Community Health Worker Based Intervention to Improve Palliative Care
- Conditions
- Advanced CancerCancerMalignancyEnd Stage Cancer
- Interventions
- Other: Community Health Worker (CHW) based palliative care
- Registration Number
- NCT05407844
- Lead Sponsor
- Johns Hopkins University
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 310
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care + DeCIDE PC intervention Community Health Worker (CHW) based palliative care Community health worker support and standard cancer care
- Primary Outcome Measures
Name Time Method Number of participants who completed Advance Directives 6 months after enrollment Advanced care planning
- Secondary Outcome Measures
Name Time Method Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score 6 months after enrollment Quality 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 care 6 months after enrollment Hospice care utilization within 14 days of death (Yes/No)
Goals of care as assessed by Quality of communication (QOC) scale 6 months after enrollment Goals 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 enrollment Symptom; 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 enrollment 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.
Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L) 6 months after enrollment 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.
Trial Locations
- Locations (4)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
TidalHealth Peninsula Regional, Inc.
🇺🇸Salisbury, Maryland, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States