Community Health Worker Based Intervention to Improve Palliative Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Community Health Worker (CHW) based palliative care.
- Who it may be relevant to
- Registry conditions: Cancer, End Stage Cancer, Malignancy, Advanced Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other 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.
Primary outcome measures
- Number of participants who completed Advance Directives [Time frame: 6 months after enrollment]
Secondary outcome measures (6)
- Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score [Time frame: 6 months after enrollment]
- Number of participants who utilize hospice care [Time frame: 6 months after enrollment]
- Goals of care as assessed by Quality of communication (QOC) scale [Time frame: 6 months after enrollment]
- Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS) [Time frame: 6 months after enrollment]
- Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D) [Time frame: 6 months after enrollment]
- Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L) [Time frame: 6 months after enrollment]
Eligibility criteria
Patient Inclusion Criteria:
- 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
Patient Exclusion Criteria:
- Participants < 18 years of age
- Participants who are already receiving palliative care services
Caregiver Inclusion Criteria:
- Adult (>=18 years old) caregivers providing informal (unpaid) care to an eligible African American cancer patient (related or unrelated)
- English speaking
- Intact cognition and ability to provide informed consent
Caregiver Exclusion Criteria:
- Participants < 18 years of age
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 4 centers
- University of Alabama at Birmingham — Birmingham
- Johns Hopkins University School of Medicine — Baltimore
- TidalHealth Peninsula Regional, Inc. — Salisbury
- Atrium Health Wake Forest Baptist — Winston-Salem
Publications
- 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. PMID 30388060
- 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-20 PMID 41193212
- 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: 10.1 PMID 37718442
Identifiers
NCT: NCT05407844 · IRB00119097 · 1R01CA252101-01A1 · 1R01MD016935-01 · IRB00283002