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

11 mai 2026 mis à jour par: Nikhil Thiruvengadam, Loma Linda University

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.

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

d. Overall study design

This will be a pilot randomized controlled trial where the investigators will plan on randomizing patients with PDAC in a 1:1 fashion to receive a digitally-enhanced community health worker intervention that will involve visits with the CHW and digital communication to facilitate care navigation and provide early palliative care engagement or usual care.

e. Study Procedures and Schedule

Recruitment of subjects for the study

To recruit patients for the interviews, the investigators will screen all of the patients who present for endoscopic ultrasound (with biopsy) to the endoscopy unit or pre-procedure clinic at Loma Linda, as well as patients referred to the medical or surgical oncology clinics with a new diagnosis of pancreatic adenocarcinoma. The investigators will recruit patients from our gastroenterology clinic and endoscopic unit and the oncology clinic (the researcher's patients) both in person and over the phone via a telephone call. The investigators will not contact patients outside our clinical practice but will distribute an IRB-approved flyer with our number to oncology clinics that patients can call and leave a voicemail or email us at our secure HIPPA-complaint Loma Linda email address assigned to our study (cancerresearch@llu.edu). The investigators will also distribute an IRB-approved letter to other oncologists informing them of the study so they can distribute the flyer to their patients and inform patients who may be candidates for this study. The reason the investigators are including patients with suspected PDAC is to eliminate delays once they receive a diagnosis as patients previously reported a flurry of medical visits in the 2 weeks after diagnosis. However, patients will need to undergo a biopsy and have pathology confirmation before study initiation. Patients found to have other pathology on biopsy than pancreatic adenocarcinoma will be excluded. The investigators will explain the study inperson or over the phone when they are referred for a pancreatic biopsy or for oncologic care for a new diagnosis of pancreatic cancer. The investigators will explain that the investigators are recruiting them because they have pancreatic cancer and want to study if a community health worker can help patients like themselves navigate care and engage with palliative care better than the current care that patients receive. If they are interested, they will then be consented using written informed consent at their clinic visit in the clinic or prior to their in-person study visit.

When a patient is diagnosed with PDAC, they receive the diagnosis over the phone and follow-up in clinic. They are referred to medical and surgical oncology and to palliative care for supportive care..

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • Loma Linda, California, États-Unis, 92886
        • Recrutement
        • Loma Linda University Health
        • Contact:
        • Contact:
        • Chercheur principal:
          • Nikhil Thiruvengadam, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Comportemental: 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.
Comparateur actif: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index
Délai: 12 weeks
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Functional Assessment of Cancer Therapy Hepatobiliary
Délai: 12 weeks
The FACT-Hep score measures quality of life in patients with pancreatic, biliary and liver cancers. The total score ranges from 0 to 180, with higher scores indicating better quality of life.
12 weeks
Preparedness for Caregiving Scale
Délai: 12 weeks
The score ranges from 0 to 5 and represents the mean of 8 questions. A higher score is better. It is designed to capture caregiver preparedness.
12 weeks
City of Hope Caregiver QoL Instrument
Délai: 12 weeks
This instrument score represents a mean of subscores and ranges from 0 to 10 with a higher score indicating better caregiver QoL
12 weeks
Goal Concordant Care
Délai: 12 weeks
This outcome will not be determined quantitatively but rather qualitatively by conducting interviews with the patient and caregiver (only the caregiver if the patient dies prior to 12 weeks). Thematic analyses will be peformed with the goal of identifying if the patient and caregiver feel that the care they received reflected their treatment goals.
12 weeks
National Comprehensive Cancer Network Distress Thermometer for Patients
Délai: 12 weeks
This measures psychological distress in pateints and scores from 0 to 10, with a lower score being better, i.e., representing lower levels of psychological distress.
12 weeks
National Comprehensive Cancer Center Distress Thermometer for Caregivers
Délai: 12 weeks
This measures psychological distress in caregivers and yields scores from 0 to 10, with lower scores indicating lower levels of psychological distress.
12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Loma Linda University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2025

Achèvement primaire (Estimé)

1 septembre 2026

Achèvement de l'étude (Estimé)

1 septembre 2026

Dates d'inscription aux études

Première soumission

6 mai 2026

Première soumission répondant aux critères de contrôle qualité

11 mai 2026

Première publication (Réel)

15 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 5250314
  • PA230343 (Autre subvention/numéro de financement: DOD/CDMRP)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Due to the sensitive nature of personal health information and cancer, the investigators will not share patient data with other researchers.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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