Community Health Worker Based Intervention to Improve Palliative Care

Cancer Clinical Trial

Official title:

Community Health Worker Based Intervention to Improve Palliative Care

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05407844
• Other study ID #: IRB00283002
• Secondary ID: 1R01CA252101-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: November 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 310
• Est. completion date: September 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Cancer
• End Stage Cancer
• Malignancy
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who completed Advance Directives	Advanced care planning	6 months after enrollment
Secondary	Functional Assessment of Chronic Illness Therapy-Palliative Subscale (FACIT-PAL) score	Quality of Life; Score range: 0-184 [per scoring document, for total score] Higher scores signify better quality of life	6 months after enrollment
Secondary	Number of participants who utilize hospice care	Hospice care utilization within 14 days of death (Yes/No)	6 months after enrollment
Secondary	Goals of care as assessed by Quality of communication (QOC) scale	Goals of Care; Score range: 0-10 [scored 0-10 for each of 19 components] Higher scores signify: higher quality communication with physician	6 months after enrollment
Secondary	Symptom Intensity as assessed by the Edmonton Symptom Assessment Score (ESAS)	Symptom; Score range: 0-10 [scored 0-10 for 10 components] Higher scores signify: higher intensity of cancer symptoms (worse symptoms)	6 months after enrollment
Secondary	Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)	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 months after enrollment