Clinical trial NCT01914120: the Quality of Life Assessment of Lung Cancer Patients in China
Official title: A Multicenter, Observational, Phase III Clinical Study: the Quality of Life Assessment of Lung Cancer Patients in China.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: lung cancer
quality of life
FACT-L
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced non-small cell lung cancer patients diagnosed by pathological or cytological methods, and also have a imageological diagnosis within 6 weeks for clinical staging.

Clinical stage IIIB or IV. Chemo-naive patients: have never receive any kind of anti-cancer chemotherapy.

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.

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

Primary outcomes:
measure: the change of quality of life
timeFrame: Change from baseline quality of life at 6 weeks
Secondary outcomes:
measure: overall survival
timeFrame: 24 months
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
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