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

NCT06106360 | Recruiting DMC FDA Device

• 1 other identifier: U23-08-5132
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematological Malignancy; Solid Tumor

Keywords

Wearable Electronic Devices

Outcome Measures

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.

  120 days or until the chemotherapy regimen has stopped, whichever is sooner

Study Arms (1)

3 Cohorts

Cohort 1: Daily from day 2 through the end of treatment cycle (n=34) Cohort 2: Daily days 2-9 then every third day through end of cycle (n=33) Cohort 3: Daily days 2-9 for all symptoms, every third day thereafter regarding 'pain' only through end of cycle (n=33)

Device: Locus Health iPhone App

Interventions

Locus Health iPhone App DEVICE

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.

3 Cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a wide range of solid tumor and malignant hematology malignancies will be enrolled

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

RECRUITING

Related 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 treatment of fever of unknown origin (FUO) in adult neutropenic patients: guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO). Ann Hematol. 2017 Nov;96(11):1775-1792. doi: 10.1007/s00277-017-3098-3. Epub 2017 Aug 30.

  PMID: 28856437 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• John Deeken, MD

  Inova Schar Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elahe Mollapour

CONTACT

(571) 472-4724; elahe.mollapour@inova.org

Keary Jane't

CONTACT

Keary.Janet@inova.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 120 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: October 26, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): June 26, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The Apple/Locus Health RPM intervention will end and the patient will come off study when the chemotherapy regimen is stopped for any reason.
• Access Criteria: All patient records and end-of study questionnaires will be de-identified using a letter and number assigned to their case at the time of enrollment on study. No record used for the data analysis will contain information which could identify the patient. Only the delegated research team will have access to the 'key' which connects patient identifiable information with this assigned number For computer records, the key will be protected by a double-password protection system. Any paper records will be contained in a locked cabinet within a locked office to ensure patients' privacy is protected.

Locations

US (1)