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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-26

Study Completion Date

2026-06-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Validation of a Novel Adherence Method for Oral Oncolytics

NCT03561272

Cancer

COMPLETED NA

Supportive Care Delivered by Telemedicine to Cancer Patients at Home

NCT04136340

Cancer Supportive Care

COMPLETED NA

Paclitaxel Therapeutic Drug Monitoring in Cancer Patients

NCT03987555

Stage IVA Cervical Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 +25 more

RECRUITING

Polyglutamate Camptothecin in Treating Patients With Advanced Cancer

NCT00059917

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma

NCT03229083

Advanced Renal Cell Carcinoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumor Hematological Malignancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Locus Health iPhone App

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No