[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06676852":3,"trial-entities:NCT06676852":86,"trial-summary:NCT06676852":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":44,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":14,"eligibility_criteria":52,"std_ages":61,"locations":64,"central_contacts":81,"overall_officials":83,"references":84,"see_also_links":85},"NCT06676852","24-322","Feasibility and Acceptability of Primary Palliative Care Intervention in Patients Undergoing Hematopoietic Stem Cell Transplantation","RECRUITING","2027-03-30","2026-04","2026-04-24","2026-01-05","Massachusetts General Hospital","OTHER",false,"Primary PC - or training HCT clinicians to deliver PC domains as part of routine practice - is an alternative model of supportive care. We have developed Sentinel, a primary PC intervention for HCT clinicians and patients. This study will assess Sentinel's feasibility and acceptability.","Patients hospitalized for hematopoietic cell transplantation (HCT) experience physical and psychological symptoms that lead to a deterioration in quality of life (QOL). Integrating specialty palliative care (PC) reduces physical and psychological symptom burden and improves QOL during HCT hospitalization. However, specialty PC remains unavailable and underused at many HCT centers. Primary PC - or training HCT clinicians to deliver PC domains as part of routine practice - is an alternative model of supportive care. We have developed Sentinel, a primary PC intervention for HCT clinicians and patients. We will train HCT clinicians to deliver PC to patients before and during HCT hospitalization. This study will assess Sentinel's feasibility and acceptability.",[18,19],"Hematopoietic Cell Transplant","Hematologic Malignancy",[21,22,23,24],"palliative care","supportive care","primary palliative care","hematopoietic cell transplantation","INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},40,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Primary palliative care","Enrolled patient participants will receive Sentinel prior to and during their hospitalization for HCT. Prior to HCT, a transplant clinician (nurse practitioner - NP) will conduct a focused PC visit to build rapport, manage expectations regarding HCT, review anticipated symptoms, and discuss illness coping strategies. During the HCT hospitalization, HCT physicians and advanced practice providers will incorporate PC domains into their routine care of patients undergoing HCT.",[38],"Sentinel, primary palliative care intervention",[40],{"measure":41,"description":42,"timeFrame":43},"Feasibility","We will assess feasibility of Sentinel based on the proportion of eligible patients who enroll and the proportion of enrolled patients retained. Sentinel will be deemed feasible if at least 60% of eligible patients are enrolled in the study and patient retention through study procedures is at least 80%, commonly utilized metrics in PC trials","Up to Day 90",[45],{"measure":46,"description":47,"timeFrame":48},"Acceptability","The intervention will be acceptable for patients if at least 80% of patients report intervention satisfaction (Client Satisfaction Questionnaire mean greater than or equal 3.0\u002F4.0)","At Day 30","ALL","18 Years",null,{"inclusion":53,"exclusion":56,"raw_text":60},[54,55],"Age 18 years or older","Undergoing autologous or allogeneic HCT at MGH",[57,58,59],"Prior receipt of inpatient specialty palliative care on two prior admissions in the past 6 months.","Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or ability to participate in study procedures","Inability to comprehend English as this is a preliminary\u002Fpilot study","Inclusion Criteria:\n\n* Age 18 years or older\n* Undergoing autologous or allogeneic HCT at MGH\n\nExclusion Criteria:\n\n* Prior receipt of inpatient specialty palliative care on two prior admissions in the past 6 months.\n* Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or ability to participate in study procedures\n* Inability to comprehend English as this is a preliminary\u002Fpilot study",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":12,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":78},"Boston","Massachusetts","02152","United States",[71,76],{"name":72,"role":73,"phone":74,"email":75},"Richard A Newcomb, MD","CONTACT","617-996-7584","richard.newcomb@mgh.harvard.edu",{"name":72,"role":77},"PRINCIPAL_INVESTIGATOR",{"lat":79,"lon":80},42.35843,-71.05977,[82],{"name":72,"role":73,"phone":74,"email":75},[],[],[],{"nct_id":4,"conditions":87,"biomarkers":90},[88,89],"Hematopoietic Cell Transplantation","Malignant neoplasm of lymphoid, hematopoietic and\u002For related tissue",[],{"nct_id":4,"found":92,"summary":93,"prompt_version":103},true,{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an interventional study with a planned enrollment of 40 participants. It is designed to assess the feasibility and acceptability of the Sentinel intervention.","completed","Feasibility and Acceptability of Sentinel for Hematopoietic Stem Cell Transplant Patients","This study is testing a new approach called Sentinel, which is a primary palliative care (PC) intervention. Palliative care focuses on providing comfort and support to improve your quality of life. Sentinel aims to train transplant clinicians (like nurse practitioners) to deliver PC to patients undergoing hematopoietic stem cell transplantation (HCT) for blood cancers. The goal is to see if Sentinel is practical to use and if patients find it helpful. You might be able to join if you are 18 or older and are having an HCT at MGH. The study will look at how practical Sentinel is for up to 90 days. The current recruitment status is unclear.","Feasibility will be measured up to Day 90 after the intervention.",110,"Enrolled participants will receive the Sentinel intervention before and during their hospitalization for HCT. A transplant clinician will conduct a focused PC visit prior to HCT.","Not stated in the trial record.",[35],"v2"]