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Trial Title:
A Pilot Prospective Clinical Trial Using Remote Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy
NCT ID:
NCT06106360
Condition:
Solid Tumor
Hematological Malignancy
Conditions: Official terms:
Hematologic Neoplasms
Conditions: Keywords:
Wearable Electronic Devices
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Locus Health iPhone App
Description:
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.
Arm group label:
3 Cohorts
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.
Criteria for eligibility:
Study pop:
Patients with a wide range of solid tumor and malignant hematology malignancies will be
enrolled
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Inova Schar Cancer Institute
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elahe Mollapour
Phone:
571-472-4724
Email:
elahe.mollapour@inova.org
Contact backup:
Last name:
Keary Jane't
Email:
keary.janet@inova.org
Investigator:
Last name:
John Deeken, MD
Email:
Principal Investigator
Investigator:
Last name:
Jasmine Huynh, MD
Email:
Sub-Investigator
Investigator:
Last name:
Melisa Yacur, MD
Email:
Sub-Investigator
Start date:
October 26, 2023
Completion date:
November 26, 2025
Lead sponsor:
Agency:
Inova Health Care Services
Agency class:
Other
Source:
Inova Health Care Services
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06106360
