{"doc_desc":{"title":"Longitudinal Study on Behavioural, Economic and Sociological Changes Post-Cancer","idno":"FRESH-PEF8182-en","producers":[{"name":"Ang\u00e9lique BONNAUD-ANTIGNAC","affiliation":"NANTES UNIVERSITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8182-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8182"},{"agency":"FReSH","code":"FRESH-PEF8182"}]},"title":"Longitudinal Study on Behavioural, Economic and Sociological Changes Post-Cancer","alternate_title":"ELCCA"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Ang\u00e9lique;BONNAUD-ANTIGNAC","PILabo":"Universit\u00e9 de Nantes, Institut de Canc\u00e9rologie de \/ EA 4275 SPHERELaboratoire de biostatistique, de pharmaco\u00e9pid\u00e9miologie et de mesures subjectives en sant\u00e9","affiliationName":"NANTES UNIVERSITE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"089673786","role":"pi id"},{"title":"SIREN","uri":"130029747","role":"organisation id"},{"title":"RNSR","uri":"200815512F","role":"labo id"}],"email":"angelique.bonnaud@univ-nantes.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"INSTITUT DE CANCEROLOGIE DE L OUEST (ICO)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01m6as704","role":"sponsor id"},{"title":"SIREN","uri":"532254307","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rkrv905"},{"title":"SIREN","uri":"775664717"}]}]},"distribution_statement":{"contact":[{"name":"Ang\u00e9lique;BONNAUD-ANTIGNAC","email":"angelique.bonnaud@univ-nantes.fr","type":"contact","affiliationName":"NANTES UNIVERSITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/03gnr7b55","role":"organisation id","title":"ROR"},{"uri":"130029747","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"subjective well-being"},{"keyword":"post-cancer"},{"keyword":"medical"},{"keyword":"economic and psychological dimensions"},{"keyword":"Quality of life"}],"topics":[{"topic":"Oncology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"Malignant neoplasms of breast","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1047754165","title":"CIM-11"}]},{"topic":"Malignant melanoma, NOS","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/625791806","title":"CIM-11"}]},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"purpose":"The main objectives are: - To identify socio-economic (employment status, age, marital status, standard of living), psychological (PTG, anxiety, depression, coping) and clinical (stage, type of cancer treatment) determinants for changes in quality of life related to long- and short-term health and subjective well-being for people treated for cancer. - To determine if subjective well-being complements quality of life health assessment for cancer and post-cancer experience - To understand how subjectively perceived changes (posttraumatic growth) contribute to adaptation to the disease and its treatment and how they contribute to post-cancer experience. Issues regarding maintaining and returning to work will be investigated.","abstract":"","coll_dates":[{"start":"2010-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Pays de la Loire']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Individuals (men and women) diagnosed with primary cancer less than a month ago - Adults over 18 and under 65 years of age. The upper limit is fixed and will not be controlled by oncogeriatric specifics insofar as proposed treatments may differ according to age; - TNM Stage: I, II or III without distant metastasis; - Individual signed informed consent\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Quality of life\/health perception\r\nOthers"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"300: - 220 cancers du sein\/breast cancers - 80 m\u00e9lanomes\/melanomas"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"25-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"19-08-2014","isContributorPI":"No","contributorName":"Ang\u00e9lique BONNAUD-ANTIGNAC","contributorAffiliation":"NANTES UNIVERSITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/PUBMED-ELCCA"},{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/24315158"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Private non-profit"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Clinical services of the Institut de Canc\u00e9rologie de l\u2019Ouest (ICO, CLCC) and the onco-dermatology department in CHU H\u00f4tel-Dieu de Nantes"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}