Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain

Официальное название

Internet-Delivered Pain Self-Management to Reduce Pain and Interference in Chronic Pancreatitis

Обзор

Severe and disabling abdominal pain is common in individuals with chronic pancreatitis. Although pain is associated with reduced quality of life and high economic and societal costs, there are limited effective options for pain management in this population. This study proposes an evidence-based psychological intervention approach using an internet-delivered pain self-management program to minimize the impact of pain and improve quality of life. The ultimate goal is to maximize the public health impact of the intervention with successful implementation and dissemination to pancreas clinics and to the community.

Подробное описание

Severe abdominal pain is a cardinal symptom of pancreatitis, present in up to 90% of patients with recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP). As pain increases in severity and constancy, it is associated with significant morbidity including depression and anxiety symptoms, low physical functioning, sleep disturbance, and low quality of life, as well as high economic and societal burden. This application focuses on addressing this treatment gap in pain management with a well-established nonpharmacologic intervention. The investigators propose a hybrid effectiveness-implementation design type 1 trial to make rapid translational gains with the primary goal of gathering data on treatment effects of internet-delivered pain self-management on pancreatitis pain and pain interference in individuals with RAP and CP with a secondary goal of gathering implementation data to inform dissemination of the program to real-world settings. Our central hypothesis is that pain self-management will be effective in reducing pain interference and severity in individuals with painful RAP and CP. This study will leverage resources of the Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) Consortium, a National Institute of Diabetes and Digestive and Kidney Diseases-sponsored U01 consortium with recruitment from their nine clinical centers and from self-referral in the community through partnership with the National Pancreas Foundation. Using a multicenter randomized-controlled pragmatic clinical trial, the study team will enroll 280 individuals with painful CP into the clinical trial and randomize them to learn pain self-management skills (e.g., relaxation, activity pacing, goal setting) or receive education, and will collect patient-reported outcomes at baseline, two months, and six-month follow-up. Relevant stakeholder groups (patients, providers, organizational managers) will participate in a process evaluation to inform future implementation in clinic and community settings. The proposed investigation will significantly advance solutions for nonopioid pain management in CP.

Вмешательства

• Поведенческое Internet-delivered pain self-management (CBT Condition)
  Participants will login to the website for 15-20 minutes per week, and complete 5 modules focused on different skills delivered over 8 weeks (e.g., symptom identification, changing negative thoughts, activity pacing)
• Поведенческое Education Program
  Participants will login to the website for 15-20 minutes per week, and complete 5 modules focusing on pancreatitis pain topics, including: an introduction to pancreatitis, treatment options, specific therapies, surgical procedures.

Первичные конечные точки

• Change in pain severity and pain interference [Срок оценки: Baseline, 2-month follow-up, 6-month follow-up]

Вторичные конечные точки (10)

• Change in disease-specific pain [Срок оценки: Baseline, 2-month follow-up, 6-month follow-up]
• Change in physical functioning [Срок оценки: Baseline, 2-month follow-up, 6-month follow-up]
• Change in psychological functioning [Срок оценки: Baseline, 2-month follow-up, 6-month follow-up]
• Change in pain catastrophizing [Срок оценки: Baseline, 2-month follow-up, 6-month follow-up]
• Change in sleep disturbance [Срок оценки: Baseline, 2-month follow-up, 6-month follow-up]
• Change in disease specific health-related quality of life [Срок оценки: Baseline, 2-month follow-up, 6-month follow-up]
• Change in patient global impression of change [Срок оценки: 2-month follow-up, 6-month follow-up]
• Change in opioid use [Срок оценки: Baseline, 2-month follow-up, 6-month follow-up]
• Treatment acceptability [Срок оценки: 2-month follow-up]
• Change in substance use [Срок оценки: Baseline, 6-month follow-up]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Willingness to use personal device with internet access (smart phone, computer, iPad) or to borrow a study iPad/hotspot
• Diagnosis of CP defined as having obvious morphological features of CP (i.e., Cambridge 3-4 stage or the presence of pancreatic calcifications on CT scan and/or magnetic resonance cholangiopancreatography)
• Diagnosis of RAP defined as having abdominal pain of a duration of >=3 months, one episode of acute pancreatitis (AP), or RAP.
• Having experienced moderate pain intensity (rated as 4 or higher on a 0-10 Numerical Rating Scale) in the last month from RAP or CP.

Критерии исключения

• Undergoing treatment for cancer
• Unable to read English well enough to complete questionnaires or read the study website
• Currently experiencing suicidal ideation
• Having received endoscopic therapy in the past 30 days
• Currently receiving treatment from a psychologist (> 4 sessions)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Seattle Children's Hospital — Seattle

Публикации

• Palermo TM, Ohls O, Dear B, Doorenbos AZ, Yadav D, Zhou C, Bellin M, Fisher W, Fogel E, Forsmark C, Hart PA, Park WG, Pandol S, Trikudanathan G, Conwell DL. Digital cognitive-behavioral therapy for pain management in individuals with recurrent acute and chronic pancreatitis (IMPACT-2): study protocol for a hybrid effectiveness-implementation trial. Trials. 2026 Feb 9;27(1):204. doi: 10.1186/s13063 PMID 41664170

Идентификаторы

NCT: NCT06386224 · 1R01DK137520-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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