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

NCT07591571 | Recruiting

• 2 other identifiers: 5250314PA230343
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

community health worker; pancreatic cancer; palliative care

Outcome Measures

Primary Outcomes (1)

• National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index

  This score goes from 0 to 72 with higher scores being better. It measures the symptom burden in pateints with pancreatic, biliary and liver cancers.

  12 weeks

Secondary Outcomes (6)

• Functional Assessment of Cancer Therapy Hepatobiliary

  12 weeks

• Preparedness for Caregiving Scale

  12 weeks

• City of Hope Caregiver QoL Instrument

  12 weeks

• Goal Concordant Care

  12 weeks

• National Comprehensive Cancer Network Distress Thermometer for Patients

  12 weeks

Study Arms (2)

Community Health Worker Intervention

EXPERIMENTAL

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

Behavioral: PAL-CHW-PDAC

Attention Control with Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care with Attention Control

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.

Community Health Worker Intervention

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.

Attention Control with Usual Care

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Biopsy Does not Confirm Adenocarcinoma of the Pancreas

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92886, United States

RECRUITING

Related Publications (2)

• Thiruvengadam NR, Kouanda A, Kalluri A, Schaubel D, Saumoy M, Forde K, Song J, Faggen A, Davis BG, Onwugaje KC, Cote G, Arain MA, Kochman ML. A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity. Clin Gastroenterol Hepatol. 2023 May;21(5):1233-1242.e14. doi: 10.1016/j.cgh.2022.08.034. Epub 2022 Sep 6.

  PMID: 36075501 BACKGROUND

• Chung V, Sun V, Ruel N, Smith TJ, Ferrell BR. Improving Palliative Care and Quality of Life in Pancreatic Cancer Patients. J Palliat Med. 2022 May;25(5):720-727. doi: 10.1089/jpm.2021.0187. Epub 2021 Oct 26.

  PMID: 34704841 BACKGROUND

MeSH Terms

Conditions

Pancreatic cancer, adult; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Nikhil Thiruvengadam, MD

CONTACT

9095584668; nthiruvengadam@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 15, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)