A Multicenter, Observational, Phase III Clinical Study: the Quality of Life Assessment of Lung Cancer Patients in China.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- the change of quality of life
- Last Updated
- 10 years ago
Overview
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.
Investigators
Li Zhang
Profressor
Sun Yat-sen University
Eligibility Criteria
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
Outcomes
Primary Outcomes
the change of quality of life
Time Frame: 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 Outcomes
- overall survival(24 months)