Actively Recruiting

Age: 18Years +
All Genders
ID06106360

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

Led by Inova Health Care Services · Updated on 2025-12-08

100

Participants Needed

1

Research Sites

33 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of remote monitoring technology developed by Locus Health to track cancer patients undergoing outpatient chemotherapy. This pilot prospective clinical trial aims to assess the feasibility of using wearable devices like Apple Watches and the Locus Health iPhone app for early detection of chemotherapy-related toxicities. The study focuses on patient engagement with the technology, ease of use, and retention during treatment cycles for solid tumors and hematological malignancies. Participants are divided into three groups based on how frequently they receive symptom questions through the Locus Health app during their chemotherapy cycle. Cohort 1 receives daily queries from day 2 to the end of treatment, Cohort 2 receives daily queries from days 2 to 9 then every third day thereafter, and Cohort 3 receives daily queries for all symptoms from days 2 to 9, then every third day for pain only until the cycle ends. The study tracks adherence to using the Apple Watch and responding to app queries according to these schedules. During the study, participants are monitored for up to 120 days or until their chemotherapy regimen ends, whichever comes first. Researchers collect data on patient usage of the app and watch, symptom reporting, and user experience via questionnaires. The goal is to measure the feasibility of continuous remote monitoring and its ability to detect signs like fever or increased heart rate early, potentially leading to timely medical attention. Participants’ adherence and withdrawal rates are also tracked to assess the practicality of this approach in a real-world outpatient chemotherapy setting.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 120 days or until the chemotherapy regimen has stopped, whichever is sooner

Participants use the Locus Health iPhone App and Apple Watch to report symptoms and vital signs during outpatient chemotherapy. They are divided into three groups with different frequencies of symptom queries sent via the app to monitor chemotherapy-related toxicities.

Daily to every third day symptom reporting depending on cohort during chemotherapy cycles

Trial Site Locations

Total: 1 location

1

Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

Actively Recruiting

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Research Team

E

Elahe Mollapour

K

Keary Jane't

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Diagnosis and empirical treatment of fever of unknown origin (FUO) in adult neutropenic patients: guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO).

W J Heinz, D Buchheidt, M Christopeit...

https://pubmed.ncbi.nlm.nih.gov/28856437