{"doc_desc":{"title":"Etude longitudinale sur des femmes de plus de 65 ans survivantes d'un premier cancer du sein\/impact psychosocial","idno":"FRESH-PEF60039-fr","producers":[{"name":"Jean-Paul MOATTI","affiliation":"INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT (IRD)"}]},"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"}],"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":"http:\/\/id.nlm.nih.gov\/mesh\/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":"{\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\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"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\",\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":"['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\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels","conditions":"Condition d&#x27;acc\u00e8s en ce qui concerne les questionnaires et les bases, la mise \u00e0 disposition \u00e0 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. 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":"12-08-2014","isContributorPI":false,"contributorName":"","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"}