This randomized phase III trial studies personalized exercise program in improving cancer treatment in patients with stage I-IIIA non-small cell lung cancer or secondary lung cancer that can be removed by surgery. A personalized exercise program may help doctors find the best support rehabilitation for lung cancer, learn how exercise effects the rehabilitation process, and learn how to improve cancer treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03306992.
PRIMARY OBJECTIVE:
I. Evaluate the improvement in mobility performance.
SECONDARY OBJECTIVES:
I. Evaluate the improvement in strength, endurance, and balance.
II. Gather patient-reported outcomes regarding disease-specific symptoms, multidimensional fatigue, common mental health issues, and hypothesized treatment mechanisms and evaluate differences between arms.
EXPLORATORY OBJECTIVES:
I. Evaluate changes in biomarker levels, smoking status, microbiome, and body measurements.
II. Evaluate the rate of complications.
III. Measure the length of stay post-surgical resection.
IV. Evaluate costs of the personalized exercise program (PEP) intervention on health care utilization and costs from admission to discharge, from discharge to 2 months follow-up, and from 2 to 6 months follow-up.
V. Assess impact of coronavirus disease 2019 (COVID-19) on the study and participants.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive personalized home-based and inpatient exercise modes before and after surgery consisting of basic transfer and calisthenics mobility and aerobic and resistance exercises performed in various postures (supine, sitting, standing and walking) with variable challenges (level walking, bending, inclines, steps and squatting) for 6 months.
GROUP II: Patients receive standard of care and are encouraged to increase walking before and up to 6 months after surgery. After 6 months, patients will be offered personalized exercise program session with exercise counseling and receive activity tracker.
After completion of study, patients are followed up for 4 years.
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorCornelia Ulrich