[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05407844":3,"trial-entities:NCT05407844":131,"trial-summary:NCT05407844":135},{"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":22,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":43,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":77,"locations":80,"central_contacts":113,"overall_officials":114,"references":118,"see_also_links":130},"NCT05407844","IRB00119097","Community Health Worker Based Intervention to Improve Palliative Care","ENROLLING_BY_INVITATION","2027-09-01","2026-07","2026-07-23","2023-11-02","Wake Forest University Health Sciences","OTHER",true,"The study aims to find out if community health worker (CHW) support will improve palliative care outcomes in African American patients with advanced cancer, by comparing the quality of life of patients who are receiving standard care to those whose standard care is supplemented with CHW support.","This research is being done to establish the effectiveness of a Community Health Worker based palliative care intervention among African American patients with advanced solid organ malignancies and their care givers.\n\nThe investigators' long-term goal is to reduce the research-to-practice gap in utilization of evidence-based palliative care (PC) in African Americans with advanced cancer. The objectives of this study are to establish the effectiveness of a CHW-based palliative care intervention and develop generalizable knowledge on how contextual factors influence implementation.",[18,19,20,21],"Cancer","End Stage Cancer","Malignancy","Advanced Cancer",[23,24],"palliative care","community health worker","INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},160,"ESTIMATED",[33],{"type":13,"name":34,"description":35,"armGroupLabels":36},"Community Health Worker (CHW) based palliative care","Those in the intervention group will receive support from a dedicated CHW trained in motivational interviewing, components of palliative care communication, and social determinants of health.",[37],"Standard care + DeCIDE PC intervention",[39],{"measure":40,"description":41,"timeFrame":42},"Number of participants who completed Advance Directives","Advanced care planning","6 months after enrollment",[44,47,50,53,56,59],{"measure":45,"description":46,"timeFrame":42},"Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score","Quality of Life; Score range: 0-184 \\[per scoring document, for total score\\] Higher scores signify better quality of life",{"measure":48,"description":49,"timeFrame":42},"Number of participants who utilize hospice care","Hospice care utilization within 14 days of death (Yes\u002FNo)",{"measure":51,"description":52,"timeFrame":42},"Goals of care as assessed by Quality of communication (QOC) scale","Goals of Care; Score range: 0-10 \\[scored 0-10 for each of 19 components\\] Higher scores signify: higher quality communication with physician",{"measure":54,"description":55,"timeFrame":42},"Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS)","Symptom; Score range: 0-10 \\[scored 0-10 for 10 components\\] Higher scores signify: higher intensity of cancer symptoms (worse symptoms)",{"measure":57,"description":58,"timeFrame":42},"Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)","Symptom; The score is the sum of the 20 questions. Possible range is 0-60. A score of 16 points or more is considered depressed.",{"measure":60,"description":61,"timeFrame":42},"Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L)","it assesses five dimensions (mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression) and a visual analogue scale (VAS). Each dimension has five levels ranging from 1 (no problem) to 5 (extreme problem). Score range 0 to 100, higher score indicates better quality of life.","ALL","18 Years",null,false,{"inclusion":67,"exclusion":73,"raw_text":76},[68,69,70,71,72,70,71],"Self-identified African American patients with advanced (AJCC stage III or IV) solid organ malignancy","\\>=18 years old","English speaking","Intact cognition and ability to provide informed consent","Adult (\\>=18 years old) caregivers providing informal (unpaid) care to an eligible African American cancer patient (related or unrelated)",[74,75,74],"Participants \\\u003C 18 years of age","Participants who are already receiving palliative care services","Patient Inclusion Criteria:\n\n* Self-identified African American patients with advanced (AJCC stage III or IV) solid organ malignancy\n* \\>=18 years old\n* English speaking\n* Intact cognition and ability to provide informed consent\n\nPatient Exclusion Criteria:\n\n* Participants \\\u003C 18 years of age\n* Participants who are already receiving palliative care services\n\nCaregiver Inclusion Criteria:\n\n* Adult (\\>=18 years old) caregivers providing informal (unpaid) care to an eligible African American cancer patient (related or unrelated)\n* English speaking\n* Intact cognition and ability to provide informed consent\n\nCaregiver Exclusion Criteria:\n\n* Participants \\\u003C 18 years of age",[78,79],"ADULT","OLDER_ADULT",[81,90,98,105],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"University of Alabama at Birmingham","Birmingham","Alabama","35233","United States",{"lat":88,"lon":89},33.52066,-86.80249,{"facility":91,"city":92,"state":93,"zip":94,"country":86,"geoPoint":95},"Johns Hopkins University School of Medicine","Baltimore","Maryland","21205",{"lat":96,"lon":97},39.29038,-76.61219,{"facility":99,"city":100,"state":93,"zip":101,"country":86,"geoPoint":102},"TidalHealth Peninsula Regional, Inc.","Salisbury","21801",{"lat":103,"lon":104},38.36067,-75.59937,{"facility":106,"city":107,"state":108,"zip":109,"country":86,"geoPoint":110},"Atrium Health Wake Forest Baptist","Winston-Salem","North Carolina","27157",{"lat":111,"lon":112},36.09986,-80.24422,[],[115],{"name":116,"affiliation":106,"role":117},"Fabian M Johnston, MD, MHS","PRINCIPAL_INVESTIGATOR",[119,123,127],{"pmid":120,"type":121,"citation":122},"30388060","BACKGROUND","Johnston FM, Neiman JH, Parmley LE, Conca-Cheng A, Freund KM, Concannon TW, Smith TJ, Cooper LA. Stakeholder Perspectives on the Use of Community Health Workers To Improve Palliative Care Use by African Americans with Cancer. J Palliat Med. 2019 Mar;22(3):302-306. doi: 10.1089\u002Fjpm.2018.0366. Epub 2018 Nov 2.",{"pmid":124,"type":125,"citation":126},"41193212","DERIVED","Monton O, Drabo EF, Masroor T, Fuller S, Woods AP, Siddiqi A, Malone TB, Johnston FM. Economic evaluation of a hybrid type 1 effectiveness-implementation trial comparing a community health worker palliative care intervention to enhanced standard of care in African American patients across four cancer centres in the USA: a study protocol. BMJ Open. 2025 Nov 4;15(11):e096402. doi: 10.1136\u002Fbmjopen-2024-096402.",{"pmid":128,"type":125,"citation":129},"37718442","Siddiqi A, Monton O, Woods A, Masroor T, Fuller S, Owczarzak J, Yenokyan G, Cooper LA, Freund KM, Smith TJ, Kutner JS, Colborn KL, Joyner R, Elk R, Johnston FM. Dissemination and Implementation of a Community Health Worker Intervention for Disparities in Palliative Care (DeCIDE PC): a study protocol for a hybrid type 1 randomized controlled trial. BMC Palliat Care. 2023 Sep 18;22(1):139. doi: 10.1186\u002Fs12904-023-01250-0.",[],{"nct_id":4,"conditions":132,"biomarkers":134},[133],"Solid Neoplasm",[],{"nct_id":4,"found":65,"summary":64,"prompt_version":64}]