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

2026年5月11日 更新者: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.

調査の概要

詳細な説明

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..

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • California
      • Loma Linda、California、アメリカ、92886
        • 募集
        • Loma Linda University Health
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Nikhil Thiruvengadam, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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
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.
アクティブコンパレータ: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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Functional Assessment of Cancer Therapy Hepatobiliary
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年9月1日

一次修了 (推定)

2026年9月1日

研究の完了 (推定)

2026年9月1日

試験登録日

最初に提出

2026年5月6日

QC基準を満たした最初の提出物

2026年5月11日

最初の投稿 (実際)

2026年5月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月15日

QC基準を満たした最後の更新が送信されました

2026年5月11日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 5250314
  • PA230343 (その他の助成金/資金番号:DOD/CDMRP)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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