Lung CancerNCT01914120
the Quality of Life Assessment of Lung Cancer Patients in China
An observational study of Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510030
YuXiang Ma, 8602087343786, mayx@sysucc.org.cn
Li Zhang, professor
About this study
Official title: A Multicenter, Observational, Phase III Clinical Study: the Quality of Life Assessment of Lung Cancer Patients in China.
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.
Read the 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.
- Conditions
- Lung Cancer
- Keywords
- lung cancer, quality of life, FACT-L
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: Change from baseline quality of life at 6 weeks
Secondary outcomes (1)
overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Li Zhang, Professor, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914120
- Sponsor's protocol ID
- QLQ-CN
- Status last verified
- Aug 2015
- First submitted
- 28 Jul 2013
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26273367Zell 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.
PubMed 18090578Hopwood 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.
PubMed 7533520Lutz 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.
PubMed 11441624Vainio 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.
PubMed 8718910Temel 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.
PubMed 20818875Splinter 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.
PubMed 2177347Cella 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.
PubMed 7655830Hollen 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.
PubMed 8087439Cella 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.
PubMed 11864800Liu 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.
PubMed 35165103
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Observational, Phase III Clinical Study: the Quality of Life Assessment of Lung Cancer Patients in China.
- ClinicalTrials.gov ID
- NCT01914120
- Acronym / sponsor ID
- QLQ-CN
- Conditions
- Lung Cancer
- Keywords
- lung cancer, quality of life, FACT-L
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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;
1 secondary outcome
overall survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
- Background: PubMed 26273367Shi 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.
- Background: PubMed 18090578Zell 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.
- Background: PubMed 7533520Hopwood 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.
- Background: PubMed 11441624Lutz 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.
- Background: PubMed 8718910Vainio 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.
- Background: PubMed 20818875Temel 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.
- Background: PubMed 2177347Splinter 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.
- Background: PubMed 7655830Cella 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.
- Background: PubMed 8087439Hollen 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.
- Background: PubMed 11864800Cella 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.
- Derived from this study: PubMed 35165103Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Zhang, Professor principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YuXiang Ma (86-020-87343786, mayx@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of quality of life (time frame: Change from baseline quality of life at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01914120, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.