DeCIDE-PC: Community Health Worker Based Intervention to Improve Palliative Care

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05407844
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 310
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 58
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; End Stage Cancer; Malignancy; Advanced Cancer	Other: Community Health Worker (CHW) based palliative care	N/A

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 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 310 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Dissemination and Implementation of a Community Health Worker Intervention for Disparities in Palliative Care: DeCIDE PC
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2027
• Anticipated Study Completion Date: Sep 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard care Standard cancer care
Experimental: Standard care + DeCIDE PC intervention Community health worker support and standard cancer care	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.

Outcome Measures

Primary Outcome Measures

1. Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) [6 months after enrollment]

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

Secondary Outcome Measures

1. Number of participants who completed Advance Directives [6 months after enrollment]

   Advanced care planning

2. Number of participants who utilize hospice care [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 [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) [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

• 18 years old

• English speaking

• Intact cognition and ability to provide informed consent

Caregiver Exclusion Criteria:

• Participants < 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• Johns Hopkins University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Fabian M Johnston, MD, MHS, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT05407844
• Other Study ID Numbers: IRB00283002; 1R01CA252101-01A1
• First Posted: Jun 7, 2022
• Last Update Posted: Jun 10, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Johns Hopkins University: palliative care; community health worker
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jun 10, 2022