<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02224898</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-30976</org_study_id>
    <nct_id>NCT02224898</nct_id>
  </id_info>
  <brief_title>Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis</brief_title>
  <official_title>Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The research objective of this pilot study is to test the feasibility of a mobile electronic&#xD;
      mindfulness therapy service for patients with definite or suspected chronic pancreatitis.&#xD;
&#xD;
      A secondary aim will be to determine the effect of the intervention on a symptom&#xD;
      severity/global assessment of improvement for patients with chronic pancreatitis. The&#xD;
      investigators hypothesize that a one-month period of daily mindfulness therapy delivered via&#xD;
      a phone messaging service will reduce symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who meet diagnostic criteria for definite or suspected chronic pancreatitis and have&#xD;
      current symptoms over the past month will be considered for study enrollment. Potential&#xD;
      patients will be initially pre-screened by a patient chart review.&#xD;
&#xD;
      If not excluded during the pre-screening process, potential subjects will be mailed&#xD;
      questionnaires to fill out at home and speak with a member of the research team for an intake&#xD;
      interview. At that time, they will be asked to sign a consent form after its review. Subjects&#xD;
      will then be given instructions on how to participate in daily mindfulness therapy for&#xD;
      one-month via the phone messaging service with a research team member.&#xD;
&#xD;
      The total duration of the study intervention will be four weeks where enrolled patients will&#xD;
      be asked to perform daily mindfulness sessions through our electronic mobile mindfulness&#xD;
      therapy service.&#xD;
&#xD;
      Patients will be sent a daily automated text message or call reminder to their mobile phone&#xD;
      at a pre-determined time, selected by the patient at the intake interview. The text message&#xD;
      will prompt patients with a phone number to call to access the Mindfulness Therapy sessions.&#xD;
&#xD;
      When the patient is ready, s/he will call the provided phone number which is an automated&#xD;
      answering and voice messaging service, which will prompt the patient to select a mindfulness&#xD;
      therapy session of varying durations from 2 to 30 minutes. The session will lead the patients&#xD;
      through deep relaxation breathing exercise for the duration the patient selected from the&#xD;
      phone menu. Although the investigators will only ask patients to do one mindfulness session a&#xD;
      day, patients are free to do as many as they want a day. At the end of their session,&#xD;
      patients will leave a voice message with their name and current location such as home or&#xD;
      work. The investigators will track the mindfulness sessions the individual patient&#xD;
      participated in by obtaining their recorded voice messages in an inbox that correlates with&#xD;
      the duration of the mindfulness session that the patient participated in. The voice messaging&#xD;
      system will also provide information of the time the voice message was left, or time of&#xD;
      completion of the patient's mindfulness session. If the patient prematurely terminated&#xD;
      his/her session, got disconnected from his/her session or forgot to leave a message, the&#xD;
      patient may call the same provided phone number to leave a message with his/her name, date of&#xD;
      unrecorded session along with its duration and location of participation such as home or&#xD;
      work.&#xD;
&#xD;
      At the end of the study at four weeks, patients will be asked to complete an exit interview.&#xD;
      The patient will be asked to fill out questionnaires during this interview. The patient will&#xD;
      also be asked to participate in an informal exit interview with one of the research team&#xD;
      members. Patients will be asked of any new medications were added during the duration of the&#xD;
      study. They will also be asked regarding any changes in chronic pancreatitis strategies and&#xD;
      any new stressors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of a Mobile Mindfulness Therapy Application for Chronic Pancreatitis</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effect of mobile mindfulness therapy on a symptom severity/global assessment of improvement for patients with definite or suspected chronic pancreatitis</measure>
    <time_frame>1 month</time_frame>
    <description>After consent to participate, the patient will complete a set of quality of life instruments before participating in the mindfulness therapy sessions. After 30 days, the patient will repeat completing the set of quality of life instruments. These include the SF-36, PANQOLI, and specific PROMIS QoL instruments.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Pancreatitis, Chronic</condition>
  <arm_group>
    <arm_group_label>Definite/Suspected Chronic Pancreatitis</arm_group_label>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control Group</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile Mindfulness Therapy</intervention_name>
    <description>Subjects will be asked to complete 30 days of mobile mindfulness therapy, for 2-30 minutes daily.</description>
    <arm_group_label>Definite/Suspected Chronic Pancreatitis</arm_group_label>
    <arm_group_label>Healthy Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will recruit a minimum of 10 and maximum of 40 subjects diagnosed with chronic&#xD;
        pancreatitis and 5 healthy control subjects with no past or present chronic&#xD;
        gastrointestinal symptoms lasting greater than 8 weeks, no chronic medical conditions and&#xD;
        no organic gastrointestinal disease. All patients with suspected/definite chronic&#xD;
        pancreatitis will be associated with Stanford Hospital and Clinics and the 5 healthy&#xD;
        controls may or may not be associated with Stanford.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For the study group: Patients with diagnosis of chronic pancreatitis with at least two&#xD;
             of the following features: clinical course consistent with chronic pancreatitis,&#xD;
             calcification in the pancreas on US/CT/EUS, ERCP showing ductal abnormalities&#xD;
             (Cambridge Classification), exocrine insufficiency, histology showing irregular&#xD;
             fibrosis, acinar cell loss, islet cell loss, and inflammatory cell infiltrates, or&#xD;
             other features suggestive of chronic pancreatitis (such as pancreatic pseudocyst). The&#xD;
             study group will also include patients with suspected chronic pancreatitis based on&#xD;
             history of documented pancreatitis with lingering symptoms or signs of early chronic&#xD;
             pancreatitis on imaging.&#xD;
&#xD;
          -  For the control group: no history of chronic GI symptoms lasting greater than 8 weeks,&#xD;
             no gastrointestinal disease or condition diagnosis, and not be currently experiencing&#xD;
             gastrointestinal symptoms.&#xD;
&#xD;
          -  Age 18 to 80&#xD;
&#xD;
          -  Willing to give informed consent&#xD;
&#xD;
          -  Able to complete entire study&#xD;
&#xD;
          -  Ability to speak and read English&#xD;
&#xD;
          -  Regular menstrual cycles or menopause for at least 6 months&#xD;
&#xD;
          -  Owns a mobile phone with texting capabilities&#xD;
&#xD;
          -  Unlimited minutes and text messaging dataplan for mobile phone&#xD;
&#xD;
          -  Physically and mentally capable of using a mobile phone&#xD;
&#xD;
          -  Phone access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Red flags of concern: anemia, blood in stools, unexplained weight loss, unexplained&#xD;
             fevers&#xD;
&#xD;
          -  Pregnant or nursing woman, or planning on becoming pregnant within next year&#xD;
&#xD;
          -  Travel plans outside of the county over the study duration or a month prior&#xD;
&#xD;
          -  Change in medications one month prior or during study&#xD;
&#xD;
          -  Change in chronic pancreatitis management strategies one month prior or during study&#xD;
             such as dietary changes, exercise, counseling and behavioral therapies.&#xD;
&#xD;
          -  Current co-morbid condition that might account for GI symptoms&#xD;
&#xD;
          -  Current infectious diseases: HIV, Hepatitis A, B or C, other&#xD;
&#xD;
          -  Psychiatric Conditions: moderate to severe depression (ECT, unable to work, disrupts&#xD;
             ADL's), moderate to severe anxiety (unable to work, disrupts ADL's), bipolar disorder,&#xD;
             schizophrenia, or history of psychosis, suicidal ideation or attempt, substance abuse&#xD;
             (alcohol and/or drugs in past year), dissociative disorder, dementia related disorder&#xD;
&#xD;
          -  Immunologic Diseases: systemic lupus, moderate to severe arthritis, scleroderma, other&#xD;
&#xD;
          -  Gastrointestinal Disorders: inflammatory bowel diseases (ulcerative colitis, Crohn's),&#xD;
             celiac disease,personal history of colon cancer or polyps, other unless condition&#xD;
             associated with chronic pancreatitis.&#xD;
&#xD;
          -  Cardiovascular disorder, clinically significant in past 12 months&#xD;
&#xD;
          -  Pain disorder, clinically significant (back pain, fibromyalgia)&#xD;
&#xD;
          -  Recent surgery, during 6 months prior to study enrollment or during study period&#xD;
             (except minor surgeries such as wisdom teeth extraction, cataract surgery, corrective&#xD;
             lens surgery, and/or minor skin surgeries)&#xD;
&#xD;
          -  Major stressor(s) in life 3 months prior to study or anticipated over the next month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Walter Park, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Hospital and Clinics</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>November 16, 2015</last_update_submitted>
  <last_update_submitted_qc>November 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Walter G. Park, M.D., M.S.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224898
org study id: IRB-30976
nct id: NCT02224898
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: Feasibility of a Mobile Mindfulness Therapy Application for Chronic Pancreatitis
time frame: 1 month
description: 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.
measure: The effect of mobile mindfulness therapy on a symptom severity/global assessment of improvement for patients with definite or suspected chronic pancreatitis
time frame: 1 month
description: After consent to participate, the patient will complete a set of quality of life instruments before participating in the mindfulness therapy sessions. After 30 days, the patient will repeat completing the set of quality of life instruments. These include the SF-36, PANQOLI, and specific PROMIS QoL instruments.
arm group label: 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.
arm group label: Healthy Control Group
description: 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.
intervention type: Behavioral
intervention name: Mobile Mindfulness Therapy
description: Subjects will be asked to complete 30 days of mobile mindfulness therapy, for 2-30 minutes daily.
arm group label: Definite/Suspected Chronic Pancreatitis
arm group label: Healthy Control Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Walter Park, MD
role: Principal Investigator
affiliation: Stanford Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Walter G. Park, M.D., M.S.
investigator title: Principal Investigator
mesh term: Pancreatitis
mesh term: Pancreatitis, Chronic