NCT01914120

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

4.1 years

First QC Date

July 28, 2013

Last Update Submit

August 26, 2015

Conditions

Lung Cancer

Keywords

lung cancerquality of lifeFACT-L

Outcome Measures

Primary Outcomes (1)

  • the change of quality of life

    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;

    Change from baseline quality of life at 6 weeks

Secondary Outcomes (1)

  • overall survival

    24 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510030, China

RECRUITING

Related Publications (11)

  • 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.

    PMID: 26273367BACKGROUND

  • 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.

    PMID: 18090578BACKGROUND

  • 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.

    PMID: 7533520BACKGROUND

  • 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.

    PMID: 11441624BACKGROUND

  • 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.

    PMID: 8718910BACKGROUND

  • 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.

    PMID: 20818875BACKGROUND

  • 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.

    PMID: 2177347BACKGROUND

  • 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.

    PMID: 7655830BACKGROUND

  • 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.

    PMID: 8087439BACKGROUND

  • 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.

    PMID: 11864800BACKGROUND

  • 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.

    PMID: 35165103DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Li Zhang, Professor

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YuXiang Ma

CONTACT

86-020-87343786mayx@sysucc.org.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profressor

Study Record Dates

First Submitted

July 28, 2013

First Posted

August 1, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

August 27, 2015

Record last verified: 2015-08

Locations

CN(1)