CHW Support for Advanced Cancer Care

(DeCIDE-PC Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Under 18, Receiving palliative care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

160 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Community Health Worker (CHW) based palliative care for advanced cancer care?

Research shows that Community Health Workers (CHWs) can effectively extend palliative care services, especially in areas with limited medical personnel, by providing physical and spiritual comfort, educating families, and supporting medication management. Studies in India and South Africa highlight the feasibility and positive impact of CHWs in delivering home-based palliative care, improving access and outcomes for patients with advanced cancer. ^{1 2 3 4 5}

Is the use of Community Health Workers (CHWs) in palliative care safe for humans?

The research does not specifically address safety concerns, but it shows that CHWs have been effectively trained and utilized in palliative care settings in various countries, suggesting that their involvement is generally considered safe. ^{1 2 3 6 7}

How does CHW support for advanced cancer care differ from other treatments?

This treatment is unique because it involves community health workers (CHWs) who provide palliative care support directly within patients' communities, especially in low-resource settings. Unlike traditional treatments that rely heavily on hospital-based care, this approach focuses on home-based care, offering physical and spiritual comfort, education, and medication management support. ^{1 2 4 8 9}

What is the purpose of this trial?

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.

Research Team

Aarti Mathur, MD

Principal Investigator

Johns Hopkins University

Fabian M Johnston, M.D., M.H.S., F.A.C.S

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for self-identified African American adults over 18 with advanced solid organ cancer (stage III or IV), who speak English and can consent. It's not specified who cannot join, but typically those with cognitive issues or other exclusions may be ineligible.

Inclusion Criteria

I understand information and can make decisions about my health care.

English speaking

I am African American with advanced stage cancer.

Exclusion Criteria

I am currently receiving palliative care.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard cancer care with or without Community Health Worker support

6 months

Follow-up

Participants are monitored for quality of life, symptom intensity, depression, and other outcomes

6 months

Treatment Details

Interventions

• Community Health Worker (CHW) based palliative care

Trial Overview The study tests if adding community health worker support to standard care improves the quality of life for patients compared to those only receiving standard care without this extra support.

Participant Groups

Group I: Standard care + DeCIDE PC intervention Experimental Treatment 1 Intervention

Community health worker support and standard cancer care

Group II: Standard care Active Control 1 Intervention

Standard cancer care

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Community health workers in palliative care provision in low-income and middle-income countries: a systematic scoping review of the literature. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A Qualitative Evaluation of a Home-based Palliative Care Program Utilizing Community Health Workers in India. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Palliative Care Curriculum and Training Plan for community health workers. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Palliative Care Practices in a Rural Community: Cultural Context and the Role of Community Health Worker. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Dissemination and Implementation of a Community Health Worker Intervention for Disparities in Palliative Care (DeCIDE PC): a study protocol for a hybrid type 1 randomized controlled trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Technology and rehabilitation training for community health workers: Strengthening health systems in Malawi. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Community Health Workers' Palliative Care Learning Needs and Training: Results from a Partnership between a US University and a Rural Community Organization in Mpumalanga Province, South Africa. [2018]

8. South Africa pubmed.ncbi.nlm.nih.gov

The role of community health workers in palliative care in a rural subdistrict in South Africa. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Community outreach to patients with AIDS at the end of life in the inner city: reflections from the trenches. [2019]