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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
Activity tracker that is worn on the wrist.
WellSpan Health - Chambersburg
Chambersburg, Pennsylvania, United States
WellSpan Health - Ephrata
Ephrata, Pennsylvania, United States
WellSpan Health - Gettysburg
Gettysburg, Pennsylvania, United States
WellSpan Health - Lebanon
Lebanon, Pennsylvania, United States
Occurrence of hospital admission
Occurrence of hospital admission during radiation treatment or within 1 month after radiotherapy completion.
Time frame: From study enrollment to 1 month after radiotherapy completion.
Occurrence of emergency room visit lasting more than 24 hours
Occurrence of emergency room visit lasting more than 24 hours during radiation treatment or within 1 month after radiotherapy completion.
Time frame: From study enrollment to 1 month after radiotherapy completion.
Occurrence of radiation treatment interruption
Occurrence of of radiation treatment interruption (missing two or more treatments, not due to machine issues or scheduled holidays) during radiation treatment.
Time frame: From study enrollment to radiotherapy completion.
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WellSpan Health - York
York, Pennsylvania, United States