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

Last updated: June 10, 2024
Sponsor: Seattle Children's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatitis

Primary Biliary Cholangitis

Treatment

Education Program

Internet-delivered pain self-management (CBT Condition)

Clinical Study ID

NCT06386224
1R01DK137520-01
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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/ormagnetic resonance cholangiopancreatography)

  • Diagnosis of RAP defined as having abdominal pain of a duration of >=3 months, oneepisode of acute pancreatitis (AP), or RAP.

  • Having experienced moderate pain intensity (rated as 4 or higher on a 0-10 NumericalRating Scale) in the last month from RAP or CP.

Exclusion

Exclusion Criteria:

  • Undergoing treatment for cancer

  • Unable to read English well enough to complete questionnaires or read the studywebsite

  • Currently experiencing suicidal ideation

  • Having received endoscopic therapy in the past 30 days

  • Currently receiving treatment from a psychologist (> 4 sessions)

Study Design

Total Participants: 280
Treatment Group(s): 2
Primary Treatment: Education Program
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
September 30, 2026

Study Description

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.

Connect with a study center

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

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