[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453908":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":61,"collaborators":64,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":18,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":93,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Alberta Health Services, Calgary","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Palliative and Supportive Care Intervention","EXPERIMENTAL","Participants randomized to the intervention arm will meet (either by phone or Zoom contingent upon participant preference) with a palliative care nurse practitioner or palliative care physician. During the first meeting, pre-transplant\u002FCAR T-cell therapy, content will focus on the provision of information and education, including: a description of palliative and supportive care, symptom management, advance care planning, prognostic and illness understanding and treatment expectations, and coping strategies. All subsequent visits will include, at minimum, these topics. All meetings will be audio-recorded using a handheld audio-recorder; the record feature of Zoom will not be utilized. Participants in the intervention arm will meet with a member of the study team (palliative care nurse practitioner or palliative care physician) one to two times weekly, or more frequently if requested by the patient and\u002For family caregiver, until 3 months post-transplant\u002FCAR T-cell therapy.",[13],"Other: Early palliative and supportive care",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","NO_INTERVENTION","Standard care will involve the usual care that patients undergoing HSCT\u002FCAR T-cell therapy would be expected to receive, including palliative care consultation as needed or upon request. Palliative care interventions beyond what are provided in the study will be tracked in both the intervention and the standard care arms.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Early palliative and supportive care","The intervention itself will be predominantly the provision of education and information. It is possible that patients in the intervention arm may receive treatment recommendations to help manage symptoms.",[9],[25],{"name":26,"affiliation":27,"role":28},"Reanne Booker, PhD(c)","AHS Calgary","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","403-990-1425","Reanne.booker@albertahealthservices.ca",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Tom Baker Cancer Centre","RECRUITING","Calgary","Alberta","Canada","CA",{"type":43,"coordinates":44},"Point",[45,46],-114.08529,51.05011,{"lat":46,"lon":45},[49,52,55,57,59],{"name":50,"role":31,"phone":51,"phoneExt":18,"email":18},"Don Morris, MD PhD","403-521-370",{"name":53,"role":54,"phone":18,"phoneExt":18,"email":18},"Jessica Simon, MD","SUB_INVESTIGATOR",{"name":56,"role":54,"phone":18,"phoneExt":18,"email":18},"Aynharan Sinnarajah, MD",{"name":58,"role":54,"phone":18,"phoneExt":18,"email":18},"Sara Beattie, PhD",{"name":60,"role":28,"phone":18,"phoneExt":18,"email":18},"Reanne Booker, PhD(c) MN",{"type":28,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Reanne Booker","Principal Investigator",[65,67],{"name":66,"class":6},"Alberta Cancer Foundation",{"name":68,"class":6},"University of Victoria","100453908","early-integration-of-palliative-and-supportive-care-in-cellular-therapy-100453908",false,"NCT05190653","Early Integration of Palliative and Supportive Care in Cellular Therapy","Early Integration of Palliative and Supportive Care for Patients and Family Caregivers Undergoing Hematopoietic Stem Cell Transplantation or Chimeric Antigen Receptor T-Cell Therapy: A Prospective Pragmatic Randomized Clinical Trial","PALS_CT","Inclusion Criteria - Patients\n\n* Clinical diagnosis of hematologic malignancy with scheduled hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy\n* Ability to speak, read, and understand English or, be able to complete questionnaires with minimal assistance required from an interpreter\n\nInclusion Criteria - Family Caregivers\n\n* Family caregivers of patients with a clinical diagnosis of hematologic malignancy with scheduled hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy\n* A spouse, relative, or friend, identified by the patient, who either lives with the patient or has in-person contact with the patient at least twice per week. Only one family CG per patient will be asked to participate.\n* Ability to speak, read, and understand English or willing to complete questionnaires with minimal assistance required from an interpreter\n\nExclusion Criteria - Patients\n\n* Patients undergoing HSCT for a non-malignant hematologic condition\n* Inability to provide informed consent\n\nExclusion Criterion - Family Caregivers\n\n\\* Inability to provide informed consent","ALL","18 Years",{"count":80,"type":81},152,"ESTIMATED","INTERVENTIONAL",[84],"NA","Research has shown that early palliative care in cancer care is associated with improved symptom management, better prognostic understanding, improved quality of life for patients and family caregivers, and even improved survival. Yet, in spite of the proven benefits of integration of palliative care in oncology, it has been well established that patients with hematologic malignancies and those undergoing cellular therapy (hematopoietic stem cell transplantation (HSCT) and chimeric antigen receptor (CAR) T-cell therapy) do not routinely receive palliative care. Most of the published research on the early integration of palliative care in oncology describes studies that have involved patients with solid tumours. To date, only one randomized trial examining the impact of integrated palliative care among patients undergoing HSCT has been published and there have been no studies examining the impact of integrated palliative care for patients undergoing CAR T-cell therapy. The American Society of Clinical Oncology recommends early palliative care for patients with advanced cancers or for those with high symptom burden. Patients with blood cancers experience high symptom burden and in the last 30 days of life, compared to patients with solid tumours, patients with blood cancers are more likely to die in hospital, have more intensive care unit admissions, have prolonged hospitalizations (\\>14 days), and pass away in an acute care facility. There is an urgent need to proactively address suffering throughout cellular therapy trajectories, even before treatment starts, so that patients and caregivers are not inevitably waiting for symptoms to arise before they can be addressed and to optimize quality of life for patients undergoing transplant as well as their family caregivers.\n\nPALS\\_CT will compare early palliative care to standard care for patients and their family caregivers undergoing HSCT or CAR T-cell therapy for blood cancers.",[87,88,89,90,91,92],"Leukemia","Lymphoma","Multiple Myeloma","Blood Cancer","Stem Cell Transplant Complications","Chimeric Antigen Receptor T-cell Therapy",[94,95,96,97,98],"palliative care","supportive care","quality of life","symptom burden","hematologic malignancies","2024-07-30",{"date":101,"type":102},"2024-07-31","ACTUAL",{"date":104,"type":102},"2022-04-08",{"date":106,"type":81},"2025-12",{"name":5,"class":6},1]