 281

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Voice-Assisted Remote Symptom Monitoring System (VARSMS) group	Voice-Assisted Remote Symptom Monitoring System (VARSMS)	Subjects in this group will be issued the device, to be activated 1 day after discharge. The device will administer a set of questions daily.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

MedStar Health; 🇺🇸 Baltimore, Maryland, United States

Creighton University; 🇺🇸 Omaha, Nebraska, United States