{"doc_desc":{"title":"COHORT ON HEALTH-RELATED QUALITY OF LIFE IN GYNAECHOLOGIC ONCOLOGY","idno":"FRESH-PEF8137-en","producers":[{"name":"Rajeev RAMANAH","affiliation":"CHU BESANCON (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8137-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8137"},{"agency":"FReSH","code":"FRESH-PEF8137"}]},"title":"COHORT ON HEALTH-RELATED QUALITY OF LIFE IN GYNAECHOLOGIC ONCOLOGY","alternate_title":"GYNEQOL"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Charles;COUTANT","PILabo":"Centre Georges-Fran\u00e7ois","affiliationName":"CENTR GEORGES FRANCOIS LECLERC","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"144492067","role":"pi id"},{"title":"SIREN","uri":"778204271","role":"organisation id"},{"title":"RNSR","uri":"200014577Z","role":"labo id"}],"email":"ccoutant@cgfl.fr","isContact":"Yes"},{"type":"investigator","name":"Sandrine;DABAKUYO","PILabo":"Plateforme Nationale 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cancer"},{"keyword":"vulvar cancer"},{"keyword":"ovarian cancer"},{"keyword":"quality of life"},{"keyword":"sexuality"}],"topics":[{"topic":"Gynaecology and obstetrics","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":"Oncology","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":"Malignant neoplasms of female genital organs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/751805133","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"}],"purpose":"\u2022 Main objective To study factors (clinical, biological, sociodemographic, behavioural) associated with quality of life (QoL) in real-life situations, in patients with gynecologic cancers, namely endometrial cancer, cervical cancer, vulvar and vaginal cancer and ovarian cancer. \u2022 Secondary Objectives To describe patient characteristics at baseline and compare QoL data of cohort patients with European and French data To compare QoL of patients who have undergone surgery for endometrial and cervical cancer according to different surgical approaches: Laparoscopy versus laparotomy Robot-assisted versus conventional laparoscopic surgery To assess QoL over time and for the \"long-term\" in patients with ovarian cancer, particularly those receiving intraperitoneal perioperatory adjuvant chemotherapy To assess the impact of targeted therapies on the QoL of patients with cervical and ovarian cancer To analyse time up to QoL deterioration in ovarian cancer and to research factors associated with deterioration To determine if QoL is different depending on the histological type of endometrial cancer To compare QoL of patients who have received and have not received adjuvant CT after surgery and radiotherapy for endometrial cancer To evaluate the importance of early palliative care patients in QoL Validation of SAQ sexuality questionnaire in French","abstract":"","coll_dates":[{"start":"2015-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Bourgogne Franche-Comt\u00e9']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\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\": \"Selected pelvic cancers are cervical, uterine body, ovarian, vaginal and vulvar cancer, irrespective of histological type and stage: - Follow-up in Franche-Comt\u00e9 and the Georges Fran\u00e7ois Leclerc Centre in Dijon - Age: 18 years and over - good knowledge of French - Able to respond to questionnaires (no major cognitive impairment) - Living in Franche Comt\u00e9 and Burgundy at time of diagnosis - having given signed consent - Covered by Social Security\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic 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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