Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer, Adult | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PAL-CHW-PDAC | Behavioral | — | UNRESOLVED |
| Usual Care with Attention Control | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Community Health Worker Intervention
- description
- They work with the community health worker to monitor symptoms and escalate palliative care visits as needed, receive care navigation and disease education
- interventionNames
- Behavioral: PAL-CHW-PDAC
- type
- ACTIVE_COMPARATOR
- label
- Attention Control with Usual Care
- description
- 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.
- interventionNames
- Other: Usual Care with Attention Control
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDThiruvengadam 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
- BACKGROUNDChung 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