A Pilot Prospective Clinical Trial Using Remote Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Locus Health iPhone App.
- Who it may be relevant to
- Registry conditions: Solid Tumor, Hematological Malignancy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Prospective Clinical Trial Using Remote Patient Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy
Overview
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.
Interventions
- 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 sequenti
Primary outcome measures
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Inova Schar Cancer Institute — Fairfax
Publications
- Heinz WJ, Buchheidt D, Christopeit M, von Lilienfeld-Toal M, Cornely OA, Einsele H, Karthaus M, Link H, Mahlberg R, Neumann S, Ostermann H, Penack O, Ruhnke M, Sandherr M, Schiel X, Vehreschild JJ, Weissinger F, Maschmeyer G. 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 So PMID 28856437
- Kuderer NM, Dale DC, Crawford J, Cosler LE, Lyman GH. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer. 2006 May 15;106(10):2258-66. doi: 10.1002/cncr.21847. PMID 16575919
- Zimmer AJ, Freifeld AG. Optimal Management of Neutropenic Fever in Patients With Cancer. J Oncol Pract. 2019 Jan;15(1):19-24. doi: 10.1200/JOP.18.00269. PMID 30629902
- Verma N, Haji-Abolhassani I, Ganesh S, Vera-Aguilera J, Paludo J, Heitz R, Markovic SN, Kulig K, Ghoreyshi A. A Novel Wearable Device for Continuous Temperature Monitoring & Fever Detection. IEEE J Transl Eng Health Med. 2021 Jul 19;9:2700407. doi: 10.1109/JTEHM.2021.3098127. eCollection 2021. PMID 34765323
Identifiers
NCT: NCT06106360 · U23-08-5132