NCT02835066

Patient Function/Fitness and Psychosocial Health in Improving Health-Related Quality of Life in Patients With Stage I-IV Non-Small Cell Lung Cancer

A Pilot Study Investigating Patient Function/Fitness and Psychosocial Health in Patients With Non-Small Cell Lung Cancer

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot trial studies patient function/fitness and psychosocial health in improving health-related quality of life and decreasing treatment-related toxicity in patients with stage I-IV non-small cell lung cancer. Studying function/fitness and psychosocial health may help doctors improve conventional therapy in patients with non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the correlation of patient-reported health-related quality of life (HRQOL) outcomes with clinical/treatment variables as well as a panel of both function/fitness and psychosocial health assessments in non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To investigate the panel of function/fitness and psychosocial health assessments with patient's smoking history/status as a predictor for treatment related toxicity. TERTIARY OBJECTIVES: I. The documentation of the NSCLC lung population from this prospective combined with others. OUTLINE: Patients scheduled for surgery, radiation therapy, or chemotherapy complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-core 30 (C30) and QLQ-Lung Cancer 13 (LC13) in addition to psychosocial health and smoking status questions from baseline up to 2 weeks prior to the start of treatment, 5-6 weeks after treatment begins, and 5-6 months from the start of treatment. During the same time points, patients also undergo function/fitness assessments including standard health measurements, short physical performance battery (SPPB), 6 minute walk test (6MWT), and a grip strength test. After completion of study treatment, patients are followed up every 3-6 months.

Conditions

• Smoking
• Lung Neoplasms

Interventions

Type	Name	Description
OTHER	Integrated Fitness Assessment	Undergo function/fitness assessment
PROCEDURE	Psychosocial Assessment and Care	Undergo psychosocial health assessments
PROCEDURE	Quality-of-Life Assessment	Complete EORTC QLQ-C30 and QLQ-LC13 questionnaires

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-07-01
• Completion: 2018-07-01
• First posted: 2016-07-15
• Last updated: 2018-07-27

Locations

1 site across 1 country: United States