the Quality of Life Assessment of Lung Cancer Patients in China

NCT ID: NCT01914120

Last Updated: 2015-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Li Zhang

Profressor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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YuXiang Ma

Role: CONTACT

86-020-87343786

Facility Contacts

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YuXiang Ma

Role: primary

8602087343786

References

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Shi Y, Xing P, Fan Y, Zhang X, Hu C, Wang C, Liu X, Chen X, Zhou J, Wang M, Wu M, Han B, Fan M. Current small cell lung cancer treatment in China. Thorac Cancer. 2015 May;6(3):233-8. doi: 10.1111/1759-7714.12218. Epub 2015 Jan 15.

Reference Type BACKGROUND
PMID: 26273367 (View on PubMed)

Zell JA, Ignatius Ou SH, Ziogas A, Anton-Culver H. Validation of the proposed International Association for the Study of Lung Cancer non-small cell lung cancer staging system revisions for advanced bronchioloalveolar carcinoma using data from the California Cancer Registry. J Thorac Oncol. 2007 Dec;2(12):1078-85. doi: 10.1097/JTO.0b013e31815ba260.

Reference Type BACKGROUND
PMID: 18090578 (View on PubMed)

Hopwood P, Stephens RJ. Symptoms at presentation for treatment in patients with lung cancer: implications for the evaluation of palliative treatment. The Medical Research Council (MRC) Lung Cancer Working Party. Br J Cancer. 1995 Mar;71(3):633-6. doi: 10.1038/bjc.1995.124.

Reference Type BACKGROUND
PMID: 7533520 (View on PubMed)

Lutz S, Norrell R, Bertucio C, Kachnic L, Johnson C, Arthur D, Schwarz M, Palardy G. Symptom frequency and severity in patients with metastatic or locally recurrent lung cancer: a prospective study using the Lung Cancer Symptom Scale in a community hospital. J Palliat Med. 2001 Summer;4(2):157-65. doi: 10.1089/109662101750290191.

Reference Type BACKGROUND
PMID: 11441624 (View on PubMed)

Vainio A, Auvinen A. Prevalence of symptoms among patients with advanced cancer: an international collaborative study. Symptom Prevalence Group. J Pain Symptom Manage. 1996 Jul;12(1):3-10. doi: 10.1016/0885-3924(96)00042-5.

Reference Type BACKGROUND
PMID: 8718910 (View on PubMed)

Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.

Reference Type BACKGROUND
PMID: 20818875 (View on PubMed)

Splinter TA. Chemotherapy in advanced non-small cell lung cancer. Eur J Cancer. 1990;26(10):1093-9. doi: 10.1016/0277-5379(90)90059-3.

Reference Type BACKGROUND
PMID: 2177347 (View on PubMed)

Cella DF, Bonomi AE, Lloyd SR, Tulsky DS, Kaplan E, Bonomi P. Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. Lung Cancer. 1995 Jun;12(3):199-220. doi: 10.1016/0169-5002(95)00450-f.

Reference Type BACKGROUND
PMID: 7655830 (View on PubMed)

Hollen PJ, Gralla RJ, Kris MG, Cox C. Quality of life during clinical trials: conceptual model for the Lung Cancer Symptom Scale (LCSS). Support Care Cancer. 1994 Jul;2(4):213-22. doi: 10.1007/BF00365725.

Reference Type BACKGROUND
PMID: 8087439 (View on PubMed)

Cella D, Eton DT, Fairclough DL, Bonomi P, Heyes AE, Silberman C, Wolf MK, Johnson DH. What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol. 2002 Mar;55(3):285-95. doi: 10.1016/s0895-4356(01)00477-2.

Reference Type BACKGROUND
PMID: 11864800 (View on PubMed)

Liu J, Ma Y, Gao R, Liu X, Wang Y, Yu J, Zhan J, Huang Y, Qin H, Zhang L. Prognostic effects of health-related quality of life at baseline and early change in health-related quality of life on response to treatment and survival in patients with advanced lung cancer: a prospective observational study in China. BMJ Open. 2022 Feb 14;12(2):e047611. doi: 10.1136/bmjopen-2020-047611.

Reference Type DERIVED
PMID: 35165103 (View on PubMed)

Other Identifiers

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QLQ-CN

Identifier Type: -

Identifier Source: org_study_id

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