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

NCT ID: NCT07223554

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-04
• Study Completion Date: 2027-03-31

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.

Detailed Description

This is a single center, prospective, open-label, pilot trial of 30 patients with painful chronic pancreatitis (CP). Participants will be assigned to a 12-week web-based, self-management program known as PainGuide that has been adapted to CP. Participants will receive specific instruction to complete one module a week over the first 4 weeks. Next, participants will receive weekly tailored messaging for the last 8 weeks using symptom scores from baseline assessments and will be asked to complete modules that best address participants symptoms. Participants will complete online surveys at baseline, 4 weeks, 8 weeks, and 12 weeks, and will be interviewed at the end of program to understand participants perceptions on the intervention.

Conditions

Chronic Pancreatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Web-based self-management program

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.

Group Type: EXPERIMENTAL

Web-based self--management program

Intervention Type: 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.

Interventions

Web-based self--management program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jorge Machicado, MD, MPH

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jorge Machicado, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Angela Theil

Role: CONTACT

atheil@umich.edu

734-998-1147

Facility Contacts

Angela Theil

Role: primary

atheil@umich.edu

734-998-1147

Other Identifiers

HUM00277458

Identifier Type: -

Identifier Source: org_study_id