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

Recruiting in Palo Alto (17 mi)

Overseen by Susan K. Peterson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Susan K. Peterson

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with certain head and neck cancers, who are fluent in English and receiving or scheduled to receive radiation at MD Anderson Cancer Center. It's not for those who've had previous radiation for these cancers, have a performance status >2, only palliative treatment, disabilities affecting scale use, unilateral radiation treatment, cognitive difficulties or dysphagia unrelated to cancer.

Inclusion Criteria

I am currently undergoing or scheduled for radiation treatment for my cancer.

I have been diagnosed with a specific stage of cancer in the head or neck.

I am 18 years old or older.

Exclusion Criteria

I have a condition that makes it hard for me to stand on a scale.

I am receiving radiation treatment for symptom relief, not to cure my disease.

I spend most of my day in bed or seated and need help with personal care.

Treatment Details

Interventions

• Device Usability Survey (Behavioral Intervention)
• Health Management Surveys (Behavioral Intervention)
• Monitoring Devices (Other)
• Quality of Life Survey (Behavioral Intervention)
• Symptoms Surveys (Behavioral Intervention)

Trial Overview The study tests if using home devices that assess dehydration risk can reduce hospital visits for head and neck cancer patients. One group uses the CYCORE system to monitor hydration at home while also completing health surveys; the other just completes surveys without device monitoring.

Participant Groups

Group I: Standard of Care Group Experimental Treatment 3 Interventions

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

Group II: CYCORE Group + Standard of Care Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School