Pancreatitis, ChronicNCT02224898
Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis
An observational study of Pancreatitis, Chronic, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatitis, Chronic
- What is being tested?
- Mobile Mindfulness Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Palo Alto, California, 94305
About this study
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.
Read the 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.
- Conditions
- Pancreatitis, Chronic
- Being tested
- Mobile Mindfulness Therapy
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Mindfulness TherapyBehavioural
Subjects will be asked to complete 30 days of mobile mindfulness therapy, for 2-30 minutes daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mobile Mindfulness Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, ChronicStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter G. Park, M.D., M.S., Stanford University
- Investigators
- Walter Park, MD, Principal investigator, Stanford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224898
- Sponsor's protocol ID
- IRB-30976
- Status last verified
- Nov 2015
- First submitted
- 20 Aug 2014
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT02224898
- Acronym / sponsor ID
- IRB-30976
- Conditions
- Pancreatitis, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Definite/Suspected Chronic Pancreatitis | – | Behavioral: Mobile Mindfulness TherapyPatients 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. |
| Healthy Control Group | – | Behavioral: Mobile Mindfulness TherapyPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Mindfulness TherapySubjects will be asked to complete 30 days of mobile mindfulness therapy, for 2-30 minutes daily. | Behavioural | Definite/Suspected Chronic Pancreatitis, Healthy Control Group |
Primary outcome
Feasibility of a Mobile Mindfulness Therapy Application for Chronic Pancreatitis
Time frame: 1 month
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 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Park, MD principal investigator
Stanford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, Chronic, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a Mobile Mindfulness Therapy Application for Chronic Pancreatitis (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.