Community Health Support for Head and Neck Cancer

(ENRICH-HNC Trial)

Not yet recruiting at 1 trial location

Overseen By David Schwartz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Tennessee

Disqualifiers: Prior oncology care, Hospice, Incarcerated, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to provide quicker access to treatment for people with head and neck cancer after an emergency department visit. The program includes support from trained specialists, known as Community Health Support Specialists (CHSS), who address issues such as transportation, insurance, or communication problems. Individuals who have recently visited the emergency department with a new or suspected head or neck cancer and live near certain hospitals may be suitable candidates. The goal is to reduce delays in starting cancer treatment and determine if this support makes a difference. Results will guide future studies to enhance care access for these patients. As an unphased trial, this study offers a unique opportunity to contribute to improving healthcare access for future patients.

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 focuses on providing support to improve access to timely care for head and neck cancer patients.

What prior data suggests that this community-based navigation program is safe for head and neck cancer patients?

Research has shown that community health support, such as assistance from Community Health Support Specialists (CHSS), is generally safe and well-received. In similar programs, these specialists guide individuals in accessing care and addressing issues like transportation or insurance. This approach has been implemented elsewhere without major safety concerns. As the CHSS program emphasizes support rather than medical treatment, it is considered safe for participants. Similar past studies have reported no negative effects, indicating that this type of support is a low-risk option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Health Support Specialist (CHSS) approach for head and neck cancer because it offers a non-clinical, personalized support system that addresses patients' social and logistical needs. Unlike traditional treatments that focus solely on medical interventions, the CHSS model actively helps patients overcome barriers to care by providing resource referrals and ensuring clear communication with healthcare providers. This supportive navigation could lead to more timely and effective treatment initiation, potentially improving overall patient outcomes.

What evidence suggests that this community health support program is effective for head and neck cancer patients?

Research has shown that community health support helps patients with head and neck cancer access care more quickly. For example, a case study found that community outreach programs assist patients in overcoming common obstacles like transportation and communication, which often hinder cancer treatment. Evidence indicates that community health workers play a crucial role in connecting these patients to necessary resources. These efforts have been linked to better health outcomes by reducing the time it takes for patients to begin treatment. This trial will evaluate the effectiveness of a Community Health Support Specialist (CHSS) in providing structured, non-clinical support to participants, focusing on identifying social and logistical barriers to cancer care. This approach is particularly beneficial for patients facing social and logistical challenges. ^{1 3 6 7 8}

Who Is on the Research Team?

David Schwartz, MD

Principal Investigator

University of Tennessee

Are You a Good Fit for This Trial?

This trial is for patients diagnosed with head and neck cancer after visiting an emergency department. It's aimed at those who are younger, possibly underinsured, and facing barriers to timely care. Participants must be able to receive phone or text communication within 72 hours of ED discharge.

Inclusion Criteria

Able to provide verbal consent or have a caregiver available to provide consent on behalf of the patient

I am 18 years old or older.

Resident within the regional catchment area of participating UTHSC-affiliated hospitals (Methodist University Hospital or Regional One Health)

Exclusion Criteria

Incarcerated or otherwise unable to provide voluntary consent

Lacks phone access or unable to be reached after three attempts by CHSS staff

Expected survival less than 4 weeks as determined by the treating team

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

CHSS Support Intervention

Participants receive structured, non-clinical support from a trained Community Health Support Specialist (CHSS) through phone or text outreach after discharge from the emergency department. Contacts focus on identifying social and logistical barriers to cancer care, providing resource referrals, and communicating with provider offices as needed.

Up to 90 days

At least 2 contacts (phone or text)

Follow-up

Participants are monitored for the resolution of barriers and effectiveness of the CHSS intervention

Up to 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Support Specialist (CHSS)

Trial Overview The study tests a community-based navigation program where Community Health Support Specialists help overcome care access barriers like transportation and insurance issues. All participants will get this support, compared against past patient data.

How Is the Trial Designed?

Group I: Community Health Support Specialist (CHSS) Navigation Experimental Treatment 1 Intervention

Participants will receive structured, non-clinical support from a trained Community Health Support Specialist (CHSS) through phone or text outreach after discharge from the emergency department. Contacts will focus on identifying social and logistical barriers to cancer care, providing resource referrals, and communicating with provider offices as needed. Each participant will receive at least two CHSS contacts before treatment initiation.

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+

Methodist University Hospital

Collaborator

Regional One Health

Collaborator

Trials

5

Recruited

990+

UTHSC Cancer Center

Collaborator

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35298354/

The role of community healthcare workers in head and ... This review highlights ways in which CHWs can be deployed to meet the growing demand for HNC services. The existing evidence suggests that CHWs ...

2. jons-online.com jons-online.com/issues/2016/february-2016-vol-7-no-1/novice-navigator-a-case-study-on-community-outreach-for-head-and-neck-cancers2

Novice Navigator: A Case Study on Community Outreach ... This case study demonstrates the unique and complex challenges patients with head and neck cancers face.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11906576/

Patient-reported outcomes in head and neck cancer Patients with early-stage disease reported significantly better physical scores (Md = 90.8, IQR 76.6–100, M ± SD = 86.6 ± 14.1) than those with ...

4. cancer.gov cancer.gov/about-cancer/coping/family-friends/family-caregivers-hp-pdq

Informal Caregivers in Cancer (PDQ®) - NCI 72% assisted with medical tasks. 43% reported needing help to manage emotional and physical stress. 40% wanted help making end-of-life decisions ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8665427/

Targets for improving disparate head and neck cancer ... Here, we conduct a review on the current literature on head and neck cancer outcomes in the low‐income population and identify targets for intervention.

6. meddatax.com meddatax.com/clinical-trials/NCT07225725

Access to Care Pilot for ED-Presenting Head and Neck ... This is a single-arm, prospective pilot study evaluating the feasibility and process impact of embedding Community Health Support Specialist ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9299932/

Head and neck cancers: Monitoring quality and reporting ... The 5‐year overall survival was 69.4% (CI; 64–73.2%). The cumulative incidence of locoregional relapse for the overall study cohort was 18% (CI; ...

8. thecommunityguide.org thecommunityguide.org/findings/cancer-screening-interventions-engaging-community-health-workers-cervical-cancer.html

Cervical Cancer: Community Health Workers Task Force recommends engaging community health workers to increase screening cervical cancer by Pap smear. Read effectiveness and economic evidence.