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

NCT02253238 | Active Not Recruiting

• 3 other identifiers: 2013-05351R01CA177914-01NCI-2015-00946
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 - 15 weeks

Study Arms (2)

Standard of Care Group

OTHER

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

Behavioral: Quality of Life Survey; Behavioral: Health Management Surveys; Behavioral: Symptoms Surveys

CYCORE Group + Standard of Care

EXPERIMENTAL

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.

Behavioral: Quality of Life Survey; Behavioral: Health Management Surveys; Other: Monitoring Devices; Behavioral: Symptoms Surveys; Behavioral: Device Usability Survey

Interventions

Quality of Life Survey BEHAVIORAL

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

Also known as: Survey

CYCORE Group + Standard of Care; Standard of Care Group

Health Management Surveys BEHAVIORAL

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

Also known as: Questionnaires

CYCORE Group + Standard of Care; Standard of Care Group

Monitoring Devices OTHER

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

CYCORE Group + Standard of Care

Symptoms Surveys BEHAVIORAL

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.

CYCORE Group + Standard of Care; Standard of Care Group

Device Usability Survey BEHAVIORAL

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

Also known as: Questionnaire

CYCORE Group + Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms; Dehydration; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Nasopharyngeal Neoplasms; Salivary Gland Neoplasms; Mouth Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Diseases; Mouth Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Susan K. Peterson, PHD, MPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 1, 2014
• Study Start: January 7, 2014
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)