{"doc_desc":{"title":"Etude Longitudinale sur les Changements comportementaux, \u00e9conomiques et sociologiques apr\u00e8s un Cancer","idno":"FRESH-PEF8182-fr","producers":[{"name":"Ang\u00e9lique BONNAUD-ANTIGNAC","affiliation":"NANTES UNIVERSITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8182-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8182"},{"agency":"FReSH","code":"FRESH-PEF8182"}]},"title":"Etude Longitudinale sur les Changements comportementaux, \u00e9conomiques et sociologiques apr\u00e8s un Cancer","alternate_title":"ELCCA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Ang\u00e9lique;BONNAUD-ANTIGNAC","firstname":"Ang\u00e9lique","lastname":"BONNAUD-ANTIGNAC","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03gnr7b55","role":"organisation id"},{"title":"SIREN","uri":"130029747","role":"organisation id"}],"email":"angelique.bonnaud@univ-nantes.fr","affiliationName":"NANTES UNIVERSITE","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","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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","lastname":"BONNAUD-ANTIGNAC","firstname":"Ang\u00e9lique","type":"contact","email":"angelique.bonnaud@univ-nantes.fr","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":"bien-\u00eatre subjectif"},{"keyword":"apr\u00e8s-cancer"},{"keyword":"dimensions m\u00e9dicales"},{"keyword":"\u00e9conomiques et psychologiques"},{"keyword":"qualit\u00e9 de vie"}],"topics":[{"topic":"Oncologie","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":"Tumeurs malignes du sein","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1047754165","title":"CIM-11"}]},{"topic":"M\u00e9lanome malin, SAI","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/625791806","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"Les principaux objectifs sont: - D\u2019identifier les d\u00e9terminants socio\u00e9conomiques (statut professionnel, \u00e2ge, statut matrimonial, niveau de vie), psychologiques (PTG, anxi\u00e9t\u00e9-d\u00e9pression, coping) et cliniques (stade, type de cancer, traitements) de l\u2019\u00e9volution de la qualit\u00e9 de vie li\u00e9e \u00e0 la sant\u00e9 et du bien-\u00eatre subjectif sur le court terme et le long terme chez des personnes soign\u00e9es d\u2019un cancer. - De d\u00e9terminer si le bien-\u00eatre subjectif est compl\u00e9mentaire des mesures de qualit\u00e9 de vie li\u00e9e \u00e0 la sant\u00e9 sur l\u2019exp\u00e9rience de la maladie canc\u00e9reuse et de l\u2019apr\u00e8s cancer - De comprendre comment les changements per\u00e7us subjectivement (d\u00e9veloppement post-traumatique) participent d\u2019une adaptation \u00e0 la maladie et \u00e0 ses traitements et comment ils participent de la construction du v\u00e9cu de l\u2019apr\u00e8s-cancer. La probl\u00e9matique du maintien et du retour au travail sera \u00e9tudi\u00e9e.","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":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\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\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Personnes (homme et femme) dont le diagnostic de premier cancer a \u00e9t\u00e9 pos\u00e9 depuis moins d\u2019un mois - Personnes adultes, \u00e2g\u00e9es de plus de 18 ans et de moins de 65 ans. La limite sup\u00e9rieure est fix\u00e9e pour ne pas avoir \u00e0 contr\u00f4ler de sp\u00e9cificit\u00e9 li\u00e9e \u00e0 l\u2019oncog\u00e9riatrie dans la mesure o\u00f9 les traitements propos\u00e9s peuvent diff\u00e9rer en fonction de l\u2019\u00e2ge ; - Stade TNM : I, II voire III sans m\u00e9tastase \u00e0 distance ; - Consentement \u00e9clair\u00e9 et sign\u00e9 de la personne\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Qualit\u00e9 de vie\/sant\u00e9 per\u00e7ue\r\nAutres"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"300:- 220 cancers du sein\/breast cancers- 80 m\u00e9lanomes\/melanomas"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"25-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"19-08-2014","isContributorPI":false,"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":["Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"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":false},"geographicalCoverage":{"geoDetail":"Services cliniques de l\u2019Institut de Canc\u00e9rologie de l\u2019Ouest (ICO, CLCC) et d\u2019onco-dermatologie du CHU H\u00f4tel-Dieu de Nantes"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}