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Recruiting

NCT Number: NCT06106360

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location status: Recruiting

Location contact

Elahe Mollapour

CONTACT

[email protected]

571-472-4724

Jasmine Huynh, MD

SUB_INVESTIGATOR

John Deeken, MD

PRINCIPAL_INVESTIGATOR

Keary Jane't

CONTACT

[email protected]

Melisa Yacur, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Planned to be treated with a new cytotoxic chemotherapy or chemoimmunotherapy regimen for a solid tumor or malignant hematology condition for at least 4 months
  • ECOG performance status of 0-2
  • Age of 18 or older patient with any solid tumor or hematologic malignancy
  • English or Spanish speaker
  • Own an Apple iPhone
  • Capacity and willingness to provide informed consent

Exclusion criteria

  • Patients undergoing concurrent radiation since they will be seen on a daily basis by clinic care teams and are not likely to benefit from active remote patient monitoring
  • Patients unwilling or unable to comply with the protocol, including wearing the Apple Watch (including recharging daily) and answering queries on the Locus Health iPhone application per the protocol and study group cadence
  • Any condition for which in the Investigator's opinion would limit compliance with study requirements

Treatment and study plan

Locus Health iPhone App

Device

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.

Primary outcomes

  1. The Use of Locus Heath iPhone App and the Apple Watch by Participants Undergoing Outpatient Chemotherapy.

    Time frame: 120 days or until the chemotherapy regimen has stopped, whichever is sooner

    The feasibility is determined when 80% of the patients wear the watch at least 70% of the time during waking hours.

Study contacts

Contact information is provided by the study sponsor or research team.

Elahe Mollapour

CONTACT

[email protected]

(571) 472-4724

Keary Jane't

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 30, 2023
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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