REmote Symptom COllection to improVE postopeRative Care

Gastrointestinal Cancer Clinical Trial

— RECOVER  

Official title:

REmote Symptom COllection to improVE postopeRative Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06190730
• Other study ID #: STUDY00007172
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: January 2028

Study information

• Verified date: April 2024
• Source: Medstar Health Research Institute
• Contact: Nawar Shara, PhD
• Phone: 301-502-0339
• Email: nawar.shara[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 281
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 18 years old. Ages of subjects >89 will simply be reported as >90.

2. Scheduled for a resection of a malignant GI 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.

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Other:
• Voice-Assisted Remote Symptom Monitoring System (VARSMS)
Installed on Amazon Echo Dot, 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NCI PRO CTCAE	National Cancer Institute (NCI)'s Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®)	40 days
Primary	SASSI	Subjective Assessment of Speech System Interfaces (SASSI)	40 days