Clinical Trials Directory

Trials / Completed

CompletedNCT04501913

Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes

Remote Perioperative Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes

Status
Completed
Phase
—
Study type
Observational
Enrollment
22 (actual)
Sponsor
City of Hope Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study examines at-home monitoring of patient-generated phsyiologic health data and patient-reported outcomes. Patient-generated health data using at-home monitoring devices and smart device applications are used more and more to measure value and quality in cancer care. This trial may show whether at-home monitoring programs can improve the care of patients after hospital discharge from surgery.

Detailed description

PRIMARY OBJECTIVES: I. To assess the feasibility and acceptability of remote perioperative monitoring in solid tumor cancer patients scheduled for gastrointestinal (GI), genitourinary (GU), gynecological (GYN) cancer surgery. II. To explore patterns, trajectory, and changes in physiologic health parameter outcomes (weight, temperature, oxygen saturation, heart rate, blood pressure, daily steps) and patient-reported outcomes (PROs) (symptoms, quality of life \[QOL\]) from pre-surgery to the post-discharge period. III. To explore the relationship between changes in physiologic health parameter outcomes/PROs and surgical outcomes (postoperative complications, readmissions). IV. To explore changes in physiologic health parameters and PROs by open surgery versus minimally invasive (laparoscopic or robotic) surgery. OUTLINE: Patients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge. After completion of study, patients are followed up for 2 months.

Conditions

Interventions

TypeNameDescription
PROCEDUREPatient MonitoringUndergo remote perioperative telemonitoring
OTHERQuestionnaire AdministrationComplete questionnaires

Timeline

Start date
2019-12-24
Primary completion
2025-10-17
Completion
2025-10-17
First posted
2020-08-06
Last updated
2025-12-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04501913. Inclusion in this directory is not an endorsement.