Chronic Pancreatitis Clinical Trial
Official title:
A Randomized Trial of a Web-based Non-pharmacological Pain Intervention for Pediatric Chronic Pancreatitis
Verified date | January 2024 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 19 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Seattle Children's Hospital | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital | Ariel Precision Medicine, Cedars-Sinai Medical Center, Children's Hospital Los Angeles, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Indiana University, M.D. Anderson Cancer Center, Massachusetts General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre, Medical College of Wisconsin, Ohio State University, Stanford University, Sydney Children's Hospitals Network, The University of Texas Health Science Center, Houston, University of California, San Francisco, University of Iowa, University of Minnesota, University of Pittsburgh, University of Texas Southwestern Medical Center, University of Toronto, University of Utah, University of Virginia, Washington University School of Medicine |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in abdominal pain severity | The Abdominal Pain Index (API) assesses characteristics of abdominal pain during the previous 2 weeks including the number of days with pain, number of pain episodes per day, typical pain episode duration, and typical pain intensity. An index is computed with higher scores indicating greater abdominal pain severity. | Baseline, 12 weeks, 6 months | |
Secondary | Change in pain-related disability | The Child Activity Limitations Interview (CALI-9) is a daily diary validated to assess perceived difficulty in completing 9 daily activities as a measure of pain-related disability. Responses are rated on a 5-point scale (0-4) with higher scores indicating greater perceived difficulty with activities. Youth will provide ratings daily for 7 days on their online diaries at each assessment period. Mean total activity limitations across the reporting period is used in analyses, with higher scores indicating greater disability. | Baseline, 12 weeks, 6 months | |
Secondary | Change in health-related quality of life | The Pediatric Quality of Life Inventory (Peds-QL) assesses several domains of functioning, including physical, social, emotional, and academic functioning. The PedsQL is widely used as it demonstrates good reliability for both the parent and child self-report measures. Higher scores indicate fewer difficulties (better) health-related quality of life. Sub scales of physical and psychosocial health will be used in analyses. | Baseline, 12 weeks, 6 months | |
Secondary | Change in emotional distress | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of depressive symptoms that evaluates negative mood, view of self and social cognitions. Raw scores and T-scores are computed with T-scores above 60 indicating clinically elevated symptoms. | Baseline, 12 weeks, 6 months | |
Secondary | Change in opioid use | Youth and parents will report on over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days. | Baseline, 12 weeks, 6 months | |
Secondary | Change in pain self-efficacy | The Pain Self-Efficacy Scale is a 7-item measure that assesses the child's beliefs in carrying out activities when in pain. The scale has demonstrated good internal consistency, cross-informant reliability with parent report, and strong construct validity. Higher scores indicate higher self-efficacy. | Baseline, 12 weeks, 6 months | |
Secondary | Change in parent impact of pain | Parents will complete the Bath Adolescent Pain Questionnaire-Parent Impact Questionnaire (BAPQ-PIQ), a measure of the impact of parenting an adolescent with chronic pain. The BAPQ-PIQ is a 62-item questionnaire with 8 scales including: depressive symptoms, anxiety, pain catastrophizing, self-blame, partner relationship, social functioning, parental behavior, and parental role strain. Items are rated on a 5-point frequency response scale (0 = never, 4 = always) with higher scores indicating more impaired functioning for all subscales. The BAPQ-PIQ has demonstrated good reliability and validity among parents of youth with chronic pain. Sub scales will be analyzed separately. | Baseline, 12 weeks, 6 months | |
Secondary | Change in pain interference | The PROMIS Pain Interference - Pediatric Short Form includes 8 items to assess consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The scale has been validated in pediatric patients with chronic pain. Raw scores and T-scores are computed with T-scores above 60 indicating clinically elevated symptoms. | Baseline, 12 weeks, 6 months | |
Secondary | Change in health service utilization | Parents will complete the Client Service Receipt Inventory-Pain version, a measure of service use, out-of-pocket expenses, and lost work time incurred by families for the evaluation or management of the child's chronic pain. Questions pertain to hospital admissions, outpatient services, community services (e.g., tutor, lawyer), medications, lost work time, paid help, and other costs. We will compute the following variables: total number of services used by category, number of lost parental work days, and number of out-of-pocket expenses.
visits, medications, other treatments, and indirect costs as reported by the parent. |
Baseline, 6 months |
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