Clinical trial NCT05407844: Community Health Worker Based Intervention to Improve Palliative Care
Official title: Community Health Worker Based Intervention to Improve Palliative Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
End Stage Cancer
Malignancy
Advanced Cancer
Keywords: palliative care
community health worker
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-06-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of participants who completed Advance Directives
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score
timeFrame: 6 months after enrollment
measure: Number of participants who utilize hospice care
timeFrame: 6 months after enrollment
measure: Goals of care as assessed by Quality of communication (QOC) scale
timeFrame: 6 months after enrollment
measure: Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS)
timeFrame: 6 months after enrollment
measure: Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 6 months after enrollment
measure: Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L)
timeFrame: 6 months after enrollment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Salisbury
country: United States
facility: TidalHealth Peninsula Regional, Inc.
state: Maryland
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Fabian M Johnston, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Aarti Mathur, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.