Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386224
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-04-23
Brief Title:
Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Internet-Delivered Pain Self-Management to Reduce Pain and Interference in Chronic Pancreatitis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT-2
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None