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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA252101-01A1 | U.S. NIH Grant/Contract | View source | |
| 1R01MD016935-01 | U.S. NIH Grant/Contract | View source | |
| IRB00283002 | Other Identifier | Johns Hopkins (old IRB #) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | No Intervention | Standard cancer care | |
| Standard care + DeCIDE PC intervention | Experimental | Community health worker support and standard cancer care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Health Worker (CHW) based palliative care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who completed Advance Directives | Advanced care planning | 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months after enrollment |
| Number of participants who utilize hospice care |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabian M Johnston, MD, MHS | Atrium Health Wake Forest Baptist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Johns Hopkins University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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/jpm.2018.0366. Epub 2018 Nov 2. | |
| 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/bmjopen-2024-096402. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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Hospice care utilization within 14 days of death (Yes/No) |
| 6 months after enrollment |
| 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 | 6 months after enrollment |
| 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) | 6 months after enrollment |
| 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. | 6 months after enrollment |
| Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L) | it assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) 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. | 6 months after enrollment |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| TidalHealth Peninsula Regional, Inc. | Salisbury | Maryland | 21801 | United States |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
| 37718442 | Derived | 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/s12904-023-01250-0. |