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Clinical Trials/NCT02835066
NCT02835066
Withdrawn
Not Applicable

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

Wake Forest University Health Sciences1 site in 1 countryJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking
Sponsor
Wake Forest University Health Sciences
Locations
1
Primary Endpoint
Patient function/fitness
Status
Withdrawn
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
July 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed lung cancer

Exclusion Criteria

  • Previous or active lung cancer treatment at the time of registration

Outcomes

Primary Outcomes

Patient function/fitness

Time Frame: Up to 6 months

Assessed by performance-based measures.

Patient well-being

Time Frame: Up to 6 months

Assessed by psychosocial health questions.

Study Sites (1)

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