Recruiting

Community Health Worker

Sponsor:

Loma Linda University

Code:

NCT07591571

Conditions

Pancreatic Cancer, Adult

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

PAL-CHW-PDAC

Usual Care with Attention Control

Study Details

Brief summary:

The goal of this clinical trial is to learn if a community health worker led intervention that helps facilitate palliative care works to treat newly-diagnostic pancreatic cancer. It will also help understand the impact of this intervention on people who are caregivers for patients with pancreatic cancer. The main questions it aims to answer are:

Does the community health worker improve symptoms and quality of life in patients with pancreatic cancer? Does the community health worker improve the burden of caregiving and quality of life in family caregivers? Researchers will compare drug ABC to a control (where patients get the care that patients with pancreatic cancer receive including access to handouts and videos that the investigators provide patients by national organizations) to see if the intervention works to help patients with pancreatic cancer.

Participants will:

Meet with study staff several times over 3 months and complete surveys about their experience and symptoms Patients assigned with the community health worker will meet with them in person or video.

Conditions

Pancreatic Cancer, Adult

Study ID

NCT07591571

Start date

Sep 1, 2025

Status verified date

May, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Age 18 to 90
  • English or Spanish-Speaking
  • Diagnosed with Newly-Diagnosed Pancreatic Adenocarcinoma or has a pancreatic mass on CT/MRI with suspected PDAC and is awaiting biopsy.
  • Able to communicate verbally to allow for audio recording to complete an exit interview
  • Must be able to consent

Exclusion criteria:

• Biopsy Does not Confirm Adenocarcinoma of the Pancreas

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Community Health Worker Intervention

They work with the community health worker to monitor symptoms and escalate palliative care visits as needed, receive care navigation and disease education

active comparator: Attention Control with Usual Care

They receive usual care at our institution, including a referral to palliative care at diagnosis, referrals to oncology and medical oncology, and also the handouts from PANCAN provided in clinic, and access to videos from the National Pancreas Foundation.

Interventions

PAL-CHW-PDAC

The intervention involves meeting with a community health worker who will address quality of life concerns, including physical, spiritual, social, and psychological concerns, help patients schedule visits, and set them up to receive telehealth. They also monitor their symptoms via weekly text messages and receive help managing them. Finally, they help patients complete advanced care planning.

Usual Care with Attention Control

This involves usual care at our institution, including referrals to medical oncology, surgical oncology, and palliative care but they also receive attention from the study coordinator completing 3 visits including survey instruments and are provided standard of care written and media-based materials from PANCAN and the National Pancreas Foundation.

Primary outcome measure

  • National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Nikhil Thiruvengadam, MD

9095584668nthiruvengadam@llu.edu

Locations

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92886

Contacts

Nikhil Thiruvengadam, MD

9095584668nthiruvengadam@llu.edu

Susanne Montgomery, PhD

9095584668smontgomery@llu.edu

Principal Investigator:

Nikhil Thiruvengadam, MD

More Information

Sponsor

Loma Linda University

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • community health worker
  • pancreatic cancer
  • palliative care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-05-15.