Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT01914120
Status:
UNKNOWN
Last Update Posted:
2015-08-27
First Post:
2013-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Quality of Life Assessment of Lung Cancer Patients in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-26', 'studyFirstSubmitDate': '2013-07-28', 'studyFirstSubmitQcDate': '2013-07-31', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change of quality of life', 'timeFrame': 'Change from baseline quality of life at 6 weeks', 'description': 'use Functional Assessment of Cancer Therapy-Lung (FACT-L) scales assess the quality of life to all subjects.\n\nbefore chemotherapy; after 1st chemotherapy; after 2nd chemotherapy;'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lung cancer', 'quality of life', 'FACT-L'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '26273367', 'type': 'BACKGROUND', 'citation': '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': '18090578', 'type': 'BACKGROUND', 'citation': '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': '7533520', 'type': 'BACKGROUND', 'citation': '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': '11441624', 'type': 'BACKGROUND', 'citation': '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': '8718910', 'type': 'BACKGROUND', 'citation': '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': '20818875', 'type': 'BACKGROUND', 'citation': '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': '2177347', 'type': 'BACKGROUND', 'citation': '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': '7655830', 'type': 'BACKGROUND', 'citation': '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': '8087439', 'type': 'BACKGROUND', 'citation': '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': '11864800', 'type': 'BACKGROUND', 'citation': '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': '35165103', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n2. The recruitment will take place in 20 center all over the country and 500 patients will enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nClinical stage IIIB or IV. Chemo-naive patients: have never receive any kind of anti-cancer chemotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: \\>18 and \\<75 years old\n* pathological or cytological diagnosis confirmed advanced non-small cell lung cancer\n* Eastern Cooperative Oncology Group Performance Status: 0-2\n* have never receive any kind of anti-cancer chemotherapy\n* agree to regularly assessment of quality of life\n* sign the informed consent form\n\nExclusion Criteria:\n\n* Currently attending any antitumor drug clinical trials\n* Pregnancy or breast-feeding women\n* Currently receiving anti-tumor chemotherapy, or received any antitumor chemotherapy previously.\n* not suitable to participate in this test'}, 'identificationModule': {'nctId': 'NCT01914120', 'briefTitle': 'the Quality of Life Assessment of Lung Cancer Patients in China', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Multicenter, Observational, Phase III Clinical Study: the Quality of Life Assessment of Lung Cancer Patients in China.', 'orgStudyIdInfo': {'id': 'QLQ-CN'}}, 'contactsLocationsModule': {'locations': [{'zip': '510030', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'YuXiang Ma', 'role': 'CONTACT', 'email': 'mayx@sysucc.org.cn', 'phone': '8602087343786'}, {'name': 'Li Zhang, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'YuXiang Ma', 'role': 'CONTACT', 'email': 'mayx@sysucc.org.cn', 'phone': '86-020-87343786'}], 'overallOfficials': [{'name': 'Li Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profressor', 'investigatorFullName': 'Li Zhang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}