Summary

for people ages 10-17 (full criteria)
study started
estimated completion:

Description

Summary

Abdominal pain is common in children with chronic pancreatitis (CP), and as they continue into adulthood, the disease progresses with increased pain and greater exposure to opioids. Despite the relevancy of early pain self-management for childhood CP, there have been no studies of non-pharmacological pain intervention in this population. The proposed project will evaluate a web-based cognitive behavioral pain management program delivered to a cohort of well-phenotyped children with CP to reduce pain, pain-related disability and enhance HRQOL and will identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.

Official Title

A Randomized Trial of a Web-based Non-pharmacological Pain Intervention for Pediatric Chronic Pancreatitis

Details

Abdominal pain is present in 81% of children and adolescents with chronic pancreatitis (CP). Effective treatments that target pain in these children will lessen the risk of opioid exposure and continued pain and disability into adulthood. We plan to recruit a large multicenter sample of 260 children and adolescents (ages 10-17 years) with CP and their parents from INSPPIRE 2 (INSPPIRE:INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers to evaluate the efficacy of WebMAP, a web-based cognitive behavioral pain management program (CBT). The study design is a two (group) x three (time point) randomized, controlled, double-blinded trial. Participants will be randomly assigned to receive online access to either pain education (WebED) or CBT (WebMAP) over an 8-10 week treatment period. The primary study outcome is abdominal pain symptoms measured at pre-treatment, immediately post-treatment, and at 6-month follow-up. Secondary outcomes include pain-related disability, health-related quality of life, depression and anxiety symptoms, and medication use. This project represents a significant advance in pain management for children with CP by evaluating the first ever nonpharmacologic pain intervention in these patients, which may guide future developments in the management of chronic pain associated with CP.

Keywords

Chronic Pancreatitis Adolescent Pancreatitis Pain Internet Intervention Behavioral Intervention Pancreatitis, Chronic Web-based CBT Pain Education Web-based CBT (WebMAP) Pain Education (WebED)

Eligibility

You can join if…

Open to people ages 10-17

  1. CP is diagnosed in the presence of: (1) typical abdominal pain plus characteristic imaging findings; or (2) exocrine pancreatic insufficiency plus imaging findings; or(3) diabetes plus imaging findings
  2. ages 10-17 years
  3. pain duration > 3 months and pain frequency > once/week
  4. average pain rating ≥ 5 on two items from the Brief Pain Inventory asking about average pain intensity in the past week (0-10 scale) and activity interference due to pain (0-10 scale)
  5. access to the Internet on any web-enabled device

You CAN'T join if...

  1. non-English speaking
  2. inability to read at the 5th grade level due to learning or developmental delay
  3. only 1 attack of acute pancreatitis (AP)
  4. diagnoses of AP based on levels of amylase or lipase ≤ 3 times greater than upper limits of normal without characteristic findings on imaging
  5. children with cystic fibrosis who have pancreatic insufficiency at the time of diagnosis
  6. patients with Shwachman-Bodian-Diamond Syndrome
  7. Acute Recurrent Pancreatitis (ARP) with no evidence of chronic or persistent pain

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Seattle Children's Hospital
ID
NCT03707431
Study Type
Interventional
Last Updated