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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT07591571
Status
Recruiting
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Conditions

  • Pancreatic Cancer, Adult

Eligibility Criteria

Sex
ALL
Age
18 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • PAL-CHW-PDAC — BEHAVIORAL
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda University HealthLoma LindaCalifornia92886
Nikhil Thiruvengadam, MD
[email protected]
9095584668
Susanne Montgomery, PhD
[email protected]
9095584668
Nikhil Thiruvengadam, MD (PRINCIPAL_INVESTIGATOR)

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