Monitoring temperature remotely in cancer patients at risk for fever
Remote Temperature Monitoring of Patients At Risk for Developing Fever
This study tests if using a remote thermometer to monitor cancer patients' temperatures can help prevent fevers and reduce hospital stays after chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AION Biosystems Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Schenectady, New York) |
| Trial ID | NCT06752512 on ClinicalTrials.gov |
What this trial studies
This program evaluates the effectiveness of remote temperature monitoring in cancer patients who are at risk of developing fever due to chemotherapy. Participants will wear a thermometer that continuously tracks their temperature and sends alerts to their phones if it exceeds a certain threshold. The study aims to determine if this monitoring can reduce hospital stays and assess the associated costs and billing codes. Researchers will compare patients who comply with the monitoring to those who do not to evaluate the impact on inpatient days.
Who should consider this trial
Good fit: Ideal candidates are cancer patients aged 18 and older who are at risk of fever post-discharge and can use a smartphone for monitoring.
Not a fit: Patients who cannot provide informed consent or have a history of medical adhesive issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer hospitalizations and better management of fever in cancer patients undergoing chemotherapy.
How similar studies have performed: Other studies have shown promise in remote patient monitoring, particularly in managing chronic conditions, but this specific approach in cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is at risk of a fever post discharge. * Subject is ≥ 18 years or older. * Subject has an iOS or Android phone, or is able to operate an AION provided smartphone device. * Subject is willing to install the TempShield app on his/her phone. * Subject is willing to allow AION to send text reminders to take temperature or complete surveys. * Subject is willing to take an oral temperature as directed by their care plan. * Subject is willing to configure the phone to ensure these notifications are delivered, even when phone is in a "no notification" mode. * Subject or subject caretaker is able and willing to complete subject surveys. * Subject is willing and able to provide written informed consent in English. * Subject is willing and able to comply with all program procedures, requirements, assessments, visits, and complete questionnaires. * English speakers Exclusion Criteria: * Unable to provide informed consent * Subjects with a history of Medical Adhesive-Related Skin Injury (MARSI) * Subjects with no available placement that avoids open wounds or traumatized skin (burns. Blisters. Etc.) * Non-English speakers: The mobile application is only currently available in English. Future development will include other languages. * Subjects receiving prophylactics that could induce fever. * Subjects with a silicon allergy * Subject does not have iOS or Android phone, and is unable to operate an AION provided smartphone device. * Subjects who are not willing to take an oral temperature per their care plan.
Where this trial is running
Schenectady, New York
- Ellis Hospital — Schenectady, New York, United States (Recruiting)
Study contacts
- Principal investigator: Tallat Mahmood, M.D. — Ellis Hospital
- Study coordinator: David Colburn, Ph.D.
- Email: d.alexander.colburn@aionbioystems.com
- Phone: (757) 641-2019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.