Skip to content

Community Health Worker Based Intervention to Improve Palliative Care

Community Health Worker Based Intervention to Improve Palliative Care

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05407844
Acronym
DeCIDE PC
Enrollment
160
Registered
2022-06-07
Start date
2023-11-02
Completion date
2027-09-01
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer, Cancer, End Stage Cancer, Malignancy

Keywords

palliative care, community health worker

Brief summary

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

OTHERCommunity 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.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who completed Advance Directives6 months after enrollmentAdvanced care planning

Secondary

MeasureTime frameDescription
Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score6 months after enrollmentQuality of Life; Score range: 0-184 \[per scoring document, for total score\] Higher scores signify better quality of life
Number of participants who utilize hospice care6 months after enrollmentHospice care utilization within 14 days of death (Yes/No)
Goals of care as assessed by Quality of communication (QOC) scale6 months after enrollmentGoals of Care; Score range: 0-10 \[scored 0-10 for each of 19 components\] Higher scores signify: higher quality communication with physician
Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS)6 months after enrollmentSymptom; Score range: 0-10 \[scored 0-10 for 10 components\] Higher scores signify: higher intensity of cancer symptoms (worse symptoms)
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)6 months after enrollmentSymptom; The score is the sum of the 20 questions. Possible range is 0-60. A score of 16 points or more is considered depressed.
Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L)6 months after enrollmentit 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORFabian M Johnston, MD, MHS

Atrium Health Wake Forest Baptist

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026