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

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive difficulty, Zubrod >2, Dysphagia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

427 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for preventing dehydration in head and neck cancer patients?

The use of telehealth and electronic patient-reported outcomes (ePROs) has shown promise in improving patient-provider communication and monitoring health-related quality of life in head and neck cancer patients. These technologies have been well accepted and regularly used by patients, suggesting they could be effective in supporting hydration management as part of comprehensive care. ^{1 2 3 4 5}

Is the use of wearable devices for monitoring dehydration in head and neck cancer patients safe?

The studies on wearable devices for monitoring head and neck cancer patients during radiotherapy focus on feasibility and data collection, but they do not report any safety concerns related to the use of these devices. ^{3 6 7 8 9}

How does the sensor-assisted treatment for preventing dehydration in head and neck cancer patients differ from other treatments?

This treatment is unique because it uses wearable technology, like smartwatches, to monitor patients' health data such as physical activity and heart rate during radiotherapy. This approach aims to detect and address dehydration and other side effects early, potentially reducing hospital visits and improving patient care outside the hospital. ^{3 5 6 7 10}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive primary radiation treatment (RT) for head and neck cancer

6-7 weeks

Weekly clinic visits

Monitoring

Home-based monitoring using CYCORE devices to assess dehydration risk and provide early intervention

6-7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Device Usability Survey
• Health Management Surveys
• Monitoring Devices
• Quality of Life Survey
• Symptoms Surveys

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The study involved 29 patients undergoing radiotherapy for head and neck cancer, but only 38% managed to provide step data for at least 80% of their treatment days, indicating challenges in continuous activity monitoring.

Higher daily step counts were associated with a significantly reduced risk of needing a feeding tube and hospitalization, suggesting that physical activity may play a protective role during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Activity Monitoring and Electronic Patient-Reported Outcomes Collection During Radiotherapy for Head and Neck Cancer: A Pilot Study. Ohri, N., Bar-Ad, V., Fernandez, C., et al.[2023]

The implementation of the electronic Patient-Reported Outcome Measure (PROM) 'OncoFunction' in head and neck cancer patients showed high feasibility, with 846 patients completing the PROM during 2,833 out of 3,610 visits (78.5%).

The latest version of 'OncoFunction' significantly reduced errors and time required for use, enhancing the efficiency of data collection and improving patient follow-up care by providing a comprehensive view of their health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obtaining Patient-Reported Outcomes Electronically With "OncoFunction" in Head and Neck Cancer Patients During Aftercare. Zebralla, V., Müller, J., Wald, T., et al.[2020]

The OncoWatch 1.0 feasibility study aims to assess whether patients with head and neck cancer can wear an Apple Watch continuously during radiotherapy, with a target of at least 12 hours per day.

This study will collect biometric data, such as heart rate and physical activity, to explore how these metrics change during treatment, potentially providing valuable insights for monitoring patient symptoms and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Biometric Sensor Data to Monitor Cancer Patients During Radiotherapy: Protocol for the OncoWatch Feasibility Study. Holländer-Mieritz, C., Vogelius, IR., Kristensen, CA., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Durable usage of patient-reported outcome measures in clinical practice to monitor health-related quality of life in head and neck cancer patients. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptance of a Telehealth Intervention to Promote Symptom Management during Treatment for Head and Neck Cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Remote Activity Monitoring and Electronic Patient-Reported Outcomes Collection During Radiotherapy for Head and Neck Cancer: A Pilot Study. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Obtaining Patient-Reported Outcomes Electronically With "OncoFunction" in Head and Neck Cancer Patients During Aftercare. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

The feasibility of telehealth in the monitoring of head and neck cancer patients: a systematic review on remote technology, user adherence, user satisfaction, and quality of life. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Using Wearables for Home Monitoring during Radiotherapy for Head and Neck Cancer-Results from the OncoWatch 1.0 Study. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Using Biometric Sensor Data to Monitor Cancer Patients During Radiotherapy: Protocol for the OncoWatch Feasibility Study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Identifying early dehydration risk with home-based sensors during radiation treatment: a feasibility study on patients with head and neck cancer. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Use of mobile device technology to continuously collect patient-reported symptoms during radiation therapy for head and neck cancer: A prospective feasibility study. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Pilot Study of a Wearable Activity Monitor During Head and Neck Radiotherapy to Predict Clinical Outcomes. [2023]