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

February 28, 2024 updated by: Inova Health Care Services

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Contact:
        • Principal Investigator:
          • John Deeken, MD
        • Sub-Investigator:
          • Jasmine Huynh, MD
        • Sub-Investigator:
          • Melisa Yacur, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with a wide range of solid tumor and malignant hematology malignancies will be enrolled

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3 Cohorts
Cohort 1: Daily from day 2 through the end of treatment cycle (n=34) Cohort 2: Daily days 2-9 then every third day through end of cycle (n=33) Cohort 3: Daily days 2-9 for all symptoms, every third day thereafter regarding 'pain' only through end of cycle (n=33)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
120 days or until the chemotherapy regimen has stopped, whichever is sooner

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: John Deeken, MD, Inova Schar Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2023

Primary Completion (Estimated)

June 26, 2025

Study Completion (Estimated)

November 26, 2025

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U23-08-5132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

  • Age, gender, race/ethnicity
  • Active Problem List
  • Past Medical History
  • Past Surgical History
  • Social History
  • Vital Measurements from each clinic visit
  • Lab Results
  • Medication Orders

If the patient is seen in the Emergency Room or hospitalized, the following data will be extracted:

  • ER/Hospital Based Problem List
  • ER/ Hospital reason for presentation/Admission
  • Hospital Admission Diagnoses

IPD Sharing Time Frame

The Apple/Locus Health RPM intervention will end and the patient will come off study when the chemotherapy regimen is stopped for any reason.

IPD Sharing Access Criteria

All patient records and end-of study questionnaires will be de-identified using a letter and number assigned to their case at the time of enrollment on study. No record used for the data analysis will contain information which could identify the patient. Only the delegated research team will have access to the 'key' which connects patient identifiable information with this assigned number For computer records, the key will be protected by a double-password protection system. Any paper records will be contained in a locked cabinet within a locked office to ensure patients' privacy is protected.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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