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NCT06106360 | RECRUITING | Solid Tumor


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

Inova Health Care Services

Brief Summary:

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

Condition or disease

Solid Tumor

Hematological Malignancy

Intervention/treatment

Locus Health iPhone App

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
Estimated Enrollment : 100 participants
Official Title : A Pilot Prospective Clinical Trial Using Remote Patient Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy
Actual Study Start Date : 2023-10-26
Estimated Primary Completion Date : 2025-06-26
Estimated Study Completion Date : 2025-11-26

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT06106360


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Locations


RECRUITING

United States, Virginia

Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

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