Browsing by Author "Palermo, Tonya M."

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    Clinical Trials in Pancreatitis: Opportunities and Challenges in the Design and Conduct of Patient-Focused Clinical Trials in Recurrent Acute and Chronic Pancreatitis: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop
    (Wolters Kluwer, 2022) Hart, Phil A.; Andersen, Dana K.; Lyons, Erica; Cote, Gregory A.; Cruz-Monserrate, Zobeida; Dworkin, Robert H.; Elmunzer, B. Joseph; Fogel, Evan L.; Forsmark, Christopher E.; Gilron, Ian; Golden, Megan; Gozu, Aysegul; McNair, Lindsay; Pandol, Stephen J.; Perito, Emily R.; Evans Phillips, Anna; Rabbitts, Jennifer A.; Whitcomb, David C.; Windsor, John A.; Yadav, Dhiraj; Palermo, Tonya M.; Medicine, School of Medicine
    Recurrent acute pancreatitis and chronic pancreatitis represent high morbidity diseases, which are frequently associated with chronic abdominal pain, pancreatic insufficiencies, and reduced quality of life. Currently, there are no therapies to reverse or delay disease progression, and clinical trials are needed to investigate potential interventions that would address this important gap. This conference report provides details regarding information shared during a National Institute of Diabetes and Digestive and Kidney Diseases-sponsored workshop on Clinical Trials in Pancreatitis that sought to clearly delineate the current gaps and opportunities related to the design and conduct of patient-focused trials in recurrent acute pancreatitis and chronic pancreatitis. Key stakeholders including representatives from patient advocacy organizations, physician investigators (including clinical trialists), the US Food and Drug Administration, and the National Institutes of Health convened to discuss challenges and opportunities with particular emphasis on lessons learned from trials in participants with other painful conditions, as well as the value of incorporating the patient perspective throughout all stages of trials.
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    Health-Related Quality of Life in Pediatric Acute Recurrent or Chronic Pancreatitis: Association With Biopsychosocial Risk Factors
    (Wiley, 2022) Tham, See Wan; Wang, Fuchenchu; Gariepy, Cheryl E.; Cress, Gretchen A.; Abu-El-Haija, Maisam A.; Bellin, Melena D.; Ellery, Kate M.; Fishman, Douglas S.; Gonska, Tanja; Heyman, Melvin B.; Lin, Tom K.; Maqbool, Asim; McFerron, Brian A.; Morinville, Veronique D.; Nathan, Jaimie D.; Ooi, Chee Y.; Perito, Emily R.; Schwarzenberg, Sarah Jane; Sellers, Zachary M.; Shah, Uzma; Troendle, David M.; Wilschanski, Michael; Zheng, Yuhua; Yuan, Ying; Lowe, Mark E.; Uc, Aliye; Palermo, Tonya M.; INternational Study Group of Pediatric Pancreatitis: In search for a cuRE (INSPPIRE) and Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer (CPDPC); Pediatrics, School of Medicine
    Objectives: Abdominal pain, emergency department visits, and hospitalizations impact lives of children with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP). Data on health-related quality of life (HRQOL) in this population, however, remains limited. We aimed to evaluate HRQOL in children with ARP or CP; and test biopsychosocial risk factors associated with low HRQOL. Methods: Data were acquired from the INternational Study Group of Pediatric Pancreatitis: In search for a cuRE registry. Baseline demographic and clinical questionnaires, the Child Health Questionnaire (measures HRQOL) and Child Behavior Checklist (measures emotional and behavioral functioning) were completed at enrollment. Results: The sample included 368 children (54.3% girls, mean age = 12.7years, standard deviation [SD] = 3.3); 65.2% had ARP and 34.8% with CP. Low physical HRQOL (M = 38.5, SD = 16.0) was demonstrated while psychosocial HRQOL (M = 49.5, SD = 10.2) was in the normative range. Multivariate regression analysis revealed that clinical levels of emotional and behavioral problems (B = -10.28, P < 0.001), episodic and constant abdominal pain (B = 04.66, P = 0.03; B = -13.25, P < 0.001) were associated with low physical HRQOL, after accounting for ARP/CP status, age, sex, exocrine, and endocrine disease (F [9, 271] = 8.34, P < 0.001). Borderline and clinical levels of emotional and behavioral problems (B = -10.18, P < 0.001; B = -15.98, P < 0.001), and constant pain (B = -4.46, P < 0.001) were associated with low psychosocial HRQOL (F [9, 271] = 17.18, P < 0.001). Conclusions: Findings highlight the importance of assessing HRQOL and treating pain and psychosocial problems in this vulnerable group of children.
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    Healthcare Transition Among Young Adults With Childhood-Onset Chronic Pain: A Mixed Methods Study and Proposed Framework
    (Elsevier, 2022) Murray, Caitlin B.; Murphy , Lexa K.; Jordan , Abbie; Owens, Michele Tsai; McLeod , Dorothy; Palermo, Tonya M.; Psychiatry, School of Medicine
    Chronic pain extends from childhood to adulthood for many young people. The transition from pediatric to adult care is a critical, yet understudied, healthcare task facing young adults with chronic pain. The aims of this observational, sequential mixed methods study were to 1) document the healthcare transition status of young adults with chronic pain (Stage 1, quantitative aim), 2) examine young adults' perspectives of barriers and facilitators of healthcare transition (Stage 2, qualitative aim), and 3) integrate findings to construct a theoretical framework of healthcare transition. A cohort was identified with childhood chronic pain and prior care in one of 15 multidisciplinary pediatric pain clinics across the United States and Canada. Approximately 6 years later, 189 young adults (M age = 21.0; age range = 18-24; 81.5% female) from this cohort with continuing chronic pain completed surveys for Stage 1, and a subsample (n = 17) completed qualitative interviews for Stage 2. Quantitative findings demonstrated that young adults may experience lapses in care, with 41.8% indicating they had not transitioned to adult pain services. Qualitative analysis revealed young adults experienced significant barriers (eg, abrupt departure from pediatric care) as well as facilitators (eg, acceptance of pain prognosis) of healthcare transition. Quantitative and qualitative findings were integrated to construct a healthcare transition framework for chronic pain, which highlights transition as a complex process involving multiple pathways, outcomes, and stakeholders. Advancements in research and practice are needed to develop transition services to bridge gaps in care and optimize health outcomes for young people with chronic pain. PERSPECTIVE: This mixed-methods study demonstrated that 41.8% of young adults with chronic pain experience lapses in adult-centered pain care and identified key barriers and facilitators to successful healthcare transition. Findings were integrated to construct the first healthcare transition framework for youth with chronic pain.
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    Internet Cognitive-Behavioral Therapy for Painful Chronic Pancreatitis: A Pilot Feasibility Randomized Controlled Trial
    (Wolters Kluwer, 2021-06-18) Palermo, Tonya M.; Law, Emily F.; Topazian, Mark D.; Slack, Katherine; Dear, Blake F.; Ko, Yeon Joo; Vege, Santhi Swaroop; Fogel, Evan; Trikudanathan, Guru; Andersen, Dana K.; Conwell, Darwin L.; Yadav, Dhiraj; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC); Medicine, School of Medicine
    Introduction: Severe abdominal pain is a cardinal symptom of chronic pancreatitis (CP) associated with a high economic and societal burden. In other chronic pain conditions, cognitive-behavioral therapy (CBT) has demonstrated efficacy in improving patient outcomes (e.g., pain-related disability and depression). However, CBT has not yet been evaluated in adult patients with painful CP. We aimed to (i) evaluate the feasibility and acceptability of an adapted Internet CBT program for CP and (ii) generate pilot data regarding the effects of treatment on patient pain outcomes. Methods: Thirty adults (mean age = 49.8 years, SD = 12.5; 80% women) with suspected or definite CP were randomized to Internet CBT (Pancreatitis Pain Course) versus control. The Pancreatitis Pain Course has 5 CBT lessons (e.g., thought challenging, relaxation, and activity pacing) delivered over 8 weeks. Pain interference, pain intensity, and quality of life were assessed at pretreatment, posttreatment, and the 3-month follow-up. Qualitative interviews were conducted at posttreatment with a subset of participants. Results: Eighty percent of participants rated the program as highly acceptable; 64.3% completed all 5 lessons. Qualitative data revealed positive perceptions of program features, relevancy, and skills. Patients randomized to Internet CBT demonstrated moderate to large effects in reducing pain intensity and pain interference from baseline to 3 months. The proportion of treatment responders (>30% improvement) was significantly greater in the Internet-CBT group than in the control group (50% vs 13%, Fisher exact t test P = 0.04). Discussion: In this first trial of CBT pain self-management in CP, feasibility, acceptability, and preliminary efficacy for reducing pain and disability were demonstrated. Future definitive trials of CBT are needed.
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    Interventions for Pancreatitis-New Approaches, Knowledge Gaps, and Research Opportunities: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop
    (Wolters Kluwer, 2024) Evans Phillips, Anna; Hughes, Steven J.; Andersen, Dana K.; Bell, Adam; Brand, Randall; Coté, Gregory A.; Cowdin, Adriana; Diazgranados, Nancy; Dudeja, Vikas; Duggan, Sinead N.; Fogel, Evan; Forsmark, Chris E.; Freeman, A. Jay; Gittes, George; Hart, Phil A.; Jeon, Christie; Nealon, William; Neoptolemos, John; Palermo, Tonya M.; Pandol, Stephen; Roberts, Kristen M.; Rosenthal, Martin; Singh, Vikesh K.; Yadav, Dhiraj; Whitcomb, David C.; Zyromski, Nicholas; Medicine, School of Medicine
    There exists no cure for acute, recurrent acute or chronic pancreatitis and treatments to date have been focused on managing symptoms. A recent workshop held by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) focused on interventions that might disrupt or perhaps even reverse the natural course of this heterogenous disease, aiming to identify knowledge gaps and research opportunities that might inform future funding initiatives for NIDDK. The breadth and variety of identified active or planned clinical trials traverses the spectrum of the disease and was conceptually grouped for the workshop into behavioral, nutritional, pharmacologic and biologic, and mechanical interventions. Cognitive and other behavioral therapies are proven interventions for pain and addiction, but barriers exist to their use. Whilst a disease specific instrument quantifying pain is now validated, an equivalent is lacking for nutrition - and both face challenges in ease and frequency of administration. Multiple pharmacologic agents hold promise. Ongoing development of Patient Reported Outcome (PRO) measurements can satisfy Investigative New Drug (IND) regulatory assessments. Despite multiple randomized clinical trials demonstrating benefit, great uncertainty remains regarding patient selection, timing of intervention, and type of mechanical intervention (endoscopic versus surgery). Challenges and opportunities to establish beneficial interventions for patients were identified.
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    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)
    (Elsevier, 2020-01) Palermo, Tonya M.; Murray, Caitlin; Aalfs, Homer; Abu-El-Haija, Maisam; Barth, Bradley; Bellin, Melena D.; Ellery, Kate; Fishman, Douglas S.; Gariepy, Cheryl E.; Giefer, Matthew J.; Goday, Praveen; Gonska, Tanja; Heyman, Melvin B.; Husain, Sohail Z.; Lin, Tom K.; Liu, Quin Y.; Mascarenhas, Maria R.; Maqbool, Asim; McFerron, Brian; Morinville, Veronique D.; Nathan, Jaimie D.; Ooi, Chee Y.; Perito, Emily R.; Pohl, John F.; Schwarzenberg, Sarah Jane; Sellers, Zachary M.; Serrano, Jose; Shah, Uzma; Troendle, David; Zheng, Yuhua; Yuan, Ying; Lowe, Mark; Uc, Aliye; Pediatrics, School of Medicine
    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.