Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04986566 |
Other study ID # |
20717 |
Secondary ID |
NCI-2021-0333520 |
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 19, 2021 |
Est. completion date |
December 31, 2024 |
Study information
Verified date |
June 2024 |
Source |
City of Hope Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study aims to see whether an at-home monitoring program that collects health, symptoms,
and quality of life data in real-time can be included as part of the care of surgery patients
in order to provide better recovery. Patient-generated health data (weight, temperature,
oxygen level, heart rate, blood pressure, daily steps, symptoms, quality of life) using
at-home monitoring devices (thermometer, a pulse oximeter, a digital scale and a Vivofit 4
watch) and smart device applications are used more and more to measure value and quality in
cancer care. However, measuring patient-generated health data is not currently part of
standard care following cancer surgery. An at-home monitoring program may improve the care of
patients after hospital discharge from surgery and may help reduce complications by
identifying issues early.
Description:
PRIMARY OBJECTIVE:
I. To conduct a pilot randomized trial of a remote, perioperative telemonitoring intervention
to improve patient-centered outcomes, surgical outcomes, and healthcare resource use in
English and Spanish-speaking patients scheduled to undergo major abdominal gastrointestinal
(GI) cancer surgery.
Ia. Assess the feasibility, retention, and acceptability of the remote perioperative
telemonitoring intervention as measured by the percentage of patients who a) agree to
participate; b) complete >= 70% of the telemonitoring; and c) report satisfaction with the
intervention through structured exit interviews.
Ib. Determine the preliminary efficacy of the remote perioperative telemonitoring
intervention on surgical outcomes, healthcare utilization, patient-reported outcomes (PROs),
and functional recovery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (TELEMONITORING): Patients wear a Vivofit 4 daily for 30 days after hospital discharge
for steps monitoring, and complete questionnaires over 5-7 minutes about symptoms and quality
of life using the Aetonixx application (app) up to 7 days before surgery, before being
discharged from the hospital after surgery, and on days 2, 7, 14, 30 after discharge.
Patients also complete pulse oximetry, temperature, blood pressure, heart rate, and weight
assessment using at-home monitoring devices before surgery, then on days 2, 7, 14, 30 after
discharge. Patients assessments are monitored by the surgical team in real-time to identify
outcome trends, including onset, worsening/improving measures, and sporadic versus consistent
measures.
ARM II (ENHANCED USUAL CARE): Patients wear a Vivofit 4 for daily steps monitoring, and
complete questionnaires over 5-7 minutes about symptoms and quality of life using the
Aetonixx app up to 7 days before surgery, before being discharged from the hospital after
surgery, and on days 2, 7, 14, 30 after discharge. Patients also complete pulse oximetry,
temperature, blood pressure, heart rate, and weight assessment using at-home monitoring
devices before surgery, then on days 2, 7, 14, 30 after discharge. Patients use standard
procedures for reporting problems.