Recruiting

Remote Symptom Collection

Sponsor:

Medstar Health Research Institute

Code:

NCT06190730

Conditions

Gastrointestinal Cancer

Gastrointestinal Tumor

Gastrointestinal Tumor Surgery

Gastrointestinal Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Voice-Assisted Remote Symptom Monitoring System (VARSMS)

Study Details

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.

Conditions

Gastrointestinal Cancer

Gastrointestinal Tumor

Gastrointestinal Tumor Surgery

Gastrointestinal Surgery

Study ID

NCT06190730

Start date

Jul 23, 2024

Status verified date

Jan, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

281 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control

Besides the consent process, subjects in this arm will have no other research-specific activities until after 40 days after the surgery for an exit interview.

experimental: Voice-Assisted Remote Symptom Monitoring System (VARSMS) group

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.

Interventions

Voice-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.

Primary outcome measure

  • Custom questionnaire based on NCI PRO CTCAE (National Cancer Institute- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) [ Time Frame: 40 days ]

Central Contacts and Locations

Central contacts

Nawar Shara, PhD

301-502-0339nawar.shara@medstar.net

Crisanto Macaraeg, MD

410-261-8218crisanto.l.macaraeg@medstar.net

Locations

MedStar Health

Recruiting

Baltimore, Maryland, United States, 21218

Creighton University

Recruiting

Omaha, Nebraska, United States, 68124

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Apr 3, 2025

Last verified

Jan, 2025

Keywords

  • speech system
  • large language model
  • ai

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2025-04-03.