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Internet-Delivered Pain Self-Management to Reduce Pain and Interference in Chronic Pancreatitis

互联网提供的疼痛自我管理可减少慢性胰腺炎的疼痛和干扰

基本信息

批准号：
10753896
负责人：
DARWIN LEWIS CONWELL
金额：
$ 90.56万
依托单位：
SEATTLE CHILDREN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2028-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10753896
关键词：
Abdominal Pain Acute Address Anxiety Behavioral Chronic Clinic Clinical Cancer Center Clinical Trials Cognitive Cognitive Therapy Communities Coupled Data Diabetes Mellitus Disease Dissemination and Implementation Economics Education Enrollment Evaluation Evidence based intervention Foundations Gastrointestinal Diseases Goals Healthcare Hospitalization Hybrids Individual Internet Intervention Interview Investigation Learning Malignant neoplasm of pancreas Mental Depression Morbidity - disease rate National Institute of Diabetes and Digestive and Kidney Diseases Observational Study Operative Surgical Procedures Opioid Pain Pain Research Pain interference Pain management Pancreas Pancreatitis Patient Outcomes Assessments Patients Phenotype Physical Function Population Positioning Attribute Practical Robust Implementation and Sustainability Model Pragmatic clinical trial Preparation Process Provider Public Health Quality of life Randomized Recurrence Relaxation Resources Risk Severities Sleep disturbances Structure Symptoms United States United States National Institutes of Health acute pancreatitis anxiety symptoms chronic pain chronic pain management chronic painful condition chronic pancreatitis clinical center cohort common symptom community setting cost depressive symptoms design disability economic cost effectiveness evaluation effectiveness testing effectiveness/implementation design evidence base experience follow-up future implementation health care disparity health related quality of life implementation facilitators improved mortality non-opioid analgesic opioid use pain outcome pain reduction pain self-management patient advocacy group prescription opioid primary outcome process evaluation programs prospective psychologic randomized, clinical trials recruit secondary outcome side effect skills sleep quality social health determinants societal costs treatment effect treatment response web site

项目摘要

Project Summary Severe abdominal pain is a cardinal symptom of pancreatitis, present in up to 90% of patients with recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP). As pain increases in severity and constancy, it is associated with significant morbidity including depression and anxiety symptoms, low physical functioning, sleep disturbance, and low quality of life, as well as high economic and societal burden. Painful RAP and CP is most often managed with chronic opioids, which unfortunately have limited efficacy and substantial risk for adverse side effects. This application focuses on addressing this treatment gap in pain management with a well-established nonpharmacologic intervention. Our team has established efficacy of an internet-delivered cognitive-behavioral therapy (CBT) intervention for chronic pain, and recently adapted it for pancreatitis pain (the Pancreatitis Pain Course), showing promise for reducing pain and disability in this population. We propose a hybrid effectiveness-implementation design type 1 trial to make rapid translational gains with the primary goal of gathering data on CBT treatment effects on pancreatitis pain and pain interference in individuals with RAP and CP with a secondary goal of gathering implementation data to inform dissemination of the Pancreatitis Pain Course to real-world settings. Our central hypothesis is that the Pancreatitis Pain Course will be effective in reducing pain interference and severity in individuals with painful RAP and CP. Our specific aims are to 1) Determine the effectiveness of the Pancreatitis Pain Course in improving pancreatitis pain outcomes, 2) (Exploratory) Explore the moderating effects of social determinants of health with changes in pain interference and severity following treatment, and 3) Identify implementation facilitators, challenges, and solutions for structures and processes that contribute to the seamless integration of the Pancreatitis Pain Course into clinical centers and the community. This study will leverage resources of the Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) Consortium, a NIDDK-sponsored U01 consortium with recruitment from their nine clinical centers and from self-referral in the community through partnership with the National Pancreas Foundation. Using a multicenter randomized-controlled pragmatic clinical trial, we will enroll 280 individuals with painful CP into the clinical trial and randomize them to CBT, providing access to the Pancreatitis Pain Course to learn pain self-management skills (e.g., relaxation, activity pacing, goal setting) or education control (access to education website about RAP and CP pain). We will collect patient-reported outcomes at baseline, two months, and six-month follow-up. Relevant stakeholder groups (patients, providers, organizational managers) will participate in a process evaluation to inform future implementation in clinic and community settings. The proposed investigation will significantly advance solutions for nonopioid pain management in CP. If successful, our project will minimize disparities in care, and address a critical need for low-cost, accessible pain self-management for individuals with painful CP.

项目总结