the Quality of Life Assessment of Lung Cancer Patients in China

• Conditions: Lung Cancer

• Registration Number: NCT01914120
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The goal of this study is assess the quality of life of advanced non-small cell lung cancer (NSCLC) patients who are undergoing first-line chemotherapy, analyze the current status and tendency of quality of life (QOL). The method is to use the Functional Assessment of Cancer Therapy-Lung (FACT-L) scales, assess the quality of life before the chemotherapy, after 1st cycle of chemotherapy and after 2nd cycle. After 3 time-points, investigators analyze all the subscales and constructs of FACT-L. The assumption is the quality of life will be better after 2 cycle of chemotherapy.

Detailed Description

1. Lung cancer is the most deadly cancer in the world, 85% lung cancer are non-small cell lung cancer (NSCLC). The quality of life of NSCLC patients become more and more important, because of most NSCLC is incurable.

2. The recruitment will take place in 20 center all over the country and 500 patients will enrolled.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-07-28
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-08-27
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• age: >18 and <75 years old
• pathological or cytological diagnosis confirmed advanced non-small cell lung cancer
• Eastern Cooperative Oncology Group Performance Status: 0-2
• have never receive any kind of anti-cancer chemotherapy
• agree to regularly assessment of quality of life
• sign the informed consent form

Exclusion Criteria

• Currently attending any antitumor drug clinical trials
• Pregnancy or breast-feeding women
• Currently receiving anti-tumor chemotherapy, or received any antitumor chemotherapy previously.
• not suitable to participate in this test

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the change of quality of life	Change from baseline quality of life at 6 weeks	use Functional Assessment of Cancer Therapy-Lung (FACT-L) scales assess the quality of life to all subjects.; before chemotherapy; after 1st chemotherapy; after 2nd chemotherapy;

Secondary Outcome Measures

Name	Time	Method
overall survival	24 months

Trial Locations

Locations (1)

Sun Yat-Sen University Cancer Center; 🇨🇳 GuangZhou, Guangdong, China