Clinical trial NCT06386224: Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain
Official title: Internet-Delivered Pain Self-Management to Reduce Pain and Interference in Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatitis
Chronic Pancreatitis
Acute Recurrent Pancreatitis
Keywords: Pancreatitis
Pain
Internet Intervention
Behavioral Intervention
Cognitive Behavioral Therapy
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2024-04-26
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized to the active intervention arm will receive access to the Pancreatitis Pain Course to learn cognitive-behavioral (CBT) pain self-management skills (e.g., changing negative thoughts, relaxation, activity pacing, goal setting). Participants randomized to the control arm will receive access to an education website.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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/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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in pain severity and pain interference
timeFrame: Baseline, 2-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Change in disease-specific pain
timeFrame: Baseline, 2-month follow-up, 6-month follow-up
measure: Change in physical functioning
timeFrame: Baseline, 2-month follow-up, 6-month follow-up
measure: Change in psychological functioning
timeFrame: Baseline, 2-month follow-up, 6-month follow-up
measure: Change in pain catastrophizing
timeFrame: Baseline, 2-month follow-up, 6-month follow-up
measure: Change in sleep disturbance
timeFrame: Baseline, 2-month follow-up, 6-month follow-up
measure: Change in disease specific health-related quality of life
timeFrame: Baseline, 2-month follow-up, 6-month follow-up
measure: Change in patient global impression of change
timeFrame: 2-month follow-up, 6-month follow-up
measure: Change in opioid use
timeFrame: Baseline, 2-month follow-up, 6-month follow-up
measure: Treatment acceptability
timeFrame: 2-month follow-up
measure: Change in substance use
timeFrame: Baseline, 6-month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References: