Testing the Addition of Activity Monitoring With a Wearable Electronic Device to Improve Patient Care During Treatment for Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title: Activity Monitoring to Improve Patient Care During Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer (LA-NSCLC)

Status Recruiting

Clinical Trial Summary

This trial will examine if the monitoring of daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse events during the course of radiation treatment.

Clinical Trial Description

PRIMARY OBJECTIVE:

To demonstrate that monitoring daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse clinical events during the radiotherapy course.

SECONDARY OBJECTIVES:

I. To demonstrate the feasibility of monitoring daily step counts during a course of chemoradiotherapy in the setting of a multi-institutional trial.

II. To examine the association between baseline activity level and clinical outcomes related to treatment tolerance, quality of life, chemoradiotherapy adverse events, and physical function preservation.

III. To demonstrate associations between daily step counts and short-term hospitalization risk.

IV. To explore predictors of step count decline during chemoradiotherapy among clinical factors and radiotherapy plan parameters.

EXPLORATORY OBJECTIVES:

I. To explore patterns of care regarding adjuvant immunotherapy administration following definitive chemoradiotherapy for locally advanced non-small cell lung cancer.

II. To examine the association between baseline activity level with progression free survival and overall survival.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Usual Care

ARM II: Usual Care + Continuous physical activity monitoring via a wearable device.

Patients randomized to undergo activity monitoring will use a wearable device from the time of study enrollment until four weeks after the completion of thoracic radiotherapy. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Non-small Cell Lung Cancer Stage III
• Recurrent Non Small Cell Lung Cancer

• NCT number: NCT04878952
• Study type: Interventional
• Source: NRG Oncology
• Contact: Nitin Ohri, MD
• Phone: 718-920-7750
• Email: nitin.ohri@einsteinmed.org
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Completion date: July 10, 2026