{"doc_desc":{"producers":[{"name":"Admin Fresh","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60039-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60039"},{"agency":"FReSH","code":"FRESH-PEF60039"}]},"title":"Etude longitudinale sur des femmes de plus de 65 ans survivantes d'un premier cancer du sein\/impact psychosocial","alternate_title":"ELIPPSE 65"},"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"},{"uri":"031742386","role":"pi id","title":"IdRef"}],"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 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":"REGION PACA","extlink":[{"title":"SIREN","uri":"231300021"}]},{"name":"CANCEROP\u00d4LE"}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"vie apr\u00e8s l'\u00e9pisode aig\u00fc"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"rechute"},{"keyword":"d\u00e9c\u00e8s"},{"keyword":"v\u00e9cu des effets secondaires"}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"D008495"}]},{"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 plus de 65 ans d'un cancer du sein dans les departements de Bouches-du-Rh\u00f4ne, Var, Alpes maritimes. - la place du cancer par rapport aux comorbidit\u00e9s - l'image du corps - l'observance au traitement, et en particulier \u00e0 l'hormonoth\u00e9rapie - les aides sociales, besoins, aidants","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2015-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Provence - Alpes - C\u00f4te d\\'Azur']","analysis_unit":"Individus","universe":"{\"level_sex_clusion_I\":[{\"value\":\"F\u00e9minin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Grand \u00e2ge (80 ans et plus)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Survivantes d'un premier cancer du sein \u00e2g\u00e9es de 65 ans et plus, faisant l'objet d'une d\u00e9claration ALD dans les trois d\u00e9partements de l'\u00e9tude\",\"clusion_E\":\"\"}","data_kind":"['Donn\u00e9es de sant\u00e9 rapport\u00e9es par les participants de l'\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":"338"},"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\"}]}","notes":""},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels","conditions":"Condition d'acc\u00e8s en ce qui concerne les questionnaires et les bases, la mise \u00e0 disposition \u00e0 d'autres \u00e9quipes n'est envisageable qu'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. Condition d'acc\u00e8s la collaboration avec des industriels pourrait \u00eatre envisag\u00e9e ponctuellement sur la base d'\u00e9tudes pr\u00e9cises mais sans soutien structurel.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"Import\u00e9e","creationDate":"08-03-2013","lastUpdatedManual":"12-08-2014","isContributorPI":"","contributorName":"Admin Fresh","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/Pubmed-ELIPPSE-65"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","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 Examens cliniques : \u00e9tape manuscrite (saisie manuelle) avec double saisie","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Bouches du Rh\u00f4ne, Vars, Alpes Maritimes"},"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"}