{"doc_desc":{"title":"Observational study on compliance, social consequences, management and costs of oral therapy in advanced or metastatic ErbB2+ (HER2+) breast cancer","idno":"FRESH-PEF149-en","producers":[{"name":"Christel LECLERC-ZWIRN","affiliation":"GLAXOSMITHKLINE (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF149-en","IDno":{"metadata_no":[{"agency":"PEF","code":"149"},{"agency":"FReSH","code":"FRESH-PEF149"}]},"title":"Observational study on compliance, social consequences, management and costs of oral therapy in advanced or metastatic ErbB2+ (HER2+) breast cancer","alternate_title":"CHORALE"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Christel;LECLERC-ZWIRN","PILabo":"Laboratoire GSK","affiliationName":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"592052146","role":"organisation id"},{"title":"","uri":"","role":"labo 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  },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"\u2022 Adult patient with metastatic breast cancer overexpressing Her2 \u2022 Patient for whom oral therapy (other than hormone therapy) has to be initiated on the day of inclusion (alone or combined with targeted therapeutic or cytotoxic chemotherapy administered intravenously).  \u2022 Subject accepting to participate in the survey\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, 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