Accuracy of a Mobile Sensor-Based System for the Detection of Chemotherapy Toxicity in Older Adults With Cancer in a Developing Country

Patients with cancer in developing countries face considerable challenges in obtaining access to care due to a lack of human resources and infrastructure. This is particularly pressing for vulnerable populations such as older adults. In this setting, many patients receiving chemotherapy are unable to report the presence of toxicities, and adverse events can go unnoticed for considerable amounts of time. The goal of this study is to assess the accuracy of an objective patient-centered measure of physical function (the number of steps taken per day measured using an accelerometer-equipped smartphone) for the remote detection of chemotherapy toxicity in older adults. This study builds on a pilot trial showing that monitoring older patients remotely utilizing an accelerometer-equipped smartphone is feasible and acceptable, and that a decline in the number of steps detected using the device can be an early sign of chemotherapy toxicity. The hypothesis of this study is that a decline in the number daily steps from a prechemotherapy baseline, measured using an accelerometer-equipped smartphone, will be accurate for detecting chemotherapy toxicity in older adults with cancer. This study will evaluate the ability of a patient-centered measure (a decline in the number of daily steps compared with a pre-chemotherapy baseline) to identify the presence of clinically-significant chemotherapy-related toxicity in Mexican older adults with cancer starting first line chemotherapy. Patients will be provided with an accelerometer-equipped smartphone with an installed pedometer application. Baseline steps per day will be obtained and recorded before starting chemotherapy. The patients' steps will be monitored daily for the first three chemotherapy cycles and compared with baseline recordings. Patients will be contacted daily and chemotherapy toxicity will be assessed by a physician. If significant toxicities are identified, the patient will be prompted to seek medical attention. The optimal cutoff point for detecting chemotherapy toxicity utilizing a decline in the number of daily steps will be chosen and validated. The adherence and satisfaction with the intervention will also be evaluated. This study could improve current methods and transform the way in which cancer care is delivered by demonstrating that a simple patient-centered measure obtained using a commercially available smartphone can aid in the accurate identification of clinically significant toxicities among a vulnerable population such as older adults with cancer.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Tlalpan
      • Mexico City, Tlalpan, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥65 years old
  • Any solid tumor
  • Starting first-line chemotherapy
  • Adjuvant, metastatic or recurrent setting
  • Any socioeconomic and educational level

Exclusion Criteria:

  • Patients with walking disability
  • Bedridden patients (ECOG 3)
  • Second or subsequent line of chemotherapy
  • Inpatients
  • Patients receiving radiation concomitantly with chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote monitoring using Smartphone
Patients will be provided with a Global System for Mobile communications (GSM) accelerometer-equipped Android smartphone (specific model to be decided) with an installed open source, freely available pedometer application (Google Fit, Google, CA, United States) which will record their daily steps. Patients will receive daily calls from a research assistant to document the presence of clinically significant chemotherapy-related toxicity.

Patients will be instructed to carry the smartphone around their hips during waking hours, regardless of whether they are at home or outside (a nylon hip holster will be provided) and to keep it turned on at all times.

Daily steps will be recorded for at least seven days before the start of chemotherapy, and the median baseline number of daily steps will be calculated for each patient.

On the first day of chemotherapy, patients will receive side effect education as per standard of care. Patients will be instructed to continue carrying the smartphone daily as indicated for the entire duration of the first three chemotherapy cycles.

At the end of the follow-up period (or sooner in cases of early interruption of chemotherapy due to toxicity or disease progression; a change in chemotherapy regimen; or hospitalizations lasting ≥3 days), patients will rate their satisfaction with the intervention using a Likert-scale questionnaire and open-ended questions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: Three months
We will determine the diagnostic accuracy of percent decline in daily steps (index test) for detecting patient (pt) reported chemotherapy (CT) toxicity (Tox) (reference standard) using the area under the curve (AUC) of the receiver operating characteristic (ROC) curve.
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: Three months
Ratio of the number of days steps are uploaded (X) to the number of days (N) the pt was asked to carry the phone, reported as a percentage (X/N x100).
Three months
Patient Satisfaction
Time Frame: Three months
Percentage of pts reporting a high satisfaction with their experience carrying the smartphone
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Enrique Soto Pérez de Celis, MD,MSc, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2019

Primary Completion (Actual)

December 14, 2022

Study Completion (Actual)

December 14, 2022

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • GER-3037-19-22-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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