Alio Smart Patch Monitoring for Cancer Patients

Overseen By Naji Mallat, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: No cellphone access, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

30 Participants Needed

Trial Summary

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 seems focused on monitoring vital signs and blood levels, so you may not need to stop your medications, but it's best to confirm with the trial coordinators.

What data supports the effectiveness of the Alio Smart Patch™ treatment for cancer patients?

Research shows that wearable devices and mobile apps can help monitor symptoms and improve communication between patients and healthcare providers, leading to better clinical outcomes for cancer patients. These technologies can detect early signs of cancer relapse and manage symptoms effectively, which suggests that the Alio Smart Patch™ could be beneficial in similar ways. ^{1 2 3 4 5}

How does the Alio Smart Patch Monitoring treatment differ from other treatments for cancer patients?

The Alio Smart Patch Monitoring treatment is unique because it uses a wearable patch that allows for long-term, continuous monitoring without the need for wires or electrodes, offering patients more mobility and comfort compared to traditional methods. ^{6 7 8 9 10}

What is the purpose of this trial?

Undergoing cancer treatment comes with various risks and side effects. This clinical trial aims to reduce those risks and side effects through continuous monitoring of vital signs and blood levels. The goal is to see if potential side effects can be identified and treated sooner. During this study, participants will wear an Alio Smartpatch™. The Alio Smartpatch™ is a wireless remote monitoring system. This device will measure participants' vital signs and blood levels. Participants will also be asked to use continuous glucose monitors to measure their glucose levels. The data collected on each participant from these devices will be remotely monitored at all times by clinical staff at a company known as Quantify Remote Care. If a participant's results look like they are experiencing a side effect, the participant will be contacted immediately by Quantify Remote Care team. The Quantify Remote Care team will function as an extension of the participant's cancer clinical team and will relay any significant issues back to them. Quantify Health also provides dietary and mental health support as needed for all participants.

Research Team

Naji Mallat, MD

Principal Investigator

Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center

Eligibility Criteria

This trial is for cancer patients at risk of febrile neutropenia, a condition with fever and low white blood cell count after chemotherapy. Participants should be willing to wear the Alio Smart Patch™ for continuous monitoring of vital signs and blood levels.

Inclusion Criteria

I am expected to undergo chemotherapy for at least 12 weeks.

I am able to understand and agree to the study's procedures and risks.

I am starting on immunotherapy alone or with chemotherapy for my treatment.

Exclusion Criteria

Participants without any cellphone access

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy and are continuously monitored using the Alio Smart Patch for up to 13 weeks

13 weeks

Continuous remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Alio Smart Patch™

Trial Overview The study tests if using the Alio Smart Patch™ can help detect and treat side effects from chemotherapy earlier by continuously monitoring vital signs and blood levels, including glucose, with remote supervision by Quantify Remote Care.

Participant Groups

Group I: Remote Monitoring with Smartpatch Experimental Treatment 1 Intervention

Participants will be continuously monitored through the device, providing crucial physiological data. The Smartpatch will allow for early detection of chemotherapy-related toxicities.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

The self-assessment smartphone app alerted 72.6% of users about concerning symptoms related to tobacco-induced diseases, with current smokers showing a higher incidence of symptoms like fatigue and cough, indicating a significant awareness of health issues.

During the study, the incidence of early-stage lung cancer (stages 1 and 2) increased to 24% among users, compared to 9% in the previous year, suggesting that the app may enhance early detection of lung cancer and encourage smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study. Stavaux, E., Goupil, F., Barreau, G., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The association between wearable device metrics and clinical outcomes in oncology: A systematic review with evidence synthesis and meta-analysis. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Engagement in an Interactive App for Symptom Self-Management during Treatment in Patients With Breast or Prostate Cancer: Mixed Methods Study. [2021]

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

Development of a novel remote patient monitoring system: the advanced symptom management system for radiotherapy to improve the symptom experience of patients with lung cancer receiving radiotherapy. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Digital Biomarkers of Symptom Burden Self-Reported by Perioperative Patients Undergoing Pancreatic Surgery: Prospective Longitudinal Study. [2023]

6. Poland pubmed.ncbi.nlm.nih.gov

New devices for very long-term ECG monitoring. [2019]

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

Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. [2022]

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

Zio® XT Patches in Pediatrics During the COVID-19 Pandemic: Comparisons Between In-Person and Mail-Home Application. [2023]

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

Comparison of Holter With Zio Patch Electrocardiography Monitoring in Children. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Improving stroke pathways using an adhesive ambulatory ECG patch: reducing time for patients to ECGs and subsequent results. [2022]