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

Primary Purpose

Pancreatitis, Chronic, Pancreatitis, Acute Recurrent

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-based CBT intervention
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis, Chronic focused on measuring Pancreatitis, Pain, Internet Intervention, Behavioral Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-based CBT intervention

Wait list control group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Treatment feasibility
Feasibility will be determined by calculating rates of accrual, drop out, compliance, and missing data. Criteria for feasibility success will be based on: accrual rates >70%, attrition rates <15%, minimal technical difficulties (i.e., reported by <10%), adherence rates >80%, and minimal missing data.
Change in pain intensity
Participants will report on presence and intensity of pain daily for 7 days at each assessment period. Pain intensity will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain, and 10 = worst pain. Mean average intensity of the pain reported will serve as the pain measure.
Change in pain-related disability
Participants will report their level of pain-related disability daily for 7 days at each assessment period. Questions of pain-related disability are taken from the Brief Pain Inventory and the Pain Disability Index. These measures assess the extent to which chronic pain disrupts aspects of daily life including social relations, work, mood, sleep, eating, and physical activity. All items are scored on a 0-10 NRS, with higher scores indicating greater disability.
Change in Disease specific and generic health related quality of life (HRQOL)
Participants will complete the 18-item Pancreatitis Quality of Life Instrument to assess for disease-specific HRQOL difficulties. Items are scored on a 0-5 scale where 0 = Not applicable, 1 = Much less, and 5 = Much more. Participants will also complete the 12-item Short-Form Health Survey to assess for general HRQOL.
Change in Medication use
Participants will record their medication use daily for 7 days at each assessment period
Change in Pain self-efficacy
Participants will complete the 4-item Chronic Pain Self-Efficacy Scale. This scale assesses perceived self-efficacy over three factors: pain management, coping with symptoms, and physical function. All items are scored on a 7-point Likert scale where 0 = Not at all confident, and 6 = Completely confident
Change in Psychological distress
Participants will complete the 4-item Anxiety and 4-item Depression subscales of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile to assess for levels of psychological distress over the past week. Items are scored on a 5-point Likert scale ranging from 1 = Never, to 5 = Always.
Change in Sleep and Fatigue
Participants will complete the 4-item Sleep Disturbance and 4-item Fatigue subscales of the PROMIS-29 Profile to assess for problems with fatigue and sleep over the previous week. All items are scored on a 5-point Likert scale ranging 1 = Not at all, to 5 = Very much, except for one sleep item which is scored 1 = very poor, to 5 = Very good.

Full Information

First Posted
October 23, 2017
Last Updated
September 20, 2021
Sponsor
Seattle Children's Hospital
Collaborators
Mayo Clinic, University of Pittsburgh Medical Center, Ohio State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03322644
Brief Title
Internet-based Pain Self-management for Persons With Acute Recurrent and Chronic Pancreatitis Pain
Acronym
IMPACT
Official Title
Development and Feasibility Testing of an Internet-based Pain Self-management Program for Persons With Acute Recurrent and Chronic Pancreatitis Pain (The IMPACT Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
Mayo Clinic, University of Pittsburgh Medical Center, Ohio State University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) are associated with high disease burden across the lifespan. Recurring abdominal pain is the most prevalent and distressing symptom. Pain severity reduces health-related quality of life for individuals with CP and is associated with increased fatigue, anxiety and depressive symptoms, lower general health status, and reduced physical and role functioning. Medical therapies for CP pain have limited efficacy. Cognitive-behavioral interventions (CBT) offer safe and effective alternatives to pharmacological treatments for pain management. In other chronic painful conditions including gastrointestinal disorders, CBT interventions have been effective for reducing pain and pain impact including disability and depressive symptoms. CBT is traditionally provided by trained psychologists working with individual patients one-on-one or in small groups. Access to CBT is limited by availability of providers, with long waiting lists at centers offering CBT. The Internet is an ideal medium to provide pain self-management interventions that are low-cost and sustainable, and internet-based CBT has shown efficacy in children and adults with chronic pain, allowing clinics to greatly extend their reach to patients. The purpose of this study is to test the acceptability, feasibility, and preliminary efficacy of an Internet-delivered CBT pain self-management course for adults with acute recurrent and chronic pancreatitis pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Chronic, Pancreatitis, Acute Recurrent
Keywords
Pancreatitis, Pain, Internet Intervention, Behavioral Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based CBT intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait list control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Internet-based CBT intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment acceptability
Description
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.
Time Frame
Immediately post-treatment
Secondary Outcome Measure Information:
Title
Treatment feasibility
Description
Feasibility will be determined by calculating rates of accrual, drop out, compliance, and missing data. Criteria for feasibility success will be based on: accrual rates >70%, attrition rates <15%, minimal technical difficulties (i.e., reported by <10%), adherence rates >80%, and minimal missing data.
Time Frame
Immediately post-treatment
Title
Change in pain intensity
Description
Participants will report on presence and intensity of pain daily for 7 days at each assessment period. Pain intensity will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain, and 10 = worst pain. Mean average intensity of the pain reported will serve as the pain measure.
Time Frame
Baseline, 3-month follow-up
Title
Change in pain-related disability
Description
Participants will report their level of pain-related disability daily for 7 days at each assessment period. Questions of pain-related disability are taken from the Brief Pain Inventory and the Pain Disability Index. These measures assess the extent to which chronic pain disrupts aspects of daily life including social relations, work, mood, sleep, eating, and physical activity. All items are scored on a 0-10 NRS, with higher scores indicating greater disability.
Time Frame
Baseline, 3-month follow-up
Title
Change in Disease specific and generic health related quality of life (HRQOL)
Description
Participants will complete the 18-item Pancreatitis Quality of Life Instrument to assess for disease-specific HRQOL difficulties. Items are scored on a 0-5 scale where 0 = Not applicable, 1 = Much less, and 5 = Much more. Participants will also complete the 12-item Short-Form Health Survey to assess for general HRQOL.
Time Frame
Baseline, 3-month follow-up
Title
Change in Medication use
Description
Participants will record their medication use daily for 7 days at each assessment period
Time Frame
Baseline, 3-month follow-up
Title
Change in Pain self-efficacy
Description
Participants will complete the 4-item Chronic Pain Self-Efficacy Scale. This scale assesses perceived self-efficacy over three factors: pain management, coping with symptoms, and physical function. All items are scored on a 7-point Likert scale where 0 = Not at all confident, and 6 = Completely confident
Time Frame
Baseline, 3-month follow-up
Title
Change in Psychological distress
Description
Participants will complete the 4-item Anxiety and 4-item Depression subscales of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile to assess for levels of psychological distress over the past week. Items are scored on a 5-point Likert scale ranging from 1 = Never, to 5 = Always.
Time Frame
Baseline, 3-month follow-up
Title
Change in Sleep and Fatigue
Description
Participants will complete the 4-item Sleep Disturbance and 4-item Fatigue subscales of the PROMIS-29 Profile to assess for problems with fatigue and sleep over the previous week. All items are scored on a 5-point Likert scale ranging 1 = Not at all, to 5 = Very much, except for one sleep item which is scored 1 = very poor, to 5 = Very good.
Time Frame
Baseline, 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tonya M Palermo, PhD
Organizational Affiliation
Seattle Children's Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34140460
Citation
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.
Results Reference
result
PubMed Identifier
34172622
Citation
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.
Results Reference
derived

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

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