Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Behaviors and Mental Disorders

Rare Diseases

Emergencies

Dehydration

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Mouth Neoplasms

Water-Electrolyte Imbalance

Metabolic Diseases

Quality of Life

Oral Cancer

Hypopharyngeal Cancer

Surveys administered in person or by telephone interview and are audio-recorded.

Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer).

Surveys administered in person or by telephone interview and are audio-recorded.

Quality of life survey completed at baseline, 7 days after radiation therapy (RT) and at 6 - 8 weeks after RT.

Quality of Life Survey

Confidence in health management survey; completed at baseline and 6 - 8 weeks after RT.

Health Management Surveys

Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer)

Monitoring Devices

Behavioral: Symptoms survey 1; completed at weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT.

Behaviorial: Symptoms survey 2; completed at baseline, weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT.

Symptoms Surveys

Device usability survey; completed at weeks 1, 3, 5, and 7 days after RT.

Device Usability Survey

Susan K. Peterson, PHD, MPH

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.

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.

Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients

Primary outcome is proportion of patients who experience ER visits and/or hospitalizations related to dehydration (ERV) combined with ER visits resulting in hospitalization through the 6-7 weeks of RT. Primary analysis is comparison of proportion of patients in CYCORE group who have an ERV or ERHV and proportion of patients in the standard care group who have an ERV or ERHV. Analysis consists of a binomial test of two proportions using a continuity-corrected chi-square test. Analyses will follow the intention-to-treat principle, that is a patient in either arm who drops out is assumed to have an ERV and/or ERHV. For comparison purposes, data will be analyzed only using patients who have completed the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients	NCT02253238	Head and Neck C...	Quality of Life... Health Manageme... Monitoring Devi... Symptoms Survey... Device Usabilit...	18 Years -	M.D. Anderson Cancer Center
Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients	NCT02253238	Head and Neck C...	Quality of Life... Health Manageme... Monitoring Devi... Symptoms Survey... Device Usabilit...	18 Years -	M.D. Anderson Cancer Center
Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients	NCT02253238	Head and Neck C...	Quality of Life... Health Manageme... Monitoring Devi... Symptoms Survey... Device Usabilit...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for emergency room visits with hospitalization