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

NCT02253238 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 427

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Quality of Life Survey

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

BEHAVIORAL

Health Management Surveys

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

OTHER

Monitoring Devices

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

BEHAVIORAL

Symptoms Surveys

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.

BEHAVIORAL

Device Usability Survey

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Susan K. Peterson, PHD, MPH · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-07
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02253238 on ClinicalTrials.gov