Developing Artificial Intelligence-based Algorism to Predict Side Effects and Symptoms From 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

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-08

Study Completion Date

2026-06-30

Brief Summary

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In this study, the investigators obtain wearable disease based biomarkers from patients diagnosed with cancer and undergoing chemotherapy, and simultaneously measure patient self-reported adverse events through an app to evaluate chemotherapy completion rates, emergency room visits, and frequency of CTCAE adverse events.

The investigators will develop an artificial intelligence-based algorism that can predict patients' side effects based on biomarkers alone.

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Detailed Description

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In this study, patients diagnosed with lung, head and neck, and esophageal cancers and undergoing chemotherapy will be measured for self-reported side effects using a wearable device to collect biomarkers through an app, and the association between patient quality of life and side effects and biomarkers obtained from the wearable device will be analyzed. On the other hand, blood (EDTA 3cc) for pharmacogenomics testing will be tested once at any point during the study period as an indicator associated with side effects after chemotherapy.

Conditions

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Lung Cancer Head and Neck Cancer Esophageal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Neoadjuvant, Adjuvant Chemotherapy Arm

Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Neoadjuvant, Adjuvant chemotherapy.

Fitbit smartwatch

Intervention Type OTHER

Patients wear the wearable to check their biomarkers and use the application to assess their quality of life and side effects at one-week intervals.

Palliative Chemotherapy Arm

Patients diagnosed with lung, head and neck, or esophageal cancer and undergoing Palliative chemotherapy.

Fitbit smartwatch

Intervention Type OTHER

Patients wear the wearable to check their biomarkers and use the application to assess their quality of life and side effects at one-week intervals.

Interventions

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Fitbit smartwatch

Patients wear the wearable to check their biomarkers and use the application to assess their quality of life and side effects at one-week intervals.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 20 years of age or older
* Must have diagnosed with lung, head and neck, or esophageal cancer,

1. scheduled to receive their first treatment in preoperative or postoperative chemotherapy.
2. scheduled for systemic chemotherapy due to recurrence or metastasis.
* Eastern Cooperative Oncology (ECOG) performance status of 0 to 2.
* Patients who have access to a smartphone and can use the mobile app on their own.
* Understand the purpose of the study and agree to participate in the study.

Exclusion Criteria

* Patients who, in the judgment of the researcher, have difficulty using the application.
* Patients who are judged by the medical staff to be unable to participate in the study.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No