NCT04878952

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: NRG Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Non-small Cell Lung Cancer
• Non-small Cell Lung Cancer Stage III
• Recurrent Non Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Garmin Vivofit Activity Tracker	Activity tracker that is worn on the wrist.

Timeline

• Start date: 2021-08-26
• Primary completion: 2024-08-12
• Completion: 2024-08-12
• First posted: 2021-05-10
• Last updated: 2024-09-04

Locations

5 sites across 1 country: United States