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

Primary Purpose

Head and Neck Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality of Life Survey
Health Management Surveys
Monitoring Devices
Symptoms Surveys
Device Usability Survey
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard of Care Group

CYCORE Group + Standard of Care

Arm Description

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.

Outcomes

Primary Outcome Measures

Comparison Between the Two Groups of the Number of Hospitalizations and ER Visits Due to Dehydration
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.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2014
Last Updated
June 7, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02253238
Brief Title
Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients
Official Title
Sensor-Assisted Prevention of Dehydration in Head and Neck Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 7, 2014 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
427 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Group
Arm Type
Other
Arm Description
Surveys administered in person or by telephone interview and are audio-recorded.
Arm Title
CYCORE Group + Standard of Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Quality of Life Survey
Other Intervention Name(s)
Survey
Intervention Description
Quality of life survey completed at baseline, 7 days after radiation therapy (RT) and at 6 - 8 weeks after RT.
Intervention Type
Behavioral
Intervention Name(s)
Health Management Surveys
Other Intervention Name(s)
Questionnaires
Intervention Description
Confidence in health management survey; completed at baseline and 6 - 8 weeks after RT.
Intervention Type
Other
Intervention Name(s)
Monitoring Devices
Intervention Description
Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer)
Intervention Type
Behavioral
Intervention Name(s)
Symptoms Surveys
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Device Usability Survey
Other Intervention Name(s)
Questionnaire
Intervention Description
Device usability survey; completed at weeks 1, 3, 5, and 7 days after RT.
Primary Outcome Measure Information:
Title
Comparison Between the Two Groups of the Number of Hospitalizations and ER Visits Due to Dehydration
Description
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.
Time Frame
12 - 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Currently receiving (or scheduled to receive) radiation treatment for a cancer listed in the inclusion criteria Age 18 years or older Fluent in English Radiation treatment for this cancer was completed (or will be completed) at MD Anderson Cancer Center (Post-RT study only) Receiving radiation treatment for this cancer at any site within the MDACC Cancer Network (Cancer Network study only) Exclusion Criteria: Overt cognitive difficulty demonstrated by not being clearly oriented to person or place or time 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 History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder) Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale Scheduled to receive or receiving unilateral radiation treatment for this cancer Received previous radiation treatment for head and neck cancer Consented to enroll in a trial with a toxicity endpoint Undergoing only palliative (not curative) radiation treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan K. Peterson, PHD, MPH
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center

Learn more about this trial

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

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