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NCT Number: NCT06190730

REmote Symptom COllection to improVE postopeRative Care

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.

Recruiting

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Surgery Gastrointestinal Tumor Gastrointestinal Tumor Surgery Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Health, Baltimore, Maryland, United States

Loading trial locations.

About this study

Randomized controlled trial comparing post-op patients randomized to using the VARSMS vs control.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old. Ages of subjects >89 will simply be reported as >90.
  • Scheduled for a GI surgery for management of a tumor in a participating hospital.
  • Fluent in oral and written English.
  • Has consistent and continued full access to an operational Wi-Fi for the duration of the study.

Exclusion criteria

  • Unable to provide informed consent.
  • Not willing to commit to regular participation in the study to include daily use (40 days) of the study application.
  • Life expectancy of less than 60 days.
  • In the opinion of the investigator, participation in this study is contraindicated.

Treatment and study plan

Voice-Assisted Remote Symptom Monitoring System (VARSMS)

Other

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.

Other names: Voice-Assisted Remote Symptom Monitoring System (VARSMS)- customization phase

Primary outcomes

  1. 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

    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 outcomes

  1. SASSI (Subjective Assessment of Speech System Interfaces)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Crisanto Macaraeg, MD

CONTACT

[email protected]

410-261-8218

Nawar Shara, PhD

CONTACT

[email protected]

301-502-0339

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Acronym: RECOVER

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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