A Multicenter, Observational, Phase III Clinical Study: the Quality of Life Assessment of Lung Cancer Patients in China.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- the change of quality of life
Study 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
- 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.
- The recruitment will take place in 20 center all over the country and 500 patients will enrolled.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Li Zhang
Profressor
Sun Yat-sen University