[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100379776":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":36,"locations":45,"responsibleParty":113,"collaborators":115,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":11,"enrollmentInfo":132,"targetDuration":11,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":11,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Canadian Cancer Trials Group","NETWORK",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Other: Usual Care","EXPERIMENTAL",null,[9],{"label":14,"type":10,"description":15,"interventionNames":16},"Behavioral: Usual Care + EASE Intervention-psy","EASE Intervention = EASE-psy + EASE-phys",[17],"Behavioral: EASE-psy",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"OTHER","Usual Care","The usual care group will receive usual care of their acute leukemia at their centre but no formal psychological or palliative care intervention as part of this trial",[9],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"BEHAVIORAL","EASE-psy","All patients randomized to EASE will receive tailored supportive psychotherapy over the initial 8 weeks following the diagnosis of acute leukemia. The psychotherapy will be delivered by trained therapists and combines elements of relational support, affect regulation, and trauma-informed cognitive behavioural therapy (CBT).\n\n-EASE-phys: All patients randomized to EASE will receive weekly symptom screening during the initial inpatient treatment period (typically 4 weeks) with triggered referral to early palliative care (symptom control) to help manage moderate to severe physical symptoms based on a philosophy of multidisciplinary care and comprehensive assessment of symptoms.",[14],[30,34],{"name":31,"affiliation":32,"role":33},"Gary Rodin","Princess Margaret Hospital, Canada","STUDY_CHAIR",{"name":35,"affiliation":32,"role":33},"Camilla Zimmerman",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":11,"email":41},"Harriet Richardson","CONTACT","613-533-6430","hrichardson@ctg.queensu.ca",{"name":43,"role":39,"phone":40,"phoneExt":11,"email":44},"Lois Shepherd","lshepherd@ctg.queensu.ca",[46,63,77,90,104],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Juravinski Cancer Centre at Hamilton Health Sciences","RECRUITING","Hamilton","Ontario","L8V 5C2","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-79.84963,43.25011,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":11,"phoneExt":11,"email":11},"Alejandro Garcia-Horton",{"facility":64,"status":48,"city":65,"state":50,"zip":66,"country":52,"countryCode":53,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Kingston Health Sciences Centre","Kingston","K7L 2V7",{"type":55,"coordinates":68},[69,70],-76.48098,44.22976,{"lat":70,"lon":69},[73],{"name":74,"role":39,"phone":75,"phoneExt":76,"email":11},"Annette Hay","613 533-6430","77094",{"facility":78,"status":48,"city":79,"state":50,"zip":80,"country":52,"countryCode":53,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Ottawa Hospital Research Institute","Ottawa","K1H 8L6",{"type":55,"coordinates":82},[83,84],-75.69812,45.41117,{"lat":84,"lon":83},[87],{"name":88,"role":39,"phone":89,"phoneExt":11,"email":11},"Pierre Villeneuve","613",{"facility":91,"status":48,"city":92,"state":50,"zip":93,"country":52,"countryCode":53,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Odette Cancer Centre","Toronto","M4N 3M5",{"type":55,"coordinates":95},[96,97],-79.39864,43.70643,{"lat":97,"lon":96},[100],{"name":101,"role":39,"phone":102,"phoneExt":103,"email":11},"Lee Mozessohn","416 480-5000","5847",{"facility":105,"status":48,"city":92,"state":50,"zip":106,"country":52,"countryCode":53,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"University Health Network","M5G 2M9",{"type":55,"coordinates":108},[96,97],{"lat":97,"lon":96},[111],{"name":31,"role":39,"phone":112,"phoneExt":11,"email":11},"416 946-4504",{"type":114,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[116,118,121],{"name":117,"class":20},"Canadian Cancer Society (CCS)",{"name":119,"class":120},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":32,"class":20},"100379776","emotion-and-symptom-focused-engagement-trial-for-individuals-with-acute-leukemia-100379776",false,"NCT04224974","Emotion and Symptom-Focused Engagement Trial for Individuals With Acute Leukemia","Emotion and Symptom-Focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals With Acute Leukemia","EASE","Inclusion Criteria:\n\n* Newly diagnosed AL (acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) chronic myelogenous leukemia (CML) in blast crisis; T-cell leukemia lymphoma (TLL), and AL of ambiguous lineage) and is recruited up to 1 week prior to hospital admission or within 2 weeks of hospital admission. For patients diagnosed with a mixed phenotype AL, the dominant sub-type must be identified for stratification purposes.\n* Receiving or expected to receive induction therapy with curative intent at the time of recruitment.\n* Age ≥ 18 years.\n* Ability to pass the cognitive screening test at the time of recruitment (Short Orientation-Memory-Concentration Test (SOMC) score ≥ 20), unless deemed suitable at the CRA's discretion (e.g. in extenuating circumstances such as interruptions during the administration of the measure or when patients report a learning disability that can influence the results).\n* Patient is fluent in English and is able (i.e. sufficiently literate and competent) and willing to complete the baseline questionnaires in English. Ability but unwillingness to complete the baseline questionnaires will make the patient ineligible.\n\nExclusion Criteria:\n\n* Major communication difficulties at the time of recruitment, as assessed by the research team (e.g. severe hearing impairment or inability to speak).\n* Receiving on-site (in hospital) psychological\u002Fpsychiatric counseling at the time of recruitment.\n* Receiving on-site (in hospital) palliative care services at the time of recruitment.\n* A diagnosis of acute promyelocytic leukemia.","ALL","18 Years",{"count":133,"type":134},266,"ESTIMATED","INTERVENTIONAL",[137],"NA","The purpose of this study is to find out whether a novel manualized intervention, called Emotion and Symptom-focused Engagement (EASE), that combines psychological support with symptom screening plus triggered referral to early palliative care for symptom control, reduces psychological distress and physical symptom burden in individuals newly diagnosed with acute leukemia. To do this, half of the participants in this study will receive the usual care offered to patients with acute leukemia and half of the participants will receive usual care plus the EASE intervention.",[140],"Acute Leukemia","2026-03-24",{"date":143,"type":144},"2026-03-27","ACTUAL",{"date":146,"type":144},"2022-01-06",{"date":148,"type":134},"2027-06-30",{"name":5,"class":6},5]