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NCT02253238 · ClinicalTrials.gov registry record · NA
Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients
A NA study of Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- NA
- Development phase
- 427
- Enrollment target
- 1
- Study location
NCT02253238: Active NA study of Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center.
NCT02253238 is a NA study of Head and Neck Cancer that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 427 participants, above the 259-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (65% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02253238, a NA study of Head and Neck Cancer, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 427 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL Quality of Life Survey
- BEHAVIORAL Health Management Surveys
- OTHER Monitoring Devices
- BEHAVIORAL Symptoms Surveys
- BEHAVIORAL Device Usability Survey
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 427 participants |
| Start Date | 2014-01-07 |
| Est. Completion | 2027-04-30 |
| Phase | NA |
What the registry record for NCT02253238 still lists
NCT02253238 is an interventional study that assigns participants to a tested intervention. The registered 427 participants enrollment target is mid-sized for trials with a published cap, above the 259-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (65% higher).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 5 interventions - of which Quality of Life Survey is the first listed.
NCT02253238 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02253238 about?
NCT02253238 is a clinical study titled "Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients". 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 compr...
What is the current status of trial NCT02253238?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 427 participants. The study started on 2014-01-07. Estimated completion is 2027-04-30.
What conditions does trial NCT02253238 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT02253238?
The interventions under investigation include: Quality of Life Survey (BEHAVIORAL), Health Management Surveys (BEHAVIORAL), Monitoring Devices (OTHER), Symptoms Surveys (BEHAVIORAL), Device Usability Survey (BEHAVIORAL).
Who is sponsoring clinical trial NCT02253238?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02253238 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02253238's enrollment target sits among peer trials
427 25th of 250 higher than 226 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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