CHW Support for Advanced Cancer Care

(DeCIDE-PC Trial)

Enrolling by invitation at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether support from community health workers (CHWs) can improve the quality of life for African American patients with advanced cancer. Researchers aim to determine if this additional support, including CHW-based palliative care, makes a difference compared to standard cancer care alone. African American patients with advanced cancer who are not currently receiving palliative care might be suitable candidates.

As an unphased trial, this study provides a unique opportunity for patients to contribute to research that could enhance cancer care support systems.

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 prior data suggests that community health worker support is safe for palliative care in advanced cancer patients?

Research has shown that community health workers (CHWs) in palliative care are safe and beneficial. Studies indicate that CHWs enhance patients' quality of life and reduce hospital visits for those with advanced cancer. Other research suggests that palliative care involving CHWs receives positive feedback. Patients often experience improved symptom control and greater satisfaction with their care. No major negative effects have been linked to this type of care. Overall, CHWs appear to be a safe and supportive addition to standard cancer care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHW-based palliative care because it introduces a personalized approach to supporting patients with advanced cancer. Unlike standard cancer care, which primarily focuses on medical treatment, this method integrates community health workers to provide emotional and practical support, aiming to improve quality of life. This approach is distinct because it emphasizes holistic care, addressing not just physical symptoms but also emotional and social well-being, potentially leading to better overall outcomes for patients.

What evidence suggests that CHW support is effective for improving palliative care outcomes in advanced cancer?

Research has shown that involving community health workers (CHWs) in palliative care can significantly benefit patients with advanced cancer. In this trial, one group will receive standard cancer care, while another will receive standard care plus the DeCIDE PC intervention, which includes CHW support. Specifically, one study found that patients with CHW support had a 62% lower risk of serious health problems compared to those without it. These programs not only enhance patient care but also improve conditions for caregivers. Another small study found that CHW assistance facilitated access to palliative care for African American patients. Overall, CHW support is a cost-effective way to enhance the quality of life for cancer patients. ^{3 6 7 8 9}

Who Is on the Research Team?

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

Principal Investigator

Johns Hopkins School of Medicine

Aarti Mathur, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10517647/

The effectiveness of community-based palliative care ... There is evidence that community-based palliative care programmes can improve patient outcomes and caregiver experiences cost-effectively.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8257996/

Can Community Health Workers Increase Palliative Care ... The aim of this pilot study was to investigate the feasibility of a CHW intervention to improve PC utilization by African American patients with advanced cancer ...

3. clinicaltrial.be clinicaltrial.be/en/details/175690?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Community Health Worker Based Intervention to Improve ... The objectives of this study are to establish the effectiveness of a CHW-based palliative care intervention and develop generalizable knowledge ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2793859

Effect of a Community Health Worker Intervention on Acute ... In this randomized clinical trial that included 128 adults with cancer, patients in the community health worker–led intervention had a 62% decreased risk of ...

5. bmcpalliatcare.biomedcentral.com bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-023-01250-0

a study protocol for a hybrid type 1 randomized controlled trial DeCIDE PC is an integrated community health worker (CHW) palliative care intervention that uses community health workers (CHWs) as care team members.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6735317/

Effects of a Population Health Community-Based Palliative ... We evaluated utilization and cost outcomes of a standardized, population health community-based palliative care program provided by nurses and social workers.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10474632/

Comparison of home-based palliative care delivered by ... Research studies demonstrate that palliative care can improve patient outcomes such as quality of life, symptom burden and patient ...

8. capc.org capc.org/blog/release-of-community-health-worker-chw-policy-brief/

Release of Community Health Worker (CHW) Policy Brief The brief provides an overview of emerging policies that aim to support and broaden the reach of the work of CHWs, including but not limited to ...

9. cancer.gov cancer.gov/news-events/cancer-currents-blog/2022/advanced-cancer-community-health-workers

Community Health Workers Aid People with Advanced ... For people with advanced cancer, regular home visits from community health workers reduced hospital trips and increased use of palliative care, among other ...