RecruitingNot ApplicableNCT07591571

To Evaluate the Preliminary Efficacy of Our Digitally Enhanced CHW-led Intervention in Newly Diagnosed PDAC

To Evaluate the Preliminary Efficacy of Our Digitally Enhanced CHW-led Intervention in Newly Diagnosed PDAC With a Pilot Randomized Controlled Trial of 60 PDAC Patients and Their Caregivers Comparing the Intervention to Attention Control With Usual Care.


Sponsor

Loma Linda University

Enrollment

60 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Months

Inclusion Criteria5

  • 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 Criteria1

  • Biopsy Does not Confirm Adenocarcinoma of the Pancreas

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Interventions

BEHAVIORALPAL-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.

OTHERUsual 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.


Locations(1)

Loma Linda University Health

Loma Linda, California, United States

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NCT07591571


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