{"doc_desc":{"title":"Etude longitudinale sur des femmes de moins de 40 ans survivantes d'un premier cancer du sein\/impact psychosocial","idno":"FRESH-PEF60040-fr","producers":[{"name":"Jean-Paul MOATTI","affiliation":"INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT (IRD)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60040-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60040"},{"agency":"FReSH","code":"FRESH-PEF60040"}]},"title":"Etude longitudinale sur des femmes de moins de 40 ans survivantes d'un premier cancer du sein\/impact psychosocial","alternate_title":"ELIPPSE 40"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Jean-Paul;MOATTI","firstname":"Jean-Paul","lastname":"MOATTI","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05q3vnk25","role":"organisation id"},{"title":"SIREN","uri":"180006025","role":"organisation id"}],"email":"","affiliationName":"INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT (IRD)","PILabo":"IRD","isContact":false},{"name":"Dominique;REY","firstname":"Dominique","lastname":"REY","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSERM \/ U912","isContact":false}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"FONDATION ARC POUR LA RECHERCHE SUR LE CANCER","extlink":[{"title":"SIREN","uri":"752064949"}]},{"name":"FONDATION DE FRANCE","extlink":[{"title":"SIREN","uri":"784314908"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]},{"name":"MINISTERE DE L\u2019ENSEIGNEMENT SUPERIEUR, DE LA RECHERCHE ET DE L\u2019ESPACE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03sjk9a61"},{"title":"SIREN","uri":"110044013"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"REGION PACA","extlink":[{"title":"SIREN","uri":"231300021"}]},{"name":"CANCEROP\u00d4LE"}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"rechute"},{"keyword":"v\u00e9cu des effets secondaires"},{"keyword":"vie apr\u00e8s \u00e9pisode aig\u00fc"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"d\u00e9c\u00e8s"}],"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":"Gyn\u00e9cologie et obst\u00e9trique","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7de64596-5b0d-4977-8f98-b982ff2ec17d"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/284ca20c-beb4-4abe-99fa-ef4513358bad"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006176"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009774"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : \u00e9tudier - la qualit\u00e9 de vie \u00e0 long terme et la survie (5 \u00e0 10 ans) chez les survivantes de moins de 40 ans (18 \u00e0 40 ans) d'un cancer du sein en r\u00e9gion PACA. - l'impact du cancer et de ses traitements sur le projet reproductif - le retentissement sur les enfants - r\u00e9insertion professionnelle, acc\u00e8s \u00e0 un premier emploi - image du corps - observance au traitement, et en particulier \u00e0 l'hormonoth\u00e9rapie - acc\u00e8s aux pr\u00eats et assurances","abstract":"","coll_dates":[{"start":"2005-01-01","end":"2015-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Corse','Provence - Alpes - C\u00f4te d\\'Azur']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\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\": \"Femmes ayant fait l\u2019objet d\u2019une d\u00e9claration d\u2019affection de longue dur\u00e9e (ALD) pour un cancer du sein confirm\u00e9 par biopsie entre juillet 2005 et juillet 2011, \u00e2g\u00e9es de 18 \u00e0 40 ans et vivant en r\u00e9gion PACA ou en Corse. \",\n    \"clusion_E\": \"Les femmes ayant des m\u00e9tastases \u00e0 distance au moment du diagnostic ou pr\u00e9sentant des maladies psychiatriques s\u00e9v\u00e8res ont \u00e9t\u00e9 exclues, ainsi que celles qui \u00e9taient incapables de r\u00e9pondre \u00e0 un questionnaire t\u00e9l\u00e9phonique.\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour au dossier source ou retour vers le patient']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Qualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\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":"377"},"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":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels","conditions":"Pour les \u00e9quipes acad\u00e9miques Condition d&#x27;acc\u00e8s en ce qui concerne les questionnaires et les bases, la mise a disposition pour d&#x27;autres \u00e9quipes n&#x27;est envisageable qu&#x27;a la fin des \u00e9tudes et apr\u00e8s notre propre exploitation des donn\u00e9es, sauf en cas de collaboration directe sur des th\u00e9matiques particuli\u00e8res. Pour les industriels Condition d&#x27;acc\u00e8s la collaboration avec des industriels pourrait \u00eatre envisag\u00e9e ponctuellement sur la base d&#x27;\u00e9tudes pr\u00e9cises mais sans soutien structurel","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"25-07-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"List of publications in Pubmed","link":"http:\/\/tinyurl.com\/Pubmed-ELIPPSE-40"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif","Public (France)","Public (France)","Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"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":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle) Entretiens : saisie directe Examens cliniques : \u00e9tape manuscrite (saisie manuelle)Interviews par t\u00e9l\u00e9phone via une m\u00e9thode CATI (collecte assist\u00e9e par ordinateur)Collecte de donn\u00e9es tous les ans","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"R\u00e9gion PACA et Corse"},"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"}