NCT06106360

A Pilot Prospective Clinical Trial Using Remote Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy

A Pilot Prospective Clinical Trial Using Remote Patient Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A pilot study using remote monitoring technology developed by Locus Health in cancer patients undergoing chemotherapy treatment.

Detailed description

Modern-day wearable devices, such as Apple Watches or Fitbits, are widely available, non-invasive, and can provide continuous vital sign monitoring for the early detection of potential health complications. Early detection of things such as fever or increased heart rate can alert patients to seek medical attention sooner and therefore have the potential to improve patient outcomes and decrease healthcare costs. To further investigate the feasibility of using remote patient monitoring ( RPM)to prospectively monitor patients undergoing outpatient chemotherapy for chemotherapy related toxicities, defined as follows: (1) patients answer queries through the Locus Health iPhone app at least 70% of the time; (2) patients report that the Locus Health iPhone app and the Apple Watch were 'easy to use,' defined as an average score of 7 or higher on the first two questions of the post-intervention questionnaire, and (3) fewer than 10% of patients withdraw from the study.

Conditions

• Solid Tumor
• Hematological Malignancy

Interventions

Type	Name	Description
DEVICE	Locus Health iPhone App	In this pilot study patients are enrolled into three (3) different groups which will vary by the frequency of the queries being sent to the patients during their chemotherapy cycle. The patients will be separated into three groups of 33-34 patients each. Each group will have a different frequency of symptom questions sent to them via the Locus Health iPhone App to determine patient fatigue and the compliance impact of different query cadences. Patients will be assigned to these 3 groups sequentially since the platform could not assign patients to these three cohorts in a random manner.

Timeline

• Start date: 2023-10-26
• Primary completion: 2025-11-01
• Completion: 2026-06-26
• First posted: 2023-10-30
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study