{"doc_desc":{"title":"Etude transversale sur la vie deux ans apr\u00e8s le cancer","idno":"FRESH-PEF8693-fr","producers":[{"name":"Patrick PERETTI-WATEL","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8693-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8693"},{"agency":"FReSH","code":"FRESH-PEF8693"}]},"title":"Etude transversale sur la vie deux ans apr\u00e8s le cancer","alternate_title":"VICAN 2"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Patrick;PERETTI-WATEL","firstname":"Patrick","lastname":"PERETTI-WATEL","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"patrick.peretti-watel@inserm.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"UMR912 (SE4S) INSERM","isContact":true}],"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"},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32","role":"sponsor id"},{"title":"SIREN","uri":"187512777","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CAISSE NATIONALE DE L'ASSURANCE MALADIE (CNAM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03am7sg53"},{"title":"SIREN","uri":"180035024"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]},{"name":"MUTUALITE SOCIALE AGRICOLE (MSA)","extlink":[{"title":"SIREN","uri":"302731054"}]}]},"distribution_statement":{"contact":[{"name":"Patrick;PERETTI-WATEL","lastname":"PERETTI-WATEL","firstname":"Patrick","type":"contact","email":"patrick.peretti-watel@inserm.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Cancer"},{"keyword":"sein"},{"keyword":"voies a\u00e9ro-digestives sup\u00e9rieures"},{"keyword":"prostate"},{"keyword":"c\u00f4lon-rectum"},{"keyword":"vessie"},{"keyword":"LMNH"},{"keyword":"col de l\u2019ut\u00e9rus"},{"keyword":"corps de l\u2019ut\u00e9rus"},{"keyword":"syst\u00e8me de soins"},{"keyword":"consommations de soins"},{"keyword":"\u00e9tat clinique"},{"keyword":"les effets physiques et psychiques persistants"},{"keyword":"cons\u00e9quences sociales"},{"keyword":"emploi"},{"keyword":"int\u00e9gration sociale"},{"keyword":"poumon"},{"keyword":"rein"},{"keyword":"thyro\u00efde"},{"keyword":"m\u00e9lanome"},{"keyword":"ALD"},{"keyword":"conditions de vie"},{"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","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"L'objectif g\u00e9n\u00e9ral est de d\u00e9crire les conditions de vie deux ans apr\u00e8s un diagnostic de cancer avec : \u2014 la perception de la maladie par les personnes touch\u00e9es et de leurs relations avec les professionnels de sant\u00e9 (verbalisation du diagnostic, perception de la gu\u00e9rison, annonce de la maladie, acc\u00e8s \u00e0 l\u2019information, participation au choix du traitement) ; \u2014 la qualit\u00e9 de vie deux ans apr\u00e8s le d\u00e9but de la maladie, des difficult\u00e9s psychologiques rencontr\u00e9es et des soutiens professionnels obtenus ; \u2014 les cons\u00e9quences sur la vie sociale (activit\u00e9 professionnelle, ressources, discrimination) et sur la vie priv\u00e9e (relations de couple, vie sexuelle, parentalit\u00e9, aide des proches).","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2013-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\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\": \"Avoir eu une mise en ALD entre le 01\\\/01\\\/2010 et le 30\\\/06\\\/2010, pour l\u2019une des localisations canc\u00e9reuses s\u00e9lectionn\u00e9es, avoir plus de 18 ans au moment du diagnostic.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant 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']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Stratified\",\"vocab\":\"CESSDA\"},\"value\":\"Probabiliste : stratifi\u00e9\"}']","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":"[1000-10000[ individus","response_rate":"4349"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","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":"23-04-2014","lastUpdatedAuto":null,"lastUpdatedManual":"11-05-2015","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Modalit\u00e9 de recueil des donn\u00e9es : - Enqu\u00eate t\u00e9l\u00e9phonique aupr\u00e8s des r\u00e9pondants avec possibilit\u00e9 de questionnaires auto-administr\u00e9s pour les localisations voies a\u00e9ro-digestives sup\u00e9rieures et poumon. - Enqu\u00eate par questionnaires aupr\u00e8s des m\u00e9decins en charge des personnes. - Appariement avec les donn\u00e9es de consommation de soins du SNIIR-AM. 3 types de recueils de donn\u00e9es : - enqu\u00eate transversale par t\u00e9l\u00e9phone\/questionnaires aupr\u00e8s des personnes - enqu\u00eate m\u00e9dicale par questionnaires aupr\u00e8s des \u00e9quipes m\u00e9dicales en charge de la personne - donn\u00e9es de consommations de soins (donn\u00e9es SNIIR-AM)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France M\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"Caract\u00e9ristiques initiales du cancer, donn\u00e9es de consommation de soin, co-morbidit\u00e9s, d\u00e9tail de la prise en charge th\u00e9rapeutique","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"}