Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis

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Brief Title

Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis

Official Title

Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis

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.
    

Detailed Description

      Patients who meet diagnostic criteria for definite or suspected chronic pancreatitis and have
      current symptoms over the past month will be considered for study enrollment. Potential
      patients will be initially pre-screened by a patient chart review.

      If not excluded during the pre-screening process, potential subjects will be mailed
      questionnaires to fill out at home and speak with a member of the research team for an intake
      interview. At that time, they will be asked to sign a consent form after its review. Subjects
      will then be given instructions on how to participate in daily mindfulness therapy for
      one-month via the phone messaging service with a research team member.

      The total duration of the study intervention will be four weeks where enrolled patients will
      be asked to perform daily mindfulness sessions through our electronic mobile mindfulness
      therapy service.

      Patients will be sent a daily automated text message or call reminder to their mobile phone
      at a pre-determined time, selected by the patient at the intake interview. The text message
      will prompt patients with a phone number to call to access the Mindfulness Therapy sessions.

      When the patient is ready, s/he will call the provided phone number which is an automated
      answering and voice messaging service, which will prompt the patient to select a mindfulness
      therapy session of varying durations from 2 to 30 minutes. The session will lead the patients
      through deep relaxation breathing exercise for the duration the patient selected from the
      phone menu. Although the investigators will only ask patients to do one mindfulness session a
      day, patients are free to do as many as they want a day. At the end of their session,
      patients will leave a voice message with their name and current location such as home or
      work. The investigators will track the mindfulness sessions the individual patient
      participated in by obtaining their recorded voice messages in an inbox that correlates with
      the duration of the mindfulness session that the patient participated in. The voice messaging
      system will also provide information of the time the voice message was left, or time of
      completion of the patient's mindfulness session. If the patient prematurely terminated
      his/her session, got disconnected from his/her session or forgot to leave a message, the
      patient may call the same provided phone number to leave a message with his/her name, date of
      unrecorded session along with its duration and location of participation such as home or
      work.

      At the end of the study at four weeks, patients will be asked to complete an exit interview.
      The patient will be asked to fill out questionnaires during this interview. The patient will
      also be asked to participate in an informal exit interview with one of the research team
      members. Patients will be asked of any new medications were added during the duration of the
      study. They will also be asked regarding any changes in chronic pancreatitis strategies and
      any new stressors.
    


Study Type

Observational


Primary Outcome

Feasibility of a Mobile Mindfulness Therapy Application for Chronic Pancreatitis

Secondary Outcome

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

Condition

Pancreatitis, Chronic

Intervention

Mobile Mindfulness Therapy

Study Arms / Comparison Groups

 Definite/Suspected Chronic Pancreatitis
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

18

Start Date

August 2014

Completion Date

October 2015

Primary Completion Date

October 2015

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Walter Park, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02224898

Organization ID

IRB-30976


Responsible Party

Principal Investigator

Study Sponsor

Stanford University


Study Sponsor

Walter Park, MD, Principal Investigator, Stanford Hospital


Verification Date

November 2015