Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeattle Children's Hospital
About this trial
Severe and disabling abdominal pain is common in individuals with chronic pancreatitis. Although pain is associated with reduced quality of life and high economic and societal costs, there are limited effective options for pain management in this population. This study proposes an evidence-based psychological intervention approach using an internet-delivered pain self-management program to minimize the impact of pain and improve quality of life. The ultimate goal is to maximize the public health impact of the intervention with successful implementation and dissemination to pancreas clinics and to the community.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Willingness to use personal device with internet access (smart phone, computer, iPad) or to borrow a study iPad/hotspot
Diagnosis of CP defined as having obvious morphological features of CP (i.e., Cambridge 3-4 stage or the presence of pancreatic calcifications on CT scan and/or magnetic resonance cholangiopancreatography)
Diagnosis of RAP defined as having abdominal pain of a duration of >=3 months, one episode of acute pancreatitis (AP), or RAP.
Disqualifiers
Undergoing treatment for cancer
Unable to read English well enough to complete questionnaires or read the study website
Currently experiencing suicidal ideation
Having received endoscopic therapy in the past 30 days
Trial design
Design model
Parallel
Treatments tested in this trial
Internet-delivered pain self-management (CBT Condition)
BehavioralParticipants will login to the website for 15-20 minutes per week, and complete 5 modules focused on different skills delivered over 8 weeks (e.g., symptom identification, changing negative thoughts, activity pacing)
Education Program
BehavioralParticipants will login to the website for 15-20 minutes per week, and complete 5 modules focusing on pancreatitis pain topics, including: an introduction to pancreatitis, treatment options, specific therapies, surgical procedures.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Internet-delivered pain self-management (CBT Condition)Experimental treatment 1 intervention
Group B: Education ProgramPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain severity and pain interference
The Brief Pain Inventory Short Form (BPI) assesses pain intensity and pain interference in a 24-hour time frame. Participants will complete prospective monitoring for seven days at each assessment. Four pain intensity items evaluate worst, least, average, and current pain intensity and 7 pain intensity items evaluate pain interference with sleep, mood, walking ability, general physical activity, work, relationships, and enjoyment of life.
Time frame
Baseline, 2-month follow-up, 6-month follow-upSecondary outcomes
1
Change in disease-specific pain
The Comprehensive Pain Assessment Tool for Chronic Pancreatitis (COMPAT) is a modified 5-item measure assessing 5 pancreatitis specific pain dimensions (patterns, severity, provocation, spreading, descriptive) and an overall score.
Time frame
Baseline, 2-month follow-up, 6-month follow-up2
Change in physical functioning
The Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b is a modified five-item measure assessing impairment in physical functioning. Responses are rated on a 5-point scale (1-5) with higher scores indicating greater perceived difficulty with activities.
Time frame
Baseline, 2-month follow-up, 6-month follow-up3
Change in psychological functioning
Depressive symptoms will be assessed with the Patient Health Questionnaire (PHQ-9). Anxiety symptoms will be assessed with the Generalized Anxiety Disorder Assessment (GAD-7). Items are scored on a 0-3 scale where 0 = Not at all, 1 = Several Days, 2 = More than half the days and 3 = Nearly every day. Clinical cutoffs are available on both scales to determine clinical severity.
Time frame
Baseline, 2-month follow-up, 6-month follow-up4
Change in pain catastrophizing
The Pain Catastrophizing Scale - Short Form 6 will be used to assess magnification of, rumination about, and hopelessness regarding pain. Items are rated on a 5-point scale (0 = Not at all, 5 = All the time) and summed to create a total score.
Time frame
Baseline, 2-month follow-up, 6-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seattle Children's Hospital
Lead sponsor
University of Kentucky
Collaborator
Source ClinicalTrials.gov