REmote Symptom COllection to improVE postopeRative Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 281
- Locations
- 4
- Primary Endpoint
- Custom questionnaire based on NCI PRO CTCAE (National Cancer Institute- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years old. Ages of subjects >89 will simply be reported as >
- •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.
Outcomes
Primary Outcomes
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
- SASSI (Subjective Assessment of Speech System Interfaces)(40 days)