Recruiting

Remote Monitoring

Sponsor:

Inova Health Care Services

Code:

NCT06106360

Conditions

Solid Tumor

Hematological Malignancy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Locus Health iPhone App

Study Details

Brief summary:

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

Conditions

Solid Tumor

Hematological Malignancy

Study ID

NCT06106360

Start date

Oct 26, 2023

Status verified date

Dec, 2025

Completion date

Jun 26, 2026

Anticipated

Primary completion date

Nov 1, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Elahe Mollapour

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

Keary Jane't

Keary.Janet@inova.org

Locations

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Elahe Mollapour

571-472-4724elahe.mollapour@inova.org

Keary Jane't

keary.janet@inova.org

Principal Investigator:

John Deeken, MD

More Information

Sponsor

Inova Health Care Services

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Keywords

  • Wearable Electronic Devices

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2025-12-08.