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

Withdrawn

• Conditions: Smoking; Lung Neoplasms

• Registration Number: NCT02835066
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2016-05-12
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-15
• Primary Completion: 2017-07
• Status Verified: 2018-07
• Study Completion: 2018-07
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Newly diagnosed lung cancer

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient function/fitness	Up to 6 months	Assessed by performance-based measures.
Patient well-being	Up to 6 months	Assessed by psychosocial health questions.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States