Internet-based Pain Self-management for Persons With Acute Recurrent and Chronic Pancreatitis Pain

NCT03322644 | Completed

• 2 other identifiers: Mayo IRB #17-007214U01DK108334
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is the cardinal symptom of acute recurrent and chronic pancreatitis, and available medical treatments have limited efficacy. Pain self-management programs equip patients to minimize the impact of chronic painful conditions on activity, health, and psychosocial functioning. The purpose of the current study is to pilot the use of Internet-delivered pain self-management course in adults with chronic and acute recurrent pancreatitis to generate preliminary feasibility and acceptability data to inform design of a subsequent large randomized controlled trial.

Conditions

Pancreatitis, Chronic; Pancreatitis, Acute Recurrent

Keywords

Pancreatitis; Pain; Internet Intervention; Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

• Treatment acceptability

  Participants will complete a 12-item Treatment Evaluation Inventory questionnaire that assesses satisfaction and acceptability of the course of treatment and satisfaction with the outcome of the intervention. Items are rated on a 5-point Likert scale ranging from 1 = Strongly disagree, to 5 = Strongly agree.

  Immediately post-treatment

Secondary Outcomes (8)

• Treatment feasibility

  Immediately post-treatment

• Change in pain intensity

  Baseline, 3-month follow-up

• Change in pain-related disability

  Baseline, 3-month follow-up

• Change in Disease specific and generic health related quality of life (HRQOL)

  Baseline, 3-month follow-up

• Change in Medication use

  Baseline, 3-month follow-up

Study Arms (2)

Internet-based CBT intervention

EXPERIMENTAL

In addition to standard medical care, participants in the Internet-based CBT group will receive access to the Pancreatitis Pain Course and will be asked to complete all online modules over 2 months using their own smartphone or computer. A coach will guide participants through the weekly lessons.

Behavioral: Internet-based CBT intervention

Wait list control group

NO INTERVENTION

Participants assigned to the Wait list control group will be asked to continue with any recommendations made by their clinic provider and will not be offered any internet-based content until after they complete the 5 month assessments (i.e. Months 5-7).

Interventions

Internet-based CBT intervention BEHAVIORAL

The Internet-delivered Pancreatitis Pain Course consists of 5 lessons: 1) introduction, education, and symptom identification, 2) thought monitoring and challenging, 3) controlled breathing and pleasant activity scheduling, 4) activity pacing, and 5) relapse prevention and goal setting. Participants aim to complete one online lesson weekly for 5 weeks, and have up to 2 months to complete the course. Each lesson has a homework assignment to encourage participants to practice and apply skills. A coach who is part of the Seattle Children's Research Institute study team will make weekly contact with participants in the intervention arm through telephone or secure e-mail, for a period of between 10-15 minutes to encourage participants to work through the Course and apply the skills.

Internet-based CBT intervention

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Able and willing to provide informed consent for participation in this study
• Meet CPDPC criteria for diagnosis of either suspected CP (CPDPC "yellow zone") or definite CP (CPDPC "red zone")
• Have personal internet access on any device (e.g., phone, tablet, computer)
• Has experienced pain intensity rated as 4 or higher on a 0-10 scale in the last month

You may not qualify if:

• Currently undergoing treatment for cancer
• Inability to understand English well enough to complete questionnaires or to participate in treatment
• Severe depression (i.e., indicated by a score \> 22 on the Patient Health Questionnaire (PHQ-9)
• Significant suicidal ideation (i.e., indicated by a score \> 2 to Question 9 of the PHQ-9)
• Acutely suicidal or recent history of attempted suicide or self-harm (i.e., last 12 months)
• Currently receiving treatment with a psychologist

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Mayo Clinic: collaborator
• University of Pittsburgh Medical Center: collaborator
• Ohio State University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Palermo TM, Law EF, Topazian MD, Slack K, Dear BF, Ko YJ, Vege SS, Fogel E, Trikudanathan G, Andersen DK, Conwell DL, Yadav D; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Internet Cognitive-Behavioral Therapy for Painful Chronic Pancreatitis: A Pilot Feasibility Randomized Controlled Trial. Clin Transl Gastroenterol. 2021 Jun 18;12(6):e00373. doi: 10.14309/ctg.0000000000000373.

  PMID: 34140460 RESULT

• Yadav D, Palermo TM, Phillips AE, Bellin MD, Conwell DL. Painful chronic pancreatitis - new approaches for evaluation and management. Curr Opin Gastroenterol. 2021 Sep 1;37(5):504-511. doi: 10.1097/MOG.0000000000000769.

  PMID: 34172622 DERIVED

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Tonya M Palermo, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 26, 2017
• Study Start: February 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)