Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02253238 |
| Other study ID # |
2013-0535 |
| Secondary ID |
1R01CA177914-01N |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 7, 2014 |
| Est. completion date |
April 30, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this research study is to learn if home-use of devices to identify dehydration
risk, when added to standard care, will help to lower hospitalizations and emergency room
visits (and related costs) in patients with head and neck cancer.
CYCORE is a software-based system that enables comprehensive collection, storage and analysis
of information related to cancer research and clinical care. In this study, those in the
CYCORE group use devices at home to measure their dehydration risk. This information is
monitored by their clinicians. Those in the standard care group complete health based
surveys, as do those in the CYCORE group.
Description:
Abstract:
While head and neck cancer (HNC) is highly curable, primary radiation treatment (RT) is
nonetheless challenging. Despite intensive, high-quality, multidisciplinary symptom
management of HNC patients during RT, up to 80% of these patients experience moderate to
severe levels of oral mucositis making it nearly impossible to drink sufficient fluids and
necessitating opioid care for pain. Our data show that 27 - 32% of HNC patients are admitted
to inpatient or emergency room (ER) units during RT. Those admissions related to dehydration
(and the accompanying costs) are largely preventable, provided at-risk patients can be
identified early for intravenous fluid rehydration. Currently, given standard of care for HNC
patients undergoing RT, clinicians assess patients only once per week during standard clinic
visits. However, the physiological changes underlying the onset of dehydration can develop
rapidly, often between clinic visits. In the proposed project, we focus on this missed
opportunity for prevention by testing the efficacy of a novel method for home-based
dehydration assessment and early intervention to reduce dehydration risk.
This project assesses the efficacy of a coordinated dehydration prevention program using a
system (CYCORE) that links home-based monitoring sensors--that collect biometric and
self-reported symptom data--to a cyber-infrastructure (CI) and sends these data daily to the
patient's healthcare team, who in turn monitor the patients for early signs of dehydration
and provide earlier clinical intervention, when needed. The project is based on our
successful pilot study that evaluated the feasibility of CYCORE use in HNC patients and with
their radiology healthcare team. The patients reported high acceptability of the system,
while clinicians perceived the data as valuable and useful in providing additional
information regarding patient's at-home dehydration status. We will randomize a total of 192
HNC patients receiving RT at MD Anderson Cancer Center (MDACC) to either standard care or
CYCORE + standard care (CYCORE). We hypothesize that patients randomized to CYCORE will
experience fewer hospitalizations and ER admissions (and fewer associated costs) due to
dehydration compared with patients in the standard care arm.
To the best of our knowledge, the application of a system such as CYCORE has not been
explored in the HNC population. Objective, home-based monitoring may be an optimal method of
capturing data critical to early evaluation of dehydration risk; other methods, such as
patient self-report, are limited by the patient's ability to accurately recall symptoms.
MDACC is an ideal environment for conducting the proposed study; more HNC patients are
treated with RT at MDACC compared with any other center in Texas, and it is possible to track
outcomes and cost-related data, given the HNC patients receive all of their RT-related care,
including related hospitalization and ER admissions, at one center. If our efficacy study
proves successful, this dehydration prevention model can potentially be applied to other
health conditions and in other settings.
