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Trial record 37 of 901 for:    Recruiting, Not yet recruiting, Available Studies | "Pancreatic Diseases"

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

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ClinicalTrials.gov Identifier: NCT03322644
Recruitment Status : Not yet recruiting
First Posted : October 26, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Mayo Clinic
University of Pittsburgh
Ohio State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tonya Palermo, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreatitis, Chronic Pancreatitis, Acute Recurrent Behavioral: Internet-based CBT intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Internet-based CBT intervention
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
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.
No Intervention: Wait list control group
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).



Primary Outcome Measures :
  1. Treatment acceptability [ Time Frame: Immediately post-treatment ]
    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 :
  1. Treatment feasibility [ Time Frame: Immediately post-treatment ]
    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.

  2. Change in pain intensity [ Time Frame: Baseline, 3-month follow-up ]
    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.

  3. Change in pain-related disability [ Time Frame: Baseline, 3-month follow-up ]
    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.

  4. Change in Disease specific and generic health related quality of life (HRQOL) [ Time Frame: Baseline, 3-month follow-up ]
    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.

  5. Change in Medication use [ Time Frame: Baseline, 3-month follow-up ]
    Participants will record their medication use daily for 7 days at each assessment period

  6. Change in Pain self-efficacy [ Time Frame: Baseline, 3-month follow-up ]
    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

  7. Change in Psychological distress [ Time Frame: Baseline, 3-month follow-up ]
    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.

  8. Change in Sleep and Fatigue [ Time Frame: Baseline, 3-month follow-up ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322644


Contacts
Contact: Tonya M Palermo, PhD 2068844208 tonya.palermo@seattlechildrens.org

Sponsors and Collaborators
Seattle Children's Hospital
Mayo Clinic
University of Pittsburgh
Ohio State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Tonya M Palermo, PhD Seattle Children's Research Institute

Responsible Party: Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03322644     History of Changes
Other Study ID Numbers: Mayo IRB #17-007214
U01DK108334 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tonya Palermo, Seattle Children's Hospital:
Pancreatitis
Pain
Internet Intervention
Behavioral Intervention

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases