Clinical trial NCT03707431: Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis
Official title: A Randomized Trial of a Web-based Non-pharmacological Pain Intervention for Pediatric Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pancreatitis
Acute Recurrent Pancreatitis
Keywords: Adolescent
Pancreatitis
Pain
Internet Intervention
Behavioral Intervention
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: University of Virginia
name: Washington University School of Medicine
name: M.D. Anderson Cancer Center
name: The University of Texas Health Science Center, Houston
name: Children's Hospital Medical Center, Cincinnati
name: Children's Hospital Los Angeles
name: Children's Hospital of Philadelphia
name: University of Toronto
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Medical College of Wisconsin
name: Massachusetts General Hospital
name: University of Minnesota
name: Ohio State University
name: University of Pittsburgh
name: University of California, San Francisco
name: University of Utah
name: Indiana University
name: Sydney Children's Hospitals Network
name: Cedars-Sinai Medical Center
name: Stanford University
name: Ariel Precision Medicine
name: University of Texas Southwestern Medical Center
First posted: 2018-10-16
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized and double-blinded controlled trial of web-based CBT (WebMAP) vs pain education (WebED).
Primary purpose: TREATMENT

Brief summary: Abdominal pain is common in children with chronic and acute recurring pancreatitis (CP, ARP), 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 pancreatitis, 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/ARP and some community participants to reduce pain, pain-related disability and enhance HRQOL; it will also identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.

Detailed description: Abdominal pain is present in 81% of children and adolescents with CP and ARP. 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 10-19 years) with CP/ARP and their parents from INSPPIRE 2 (INSPPIRE:INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers and pancreatitis community groups (e.g. NPF) 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/ARP 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/ARP.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with CP or ARP
2. ages 10-19 years
3. at least 4 acute pancreatitis flare-ups/attacks in past year, or at least 1 instance of moderate (4/10 pain) pancreatitis/abdominal pain in the past month
4. access to the Internet on any web-enabled device

Exclusion criteria:

1. non-English speaking
2. inability to read at the 5th grade level due to learning problem or developmental delay
3. children with cystic fibrosis who have pancreatic insufficiency at the time of diagnosis
4. patients with Shwachman-Bodian-Diamond Syndrome
5. Acute Recurrent Pancreatitis (ARP) with no evidence of chronic or persistent pain
6. anticipated surgery (TPIAT or other) during study participation

Primary outcomes:
measure: Change in abdominal pain severity
timeFrame: Baseline, 12 weeks, 6 months
Secondary outcomes:
measure: Change in pain-related disability
timeFrame: Baseline, 12 weeks, 6 months
measure: Change in health-related quality of life
timeFrame: Baseline, 12 weeks, 6 months
measure: Change in emotional distress
timeFrame: Baseline, 12 weeks, 6 months
measure: Change in opioid use
timeFrame: Baseline, 12 weeks, 6 months
measure: Change in pain self-efficacy
timeFrame: Baseline, 12 weeks, 6 months
measure: Change in parent impact of pain
timeFrame: Baseline, 12 weeks, 6 months
measure: Change in pain interference
timeFrame: Baseline, 12 weeks, 6 months
measure: Change in health service utilization
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Tonya Palermo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Aliye Uc, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palermo TM, Murray C, Aalfs H, Abu-El-Haija M, Barth B, Bellin MD, Ellery K, Fishman DS, Gariepy CE, Giefer MJ, Goday P, Gonska T, Heyman MB, Husain SZ, Lin TK, Liu QY, Mascarenhas MR, Maqbool A, McFerron B, Morinville VD, Nathan JD, Ooi CY, Perito ER, Pohl JF, Schwarzenberg SJ, Sellers ZM, Serrano J, Shah U, Troendle D, Zheng Y, Yuan Y, Lowe M, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer. Web-based cognitive-behavioral intervention for pain in pediatric acute recurrent and chronic pancreatitis: Protocol of a multicenter randomized controlled trial from the study of chronic pancreatitis, diabetes and pancreatic cancer (CPDPC). Contemp Clin Trials. 2020 Jan;88:105898. doi: 10.1016/j.cct.2019.105898. Epub 2019 Nov 19.