Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05407844

Community Health Worker Based Intervention to Improve Palliative Care

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Cancer Advanced Cancer End Stage Cancer Malignancy Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of participants who completed Advance Directives

    Time frame: 6 months after enrollment

    Advanced care planning

Secondary outcomes

  1. Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score

    Time frame: 6 months after enrollment

    Quality of Life; Score range: 0-184 [per scoring document, for total score] Higher scores signify better quality of life

  2. Number of participants who utilize hospice care

    Time frame: 6 months after enrollment

    Hospice care utilization within 14 days of death (Yes/No)

  3. Goals of care as assessed by Quality of communication (QOC) scale

    Time frame: 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

  4. Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS)

    Time frame: 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)

  5. Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 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.

  6. Quality of life assessed by the 5-Level EuroQol 5-Dimensional (EQ-5D-5L)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: DeCIDE PC

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 7, 2022
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.