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 : Recruiting
First Posted : October 26, 2017
Last Update Posted : May 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis, Chronic Pancreatitis, Acute Recurrent||Behavioral: Internet-based CBT intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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)|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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.
- 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.
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
|Contact: Tonya M Palermo, PhDemail@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Mark Topazian, MD 507-266-4347 firstname.lastname@example.org|
|Contact: Vincent Anani, BA 507-266-4347 Anani.Vincent@mayo.edu|
|Principal Investigator:||Tonya M Palermo, PhD||Seattle Children's Research Institute|