{"id":2222,"date":"2026-02-24T09:55:01","date_gmt":"2026-02-24T08:55:01","guid":{"rendered":"https:\/\/path-for-young.unicancer.fr\/?page_id=2222"},"modified":"2026-09-24T08:12:50","modified_gmt":"2026-09-24T06:12:50","slug":"taking-part-in-the-optima-young-clinical-trial-2","status":"publish","type":"page","link":"https:\/\/path-for-young.unicancer.fr\/fr\/optima-young-trial-2\/taking-part-in-the-optima-young-clinical-trial-2\/","title":{"rendered":"Taking Part in the Optima-young Clinical Trial"},"content":{"rendered":"\n<div class=\"wp-block-uagb-container uagb-block-24a39552 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\"><div class=\"plmb plmb-text mce-content clearfix format-intro\">\r\n\t<h1>Taking Part in the<br \/>\nOptima-young Clinical Trial<\/h1>\n<\/div>\r\n<\/div><\/div>\n\n\n<div class=\"plmb plmb-video\">\r\n\t\t<div class=\"video-inner\">\r\n\t\t<div class=\"video-container\">\r\n\t\t\t<iframe loading=\"lazy\" width=\"640\" height=\"360\" src=\"https:\/\/www.youtube.com\/embed\/9aBEl-ZI2ug?feature=oembed\" frameborder=\"0\" allowfullscreen><\/iframe>\t\t<\/div>\r\n\t\t\t<\/div>\r\n\t\t<\/div>\r\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-b3d760ae alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\"><div class=\"plmb plmb-text mce-content clearfix format-classic\">\r\n\t<h2 style=\"text-align: center\">Who can participate?<\/h2>\n<\/div>\r\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-a9a89e29 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\">\n<div class=\"wp-block-uagb-container uagb-block-c5b71dd8\">\n<div class=\"wp-block-uagb-container uagb-block-545eed50\"><div class=\"plmb plmb-text mce-content clearfix format-classic\">\r\n\t<h3>You can take part in the Optima Young study if:<\/h3>\n<p>Before proposing the study, the investigating physician (the medical professional who directs and supervises the conduct of research at a site), will check that all the parameters have been met for the patient to participate in Optima-young. The main parameters he will check are as follows:<\/p>\n<p><strong>Be a woman over 18 who has not yet reached menopause and whose breast cancer&nbsp;:<\/strong><\/p>\n<ul>\n<li>is hormone-dependent (HR+) and HER2-<\/li>\n<li>underwent surgery<\/li>\n<li>has spread to 1-9 lymph nodes under the arm and is of any size<\/li>\n<li>or has not spread to the lymph nodes but measures at least 2 cm<\/li>\n<li>if the cancer affects both breasts, it may be possible to participate. The situation will need to be discussed with the patient's care team.<\/li>\n<\/ul>\n<\/div>\r\n<\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-f7d8655f\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-775c4ea3\"><div class=\"plmb plmb-text mce-content clearfix format-classic resp-format-mob-title-center\">\r\n\t<h3>You cannot join Optima Young if any of these apply:<\/h3>\n<p>The patient may have been treated with hormone therapy if this was taken for less than 8 weeks prior to inclusion in the study. Hormone therapy uses drugs to block or reduce the amount of hormones in the body. The aim of hormone therapy is to slow or stop cancer growth.<\/p>\n<p>He will also have to check that the following main parameters do not apply to the patient.<\/p>\n<ul>\n<li>The cancer had spread to at least 10 lymph nodes under the arm.<\/li>\n<li>The cancer has spread to another part of the body - this is known metastatic or secondary breast cancer.<\/li>\n<li>The patient has already been treated with chemotherapy or radiotherapy for breast cancer.<\/li>\n<li>More than 12 weeks have passed since the operation.<\/li>\n<li>The surgeon has not completed the breast cancer operation. The patient may, however, participate in the trial if the surgeon has scheduled an operation to remove the breast completely (mastectomy) or part of the breast tissue after a few months.<\/li>\n<li>The patient has already been treated for another cancer, except in special cases: the situation should be discussed with the team treating the patient.<\/li>\n<li>The patient is menopausal.<\/li>\n<\/ul>\n<\/div>\r\n<\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-b014cec1 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\">\n<div class=\"wp-block-uagb-container uagb-block-b0488314\"><div class=\"plmb plmb-text mce-content clearfix format-classic\">\r\n\t<h2 style=\"text-align: center\">What does it mean to participate?<\/h2>\n<\/div>\r\n<\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-ff204447\">\n<div class=\"wp-block-uagb-container container-or uagb-block-a3a1b761\"><div class=\"plmb plmb-text mce-content clearfix format-classic\">\r\n\t<p style=\"text-align: center\"><span style=\"color: #05206d\"><strong><span style=\"font-size: 40px\">Group 1<\/span><\/strong><\/span><\/p>\n<p><strong>If you are in treatment group 1:<\/strong> you will receive standard treatment, i.e. the same treatment you would receive outside the research, i.e. chemotherapy and hormone therapy. Your tumor sample will be tested at a later date with the Prosigna<sup>\u00ae<\/sup> genomic test, so that the results of group 1 can be compared with those of group 2. The result of this test will not influence the treatment you receive in the study. Your treatment will last 5 years and may be extended after discussion with your doctor outside the study.<\/p>\n<\/div>\r\n<\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-3cb3dd61\"><div class=\"plmb plmb-text mce-content clearfix format-classic\">\r\n\t<p style=\"text-align: center\"><span style=\"font-size: 40px;color: #05206d\"><strong>Group 2<\/strong><\/span><\/p>\n<p>If you are in treatment group 2: A sample of your tumour (taken during surgery) will be sent to the centralized laboratory for analysis using the Prosigna test<sup>\u00ae<\/sup> . Then, a few days after your tumor sample is sent, your doctor will receive the treatment plan you should receive (based on the score given by the test)\u00a0:<\/p>\n<ul>\n<li>If the result is greater than 60, your breast cancer is considered by the Prosigna test to be sensitive to chemotherapy: you will receive chemotherapy and hormone therapy.<\/li>\n<li>If your result is less than or equal to 60, your breast cancer will be considered by the Prosigna test to be insensitive to chemotherapy: you will then receive hormone therapy without chemotherapy.<\/li>\n<\/ul>\n<\/div>\r\n<\/div>\n<\/div>\n\n\n<div class=\"plmb plmb-text mce-content clearfix format-classic\">\r\n\t<div>\n<p class=\"paragraph\" style=\"text-align: center\"><strong><span class=\"normaltextrun\"><span lang=\"EN-US\">Your treatment will last for 5 years and may be extended after discussion<br \/>\nwith your doctor outside the framework of the study.<\/span><\/span><span class=\"eop\"><span lang=\"EN-US\">\u00a0<\/span><\/span><\/strong><\/p>\n<\/div>\n<\/div>\r\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-8f72fe95\">\n<div class=\"wp-block-uagb-container uagb-block-fea93087\"><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-ef341cc1\"><div class=\"plmb plmb-text mce-content clearfix format-classic resp-format-tablet-title-center\">\r\n\t<h2>Sharing Your<br \/>\nExperience Through<br \/>\nHealth Questionnaires<\/h2>\n<p>In addition, throughout the study (4 times in the first year, then once a year for a total of 5 years), we will ask you to fill in questionnaires relating, among other things, to your perception of your state of health, will enable us analyze patients' experience and quality of life. We estimate that filling in these questionnaires will take between 30 minutes and 1 hour 15 minutes, depending on the number of questionnaires to be completed (allow an average of 5 minutes per questionnaire). These questionnaires will be accessible on an electronic platform: the WeShare platform, to which your medical team will give you access, or in hard copy if necessary.<\/p>\n<\/div>\r\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-aa196cac\"><div class=\"plmb plmb-path-accordion accordion-white\">\r\n\t<div class=\"path-accordion\">\r\n\t\t<h2><button type=\"button\" aria-expanded=\"false\" aria-controls=\"plmb-path-accordion-6ab5ae4270c26\">Are you a patient from France, Belgium, or Ireland?<\/button><\/h2>\r\n\t\t<div class=\"path-accordion-inner\" aria-labelledby=\"plmb-path-accordion-6ab5ae4270c26\" role=\"region\">\r\n\t\t\t<div class=\"path-accordion-content mce-content\">\r\n\t\t\t\t<p>If you are participating in the Optima-young study in France, Belgium or Ireland, you will have the opportunity to take part in the OPTIMIZE sub-study, which aims to evaluate the benefits of personalized follow-up using a digital tool developed by Gustave Roussy, a French hospital specialized in oncology, and Resilience, a French company specialized in this field, whatever your treatment group.<\/p>\n<p>The aim is evaluate the effectiveness of a digital companion (i.e. a cell phone application) in managing the symptoms and side effects associated with hormone therapy. You will be randomly assigned to one of two groups:<\/p>\n<h3><span style=\"color: #00b8b5\">Group A - Personalized digital monitoring<\/span><\/h3>\n<p>in addition to the standard follow-up provided by your oncology , you will have access to the Resilience digital tool, where you can:<\/p>\n<ul>\n<li>Evaluate your symptoms every month and your supportive care needs every six months;<\/li>\n<li>Access personalized educational content (videos, podcasts or articles) tailored to the symptoms and needs identified in the previous step;<\/li>\n<li>Be offered digital supportive care programs tailored to your needs, including physical activity, meditation, yoga and cognitive behavioral therapy* modules for fatigue, hot flashes and anxiety;<\/li>\n<li>Access your own information (program completion, symptom evolution and care needs), which will also be visible to your healthcare team improve communication between you and your caregivers.<\/li>\n<\/ul>\n<h3><span style=\"color: #00b8b5\">Group B - Standard follow-up without digital companion: <\/span><\/h3>\n<p>your follow-up will be the same as the usual care provided at your center. Depending on your center's usual practices, this may include participation in educational seminars, referral to local supportive care services or access to existing information resources (such as information websites or digital tools).<\/p>\n<p>&nbsp;<\/p>\n<div>\n<p class=\"paragraph\"><strong><span class=\"normaltextrun\"><span lang=\"EN-US\">We invite you to discuss your participation in this substudy with your investigator. If you wish to participate, please check the corresponding box on the consent form to confirm your agreement to participate.<\/span><\/span><span class=\"eop\"><span lang=\"EN-US\">\u00a0<\/span><\/span><\/strong><\/p>\n<\/div>\n\t\t\t<\/div>\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div>\r\n<\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-9167a2aa alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\">\n<div class=\"wp-block-uagb-container uagb-block-93000aac\"><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-3a76716b\"><div class=\"plmb plmb-text mce-content clearfix format-classic\">\r\n\t<h2>Patient engagement<\/h2>\n<p>To ensure that this clinical trial is as clinically relevant, practical and effective as possible, a participatory research methodology will be used. This means that researchers will involve people from all over the world who have or are suffering from cancer, and who want their experience to benefit the design and follow-up of Optima-young. These patients have shared their comments with the scientists behind the Optima-young trial. These comments were taken into account, along with those of other stakeholders (patient associations, scientific committees) to improve the Optima-young trial. Throughout the course of the trial, the scientists plan to call on these patients and stakeholders again, to ensure that their comments are taken into account when setting up the trial, conducting and closing it, and disseminating the results.<br \/>\nThis is a collaborative process in which the voices, perspectives and needs of stakeholders can be integrated into the design and conduct of the trial through a process called co-creation.<\/p>\n<\/div>\r\n<\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-9bbac219 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\">\n<div class=\"wp-block-uagb-container uagb-block-d73a2408\"><div class=\"plmb plmb-text mce-content clearfix format-classic\">\r\n\t<h2>Is my local hospital recruiting?<\/h2>\n<p>This international research project will be carried out in some forty hospitals in France and a hundred abroad in Brazil, Peru, Argentina, Belgium, Spain, Italy, Greece, Romania, Poland and Ireland.<br \/>\nIf the <a href=\"https:\/\/www.klineo.fr\/\">Klineo tool<\/a> is available in your country, you can use it to search for clinical trials available in several recruitment centers for which you may be eligible. The Optima-young trial and other trials may be available locally.<\/p>\n<\/div>\r\n<\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-ecb0ace9\"><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-layout-flex uagb-block-8da3950a alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\">\n<div class=\"wp-block-uagb-container uagb-block-99d34d22\"><div class=\"plmb plmb-text mce-content clearfix format-classic\">\r\n\t<h2 style=\"text-align: center\">For further information<\/h2>\n<\/div>\r\n\n\n<div class=\"plmb plmb-cta plmb-cta-center\">\r\n\t\r\n\t<div class=\"cta-wrapper\">\r\n\t\t\t\t<a class=\"cta default\" href=\"#\" target=\"_blank\">\r\n\t\t\tDownload the flyer and information leaflet\t\t<\/a>\r\n\t\t\t\t\t<\/div>\r\n<\/div>\r\n\n\n<div class=\"plmb plmb-text mce-content clearfix format-classic\">\r\n\t<p style=\"text-align: center\">Approved by the Ethics Committees<\/p>\n<\/div>\r\n<\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-3703e03e alignwide uagb-is-root-container\">\n<div class=\"wp-block-uagb-container page-nav-blue uagb-block-b277c911\"><div class=\"plmb plmb-image image-style-none\">\r\n\t\t<figure style=\"width:80px\">\r\n\t\t<div class=\"image-wrapper\" style=\"height:80px\"><img loading=\"lazy\" decoding=\"async\" width=\"1\" height=\"1\" src=\"https:\/\/path-for-young.unicancer.fr\/wp-content\/uploads\/2025\/05\/left-arrow.svg\" class=\"attachment-fhd size-fhd\" alt=\"previous page\" \/><\/div>\t<\/figure>\r\n\t\t<\/div>\r\n\n\n<div class=\"plmb plmb-text mce-content clearfix format-light-margin-title\">\r\n\t<h3 style=\"text-align: left\"><span style=\"font-size: 25px\">Optima-young trial<\/span><\/h3>\n<\/div>\r\n<a class=\"spectra-container-link-overlay\" rel=\"noopener\" href=\"https:\/\/path-for-young.unicancer.fr\/optima-young-trial\/\"> <\/a><\/div>\n\n\n\n<div class=\"wp-block-uagb-container page-nav-green uagb-block-00ee5efe\"><div class=\"plmb plmb-image image-style-none\">\r\n\t\t<figure style=\"width:80px\">\r\n\t\t<div class=\"image-wrapper\" style=\"height:80px\"><img loading=\"lazy\" decoding=\"async\" width=\"1\" height=\"1\" src=\"https:\/\/path-for-young.unicancer.fr\/wp-content\/uploads\/2025\/05\/right-arrow.svg\" class=\"attachment-fhd size-fhd\" alt=\"next page\" \/><\/div>\t<\/figure>\r\n\t\t<\/div>\r\n\n\n<div class=\"plmb plmb-text mce-content clearfix format-light-margin-title\">\r\n\t<h3 style=\"text-align: right\"><span style=\"font-size: 25px;color: #00b8b5\">Patient engagement<br \/>\nand representation<\/span><\/h3>\n<\/div>\r\n<a class=\"spectra-container-link-overlay\" rel=\"noopener\" href=\"https:\/\/path-for-young.unicancer.fr\/patient-engagement-and-representation\/\"> <\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":2219,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","_analytify_skip_tracking":false,"footnotes":""},"class_list":["post-2222","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - 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