- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040881
Accuracy of a Mobile Sensor-Based System for the Detection of Chemotherapy Toxicity in Older Adults With Cancer in a Developing Country
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Enrique Soto Pérez de Celis, MD,MSc
- Phone Number: 5712 525554870900
- Email: enrique.sotop@incmnsz.mx
Study Locations
-
-
Tlalpan
-
Mexico City, Tlalpan, Mexico, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Collaborators
Investigators
- Principal Investigator: Enrique Soto Pérez de Celis, MD,MSc, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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