A Tailored, Web-Based Self-Management Program to Treat Pain in Chronic Pancreatitis

NCT07223554 | Completed

• 1 other identifier: HUM00277458
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This research study aims to evaluate the feasibility and acceptability of a web-based, self-guided, disease-specific self-management program tailored to individual health status profiles for patients with painful chronic pancreatitis.

Conditions

Chronic Pancreatitis

Keywords

Behavioral intervention; Self-management; Pain

Outcome Measures

Primary Outcomes (2)

• Proportion of enrolled participants that log in at least once during weeks 1-4 and at least once to the recommended modules during weeks 5-12.

  This number is used to determine adherence to the intervention.

  12 weeks

• Proportion of participants with an average item score of ≥4 out of 5 on the Acceptability of Healthcare Interventions Questionnaire

  This is a validated 8-item questionnaire that assesses acceptability using a 5-point Likert scale rated 1-5.

  12 weeks

Secondary Outcomes (7)

• Proportion of participants approached that enroll in the study.

  Approximately 1 year (during recruitment period)

• Proportion of enrolled participants that log in at least once during the 12-week program

  12 weeks

• Proportion of enrolled participants that log in at least once a week during weeks 1-4 and at least once a week to the recommended modules during weeks 5-12.

  12 weeks

• Number of logins per participant during the 12-week intervention

  12 weeks

• Proportion of fully completed questionnaires by the total number given to participants

  12 weeks

Study Arms (1)

Web-based self-management program

EXPERIMENTAL

Participants will be assigned to a web-based, self-management program that has been adapted to chronic pancreatitis. Participants will participate in this program for 12 weeks.

Behavioral: Web-based self--management program

Interventions

Web-based self--management program BEHAVIORAL

Participants in this study will be granted access to the adapted website after participants complete baseline questionnaires. All participants will be encouraged to engage with all the sections of the website. From week 1 to 4, participants will receive a single standardized guidance to complete one module a week on generic pain modules. From weeks 5 to 12, participants will receive weekly tailored messaging that will direct participants to specific modules based on individual survey scores from the baseline assessments.

Web-based self-management program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosis of chronic pancreatitis.
• Abdominal pain for ≥ 3 months and of intensity rated at least 4 or higher on a 0-10 Numeric Rating Scale at least once in the last month.
• Access to an Internet-connected device (e.g. computer or phone).

You may not qualify if:

• Unable to speak or read English as the web-based program is currently in English language only.
• Incarcerated individuals.
• Currently receiving chemotherapy.
• Suspected or diagnosed pancreatic cancer.
• Currently receiving psychotherapy or cognitive behavioral therapy.
• Serious visual difficulties that would limit completing the web-based program.
• Substantial cognitive impairment or mental illness that would prevent providing informed consent and completion of questionnaires.
• Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study.
• Actively enrolled in another clinical trial for chronic pancreatitis.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Pain

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jorge Machicado, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: November 3, 2025
• Study Start: December 4, 2025
• Primary Completion: April 28, 2026
• Study Completion: April 28, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)