Menu
Recruiting NCT06190730

REmote Symptom COllection to improVE postopeRative Care

No phase Interventional Gastrointestinal Cancer Gastrointestinal Tumor Gastrointestinal Tumor Surgery Gastrointestinal Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Voice-Assisted Remote Symptom Monitoring System (VARSMS).
Who it may be relevant to
Registry conditions: Gastrointestinal Cancer, Gastrointestinal Tumor, Gastrointestinal Tumor Surgery, Gastrointestinal Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other 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 measures

  • 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]
Secondary outcome measures (1)
  • SASSI (Subjective Assessment of Speech System Interfaces) [Time frame: 40 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • MedStar Health — Baltimore
  • Creighton University — Omaha

Identifiers

NCT: NCT06190730 · STUDY00007172

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗