[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100386179":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":18,"centralContacts":7,"locations":22,"responsibleParty":35,"collaborators":37,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":7,"enrollmentInfo":50,"targetDuration":7,"studyType":53,"phases":7,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":65,"whyStopped":7,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",null,[9,13,16],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"BEHAVIORAL","Dedicated Discussions on Anticipating preferences of care in the event of Aggravation (DDA)","interview 2",{"type":6,"name":14,"description":15,"armGroupLabels":7,"otherNames":7},"Autonomy Preference Index (API ) questionnaire - Information","part of interview 1",{"type":6,"name":17,"description":15,"armGroupLabels":7,"otherNames":7},"anxiety and depression (HADS) questionnaire",[19],{"name":20,"affiliation":5,"role":21},"Isabelle COLOMBET, MD","PRINCIPAL_INVESTIGATOR",[23],{"facility":24,"status":7,"city":25,"state":7,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":7},"Unité Fonctionnelle de Médecine palliative, Hôpitaux Universitaire Paris Centre - CHU Cochin","Paris","75014","France","FR",{"type":30,"coordinates":31},"Point",[32,33],2.3488,48.85341,{"lat":33,"lon":32},{"type":36,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[38],{"name":39,"class":6},"URC-CIC Paris Descartes Necker Cochin","100386179","do-patients-want-to-engage-in-discussions-dedicated-to-anticipating-dda-their-preferences-of-care-in-the-event-of-worsening-health-status-100386179",false,"NCT04308356","Do Patients Want to Engage in Discussions Dedicated to Anticipating (DDA) Their Preferences of Care in the Event of Worsening Health Status?","\"What if we Talked About it…\" Identification of Cancer Patients Taking up a Proposal for Discussions Dedicated to Anticipating Preferences of Care in the Event of Aggravation (DDA): Prospective Cohort Intervention Study Using a Mixed Methodology","ESOP","Inclusion Criteria:\n\n* Patients 18 years of age or older\n* Followed by oncologists from the medical oncology and pulmonology departments of Cochin Hospital,\n* with advanced stage cancer (solid neoplasm, any location) (locoregional or metastatic),\n* whose objective of care is not curative (in the sense of healing)\n* whose life expectancy is less than 1 year, estimated by the investigating physician, by the standard question, commonly used in the literature, \"would you be surprised if this patient died within the next year?\"\n\nExclusion Criteria:\n\n* Severe psychopathology (generalized anxiety disorder, panic disorder, schizophrenia spectrum disorders, bipolar and related disorders, and major depressive disorders), mentioned in the patient medical record\n* Persistent cognitive disorders, with type of dementia or confusion, mentioned in the patient medical record\n* Patient not fluent in French\n* Eastern Cooperative Oncology Group (ECOG) Performance status = 4\n* A refusal of the patient after proposal and information about the study\n* Patient not affiliated to a social security system","ALL","18 Years",{"count":51,"type":52},71,"ACTUAL","OBSERVATIONAL","Context: In people concerned by serious illness, how to anticipate the aggravation of the disease according to the patient's preferences is a challenging clinical question and an ethical key-issue to improve end-of-life care and quality of dying in France. When end of life decision occurs, many patients can no longer express themselves and advance directives do not seem to be appropriate for many patients despite the current strong incentives to write them, reinforced by the 2016 Claeys Leonetti.\n\nThe \"End-of-Life Discussions\" and \"Advance care planning\" programs developed in the United States have shown a positive impact on the aggressiveness of end-of-life care. The implementation in France of these programs has not yet been consolidated despite a first recommendation for \"Planification des soins futurs\", published by the French Health Authority(HAS). Inspired by the definition given in the later document, investigators propose the acronym DDA, for the Discussions Dedicated to Anticipate wishes and preferences in the event of Aggravation, defined as the dynamic and evolving process of reflection and communication between the patient, his relatives and healthcare professionals, allowing him to address his preferences and wishes regarding his care and treatment\n\nThe objective of this observational study is to characterize, in a population of patients with advanced cancer, the profile of those who take up a proposal for Dedicated Discussions on Anticipating preferences of care in the event of Aggravation (DDA) and who engage in the discussion process. Secondary objectives are to\n\n1. evaluate the aggressiveness of end-of-life care in the group of patients who died 1 year after their inclusion, depending on their engagement in DDA occurs and whether or not their preferences are formalized; and\n2. evaluate the subjective effects of the DDA with the patient and the investigating professionals, through qualitative approach by a clinical psychologist.\n\nMethod: investigators designed a mixed, quantitative and qualitative prospective, monocenter methodology to evaluate how patients take up a proposal of DDA. This proposal consists in 2 interviews: the first one is dedicated to the assessment of the patient's wishes in terms of information and participation in decision-making (API questionnaire) and to the assessment of the degree of anxiety and depression (HADS questionnaire) (E1). The second one is conducted 1 to 4 weeks later and consists in offering and initiating DDA (E2).\n\nQuantitative outcome evaluated will be:\n\n1. the documentation by a physician in the medical record, of patient's care preferences\u002Fvalues\n2. the documentation by the patient of his care preference\u002Fvalues, either by designation of surrogate or by writing advanced directives\n3. the usefulness and necessity of this approach, and the anxiety it generated, as perceived by the patient The qualitative assessment will be based on data collected during E1 and E2, and for 20 patients, during a clinical interview with a psychologist dedicated to collecting the patient's impressions of previous interviews.\n\nThanks to this study investigators expect to gather some data on the desire and feelings of cancer patients to engage in a DDA process and possibly formalize their end-of-life preferences, the impact of DDAs on care pathway indicators and the psychological effect for the patient with severe disease to project himself in advance into aggravation.\n\nThese expected results will provide a better understanding of the process of anticipating end-of-life situations, which is needed to improve quality of care and end-of-life conditions.",[56,57,58],"Neoplasm Metastasis","Locoregional Neoplasm","Advanced Cancer",[60,61,62,63,64],"Prospective monocentric cohort study","Mixed methodology","Dedicated Discussions on Anticipating preferences","Care","Aggravation","COMPLETED","2026-03-09",{"date":68,"type":52},"2026-03-11",{"date":70,"type":52},"2020-06-03",{"date":72,"type":52},"2024-07-07",{"name":5,"class":6},1]