Trial Title:
Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients
NCT ID:
NCT02253238
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Dehydration
Conditions: Keywords:
Head and Neck Cancer
Dehydration
Sensor-based home monitoring
Radiation therapy
RT
XRT
Oropharyngeal cancer
Hypopharyngeal cancer
Nasopharyngeal cancer
Salivary gland cancer
Oral cavity cancer
Questionnaires
Surveys
Quality of life
QOL
Phone calls
Self-monitoring devices
CYberinfrastructure for COmparative effectiveness REsearch
CYCORE
Emergency room visits
ER
Emergency room visits with hospitalization
ERHV
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Quality of Life Survey
Description:
Quality of life survey completed at baseline, 7 days after radiation therapy (RT) and at
6 - 8 weeks after RT.
Arm group label:
CYCORE Group + Standard of Care
Arm group label:
Standard of Care Group
Other name:
Survey
Intervention type:
Behavioral
Intervention name:
Health Management Surveys
Description:
Confidence in health management survey; completed at baseline and 6 - 8 weeks after RT.
Arm group label:
CYCORE Group + Standard of Care
Arm group label:
Standard of Care Group
Other name:
Questionnaires
Intervention type:
Other
Intervention name:
Monitoring Devices
Description:
Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet,
palm-sized plug-in computer)
Arm group label:
CYCORE Group + Standard of Care
Intervention type:
Behavioral
Intervention name:
Symptoms Surveys
Description:
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.
Arm group label:
CYCORE Group + Standard of Care
Arm group label:
Standard of Care Group
Intervention type:
Behavioral
Intervention name:
Device Usability Survey
Description:
Device usability survey; completed at weeks 1, 3, 5, and 7 days after RT.
Arm group label:
CYCORE Group + Standard of Care
Other name:
Questionnaire
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosis of any of the following cancers: stage 1-4b (includes 4a) oropharyngeal,
hypopharyngeal, nasopharyngeal, salivary gland or oral cavity; stage 3-4b (includes
4a) laryngeal; any unknown primary head and neck cancer with cervical metastasis
that will be addressed with treatment to bilateral necks and mucosa; any thyroid
cancer that will be addressed with treatment to the bilateral necks; or other head
and neck cancers medically approved by one of our Radiation Oncology collaborating
MDs
2. Currently receiving (or scheduled to receive) radiation treatment for a cancer
listed in the inclusion criteria
3. Age 18 years or older
4. Fluent in English
5. Radiation treatment for this cancer was completed (or will be completed) at MD
Anderson Cancer Center (Post-RT study only)
6. Receiving radiation treatment for this cancer at any site within the MDACC Cancer
Network (Cancer Network study only)
Exclusion Criteria:
1. Overt cognitive difficulty demonstrated by not being clearly oriented to person or
place or time
2. Zubrod Performance Status >2, or self-reports either not being up and about more
than 50% of waking hours or unable to provide self-care
3. History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g.
dysphagia due to underlying neurogenic disorder)
4. Orthopedic, neurologic, or musculoskeletal disability that would interfere with the
functional task of standing on a weight scale
5. Scheduled to receive or receiving unilateral radiation treatment for this cancer
6. Received previous radiation treatment for head and neck cancer
7. Consented to enroll in a trial with a toxicity endpoint
8. Undergoing only palliative (not curative) radiation treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Start date:
January 7, 2014
Completion date:
April 30, 2025
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02253238
http://www.mdanderson.org
