Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis

NCT02224898 | Completed DMC

• 1 other identifier: IRB-30976
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The research objective of this pilot study is to test the feasibility of a mobile electronic mindfulness therapy service for patients with definite or suspected chronic pancreatitis. A secondary aim will be to determine the effect of the intervention on a symptom severity/global assessment of improvement for patients with chronic pancreatitis. The investigators hypothesize that a one-month period of daily mindfulness therapy delivered via a phone messaging service will reduce symptoms.

Conditions

Pancreatitis, Chronic

Outcome Measures

Primary Outcomes (1)

• Feasibility of a Mobile Mindfulness Therapy Application for Chronic Pancreatitis

  The primary outcome will measure daily compliance rates with the denominator being 30 days and the numerator equal to the number of days out of 30 that the patient used the mobile mindfulness therapy application.

  1 month

Secondary Outcomes (1)

• The effect of mobile mindfulness therapy on a symptom severity/global assessment of improvement for patients with definite or suspected chronic pancreatitis

  1 month

Study Arms (2)

Definite/Suspected Chronic Pancreatitis

Patients with diagnosis of chronic pancreatitis with at least two of the following features: clinical course consistent with chronic pancreatitis, calcification in the pancreas on US/CT/EUS, ERCP showing ductal abnormalities (Cambridge Classification), exocrine insufficiency, histology showing irregular fibrosis, acinar cell loss, islet cell loss, and inflammatory cell infiltrates, or other features suggestive of chronic pancreatitis (such as pancreatic pseudocyst). The study group will also include patients with suspected chronic pancreatitis based on history of documented pancreatitis with lingering symptoms or signs of early chronic pancreatitis on imaging. Subjects will be asked to complete 30 days of mobile mindfulness therapy, for 2-30 minutes daily.

Behavioral: Mobile Mindfulness Therapy

Healthy Control Group

Patients with no history of chronic gastrointestinal symptoms lasting greater than 8 weeks, no gastrointestinal disease or condition diagnosis, and are not currently experiencing gastrointestinal symptoms. Subjects will be asked to complete 30 days of mobile mindfulness therapy, for 2-30 minutes daily.

Behavioral: Mobile Mindfulness Therapy

Interventions

Mobile Mindfulness Therapy BEHAVIORAL

Subjects will be asked to complete 30 days of mobile mindfulness therapy, for 2-30 minutes daily.

Definite/Suspected Chronic Pancreatitis; Healthy Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit a minimum of 10 and maximum of 40 subjects diagnosed with chronic pancreatitis and 5 healthy control subjects with no past or present chronic gastrointestinal symptoms lasting greater than 8 weeks, no chronic medical conditions and no organic gastrointestinal disease. All patients with suspected/definite chronic pancreatitis will be associated with Stanford Hospital and Clinics and the 5 healthy controls may or may not be associated with Stanford.

You may qualify if:

• For the study group: Patients with diagnosis of chronic pancreatitis with at least two of the following features: clinical course consistent with chronic pancreatitis, calcification in the pancreas on US/CT/EUS, ERCP showing ductal abnormalities (Cambridge Classification), exocrine insufficiency, histology showing irregular fibrosis, acinar cell loss, islet cell loss, and inflammatory cell infiltrates, or other features suggestive of chronic pancreatitis (such as pancreatic pseudocyst). The study group will also include patients with suspected chronic pancreatitis based on history of documented pancreatitis with lingering symptoms or signs of early chronic pancreatitis on imaging.
• For the control group: no history of chronic GI symptoms lasting greater than 8 weeks, no gastrointestinal disease or condition diagnosis, and not be currently experiencing gastrointestinal symptoms.
• Age 18 to 80
• Willing to give informed consent
• Able to complete entire study
• Ability to speak and read English
• Regular menstrual cycles or menopause for at least 6 months
• Owns a mobile phone with texting capabilities
• Unlimited minutes and text messaging dataplan for mobile phone
• Physically and mentally capable of using a mobile phone
• Phone access

You may not qualify if:

• Red flags of concern: anemia, blood in stools, unexplained weight loss, unexplained fevers
• Pregnant or nursing woman, or planning on becoming pregnant within next year
• Travel plans outside of the county over the study duration or a month prior
• Change in medications one month prior or during study
• Change in chronic pancreatitis management strategies one month prior or during study such as dietary changes, exercise, counseling and behavioral therapies.
• Current co-morbid condition that might account for GI symptoms
• Current infectious diseases: HIV, Hepatitis A, B or C, other
• Psychiatric Conditions: moderate to severe depression (ECT, unable to work, disrupts ADL's), moderate to severe anxiety (unable to work, disrupts ADL's), bipolar disorder, schizophrenia, or history of psychosis, suicidal ideation or attempt, substance abuse (alcohol and/or drugs in past year), dissociative disorder, dementia related disorder
• Immunologic Diseases: systemic lupus, moderate to severe arthritis, scleroderma, other
• Gastrointestinal Disorders: inflammatory bowel diseases (ulcerative colitis, Crohn's), celiac disease,personal history of colon cancer or polyps, other unless condition associated with chronic pancreatitis.
• Cardiovascular disorder, clinically significant in past 12 months
• Pain disorder, clinically significant (back pain, fibromyalgia)
• Recent surgery, during 6 months prior to study enrollment or during study period (except minor surgeries such as wisdom teeth extraction, cataract surgery, corrective lens surgery, and/or minor skin surgeries)
• Major stressor(s) in life 3 months prior to study or anticipated over the next month

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Walter Park, MD

  Stanford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 25, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

US (1)