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

NCT05937477 | Recruiting

• 1 other identifier: 2023-02-057
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Head and Neck Cancer; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Developing artificial intelligence prediction algorism

  PRO data and treatment information collected from the wearable are used to evaluate correlations through methods such as linear regression to determine valid variables, utilizing LSTM models, etc.

  Through study completion, an average of 30 months

Study Arms (2)

Neoadjuvant, Adjuvant Chemotherapy Arm

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

Other: Fitbit smartwatch

Palliative Chemotherapy Arm

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

Other: Fitbit smartwatch

Interventions

Fitbit smartwatch 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.

Neoadjuvant, Adjuvant Chemotherapy Arm; Palliative Chemotherapy Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• years of age or older
• Must have diagnosed with lung, head and neck, or esophageal cancer,
• scheduled to receive their first treatment in preoperative or postoperative chemotherapy.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sehhoon Park: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnamgu, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Head and Neck Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Sehhoon Park, MD

CONTACT

+82-10-9185-8619; sehhoon.park@samsung.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D, Ph.D. Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 10, 2023
• Study Start: June 8, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

KR (1)