A Pilot Prospective Clinical Trial Using Remote Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInova Health Care Services
About this trial
A pilot study using remote monitoring technology developed by Locus Health in cancer patients undergoing chemotherapy treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with a wide range of solid tumor and malignant hematology malignancies will be enrolled
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Locus Health iPhone App
DeviceIn 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: 3 Cohorts1 intervention
Trial outcomes
Primary outcomes
1
The Use of Locus Heath iPhone App and the Apple Watch by Participants Undergoing Outpatient Chemotherapy.
The feasibility is determined when 80% of the patients wear the watch at least 70% of the time during waking hours.
Time frame
120 days or until the chemotherapy regimen has stopped, whichever is soonerSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov