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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106360
• Other study ID #: U23-08-5132
• Status: Recruiting
• Start date: October 26, 2023
• Est. completion date: November 26, 2025

Study information

• Verified date: February 2024
• Source: Inova Health Care Services
• Contact: Elahe Mollapour
• Phone: (571) 472-4724
• Email: elahe.mollapour[@]inova.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 26, 2025
• Est. primary completion date: June 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
United States	Inova Schar Cancer Institute	Fairfax	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 treat — View Citation

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. — View Citation

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: 10.110 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	120 days or until the chemotherapy regimen has stopped, whichever is sooner