REmote Symptom COllection to improVE postopeRative Care

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Medstar Health Research Institute
Study ID
NCT06190730
Status
Recruiting
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Conditions

  • Gastrointestinal Cancer
  • Gastrointestinal Surgery
  • Gastrointestinal Tumor
  • Gastrointestinal Tumor Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 23, 2024
Status verified
Jan 2025
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
281 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
MedStar HealthBaltimoreMaryland21218-
Creighton UniversityOmahaNebraska68124-

Find similar trials in Baltimore, MD

By research site
MedStar Health· Baltimore, MDCreighton University· Omaha, NE

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