Journal article
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)
Contemporary clinical trials, Vol.88, pp.105898-105898
01/01/2020
DOI: 10.1016/j.cct.2019.105898
PMCID: PMC6952537
PMID: 31756383
Abstract
Introduction: Abdominal pain is common and is associated with high disease burden and health care costs in pediatric acute recurrent and chronic pancreatitis (ARP/CP). Despite the strong central component of pain in ARP/CP and the efficacy of psychological therapies for other centralized pain syndromes, no studies have evaluated psychological pain interventions in children with ARP/CP. The current trial seeks to 1) evaluate the efficacy of a psychological pain intervention for pediatric ARP/CP, and 2) examine baseline patient-specific genetic, clinical, and psychosocial characteristics that may predict or moderate treatment response.
Methods: This single-blinded randomized placebo-controlled multicenter trial aims to enroll 260 youth (ages 10-18) with ARP/CP and their parents from twenty-one INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers. Participants will be randomly assigned to either a web-based cognitive behavioral pain management intervention (Web-based Management of Adolescent Pain Chronic Pancreatitis; WebMAP; N = 130) or to a web-based pain education program (WebED; N = 130). Assessments will be completed at baseline (T1), immediately after completion of the intervention (T2) and at 6 months post-intervention (T3). The primary study outcome is abdominal pain severity. Secondary outcomes include pain-related disability, pain interference, health-related quality of life, emotional distress, impact of pain, opioid use, and healthcare utilization.
Conclusions: This is the first clinical trial to evaluate the efficacy of a psychological pain intervention for children with CP for reduction of abdominal pain and improvement of health-related quality of life. Findings will inform delivery of web-based pain management and potentially identify patient-specific biological and psychosocial factors associated with favorable response to therapy.
Details
- Title: Subtitle
- 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)
- Creators
- Tonya M. Palermo - Seattle Children's Research InstituteCaitlin Murray - Seattle Children's Research InstituteHomer Aalfs - Seattle Children's Research InstituteMaisam Abu-El-Haija - Cincinnati Children's Hospital Medical CenterBradley Barth - The University of Texas Southwestern Medical CenterMelena D. Bellin - University of MinnesotaKate Ellery - Children's Hospital of PittsburghDouglas S. Fishman - Baylor College of MedicineCheryl E. Gariepy - Nationwide Children's HospitalMatthew J. Giefer - Seattle Children’s Hospital, Seattle, WA, USA;Praveen Goday - Medical College of WisconsinTanja Gonska - Hospital for Sick ChildrenMelvin B. Heyman - University of California, San FranciscoSohail Z. Husain - Stanford UniversityTom K. Lin - Cincinnati Children's Hospital Medical CenterQuin Y. Liu - Cedars-Sinai Medical CenterMaria R. Mascarenhas - Children's Hospital of PhiladelphiaAsim Maqbool - Children's Hospital of PhiladelphiaBrian McFerron - Riley Hospital for ChildrenVeronique D. Morinville - Montreal Children's HospitalJaimie D. Nathan - Cincinnati Children's Hospital Medical CenterChee Y. Ooi - Sydney Children's HospitalEmily R. Perito - University of California, San FranciscoJohn F. Pohl - University of UtahSarah Jane Schwarzenberg - University of MinnesotaZachary M. Sellers - Stanford UniversityJose Serrano - National Institute of Diabetes and Digestive and Kidney DiseasesUzma Shah - Massachusetts General HospitalDavid Troendle - University of MinnesotaYuhua Zheng - Children's Hospital of Los AngelesYing Yuan - The University of Texas MD Anderson Cancer CenterMark Lowe - University of IowaAliye Uc - University of Iowa Stead Family Children's Hospital, Iowa City, IA, USA.Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer
- Resource Type
- Journal article
- Publication Details
- Contemporary clinical trials, Vol.88, pp.105898-105898
- DOI
- 10.1016/j.cct.2019.105898
- PMID
- 31756383
- PMCID
- PMC6952537
- NLM abbreviation
- Contemp Clin Trials
- ISSN
- 1551-7144
- eISSN
- 1559-2030
- Publisher
- Elsevier
- Number of pages
- 7
- Grant note
- R01DK118752; U01 DK108334 / National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) U01DK108334 / NIDDK; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
- Language
- English
- Date published
- 01/01/2020
- Academic Unit
- Stead Family Department of Pediatrics; Radiation Oncology; Gastroenterology, Hepatology, Pancreatology, and Nutrition
- Record Identifier
- 9984312962302771
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