Liver DiseasesNCT04255082
Mindfulness and Shared Decision Making
An observational study of Liver Diseases, run by Methodist Health System at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of mindfulness-based interventions on patient stress, patient-provider communication, and other measures of SDM at MDMC. There is a need to have a quantifiable measure of perceived stress and communication ability in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- assess the impact of mindfulness-based interventions on inpatients' and outpatients' stress, patient-provider communication, and other measures of SDM at MDMC.
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 20 Jul 2022
- How long will I take part?
- 7 Days
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients at MDMC, The Liver Institute, and Texas Oncology between 6/1/2018 and 12/31/2020.
Who may be able to join
- Age 18 years or older
- Inpatients and outpatients receiving treatment at MDMC, the Liver Institute, or Texas Oncology
- Provided written informed consent
Who cannot join
- Below 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
The Liver Institute at Methodist Dallas Medical Center
Irving, Texas, 75603
About this study
The purpose of this study is to assess the impact of mindfulness-based interventions on patient stress, patient-provider communication, and other measures of SDM at MDMC.
There is a need to have a quantifiable measure of perceived stress and communication ability in patients. This is the first study of its kind to be conducted at MDMC. This pilot study will not only benefit the patients but also contribute to the medical community's understanding of treating the whole patient through mindfulness and shared decision making.
Read more
2.1. Study Objectives 2.1.1. Primary Objective To assess the impact of mindfulness-based interventions on inpatients and outpatients stress, patient-provider communication, and other measures of SDM at MDMC.
2.1.2. Secondary Objectives To evaluate the feasibility of such a study in the patient population.
Read the detailed description
This will be a prospective cohort of patients at MDMC, The Liver Institute, and Texas Oncology between 6/1/2018 and 12/31/2020. Subject records will be reviewed to identify case-based details including demographics, diagnosis, and date of diagnosis. Subjects will complete survey instruments to assess their levels of stress and anxiety, and the impact of the same on their ability to communicate at baseline, after the stress management coaching session, following their treatment planning visit (outpatients only), and one week after the visit (by mail). Providers will also complete the dyadic OPTION instrument (for outpatients only) to empirically assess the perceived degree of patient involvement in the treatment planning process. The face-to-face stress management coaching session will occur approximately an hour before meeting with the treatment planning team for outpatients and at a designated time identified for inpatients. The session will focus on mindfulness-based interventions on stress regulation, communication, and shared decision making. A comprehensive evaluation will be performed and a unique treatment plan developed for each subject based on a biopsychosocial model to address the mind, body, and spirit. Nutritional counseling and lifestyle coaching will also be addressed.
2.2. Study Outcome Measures 2.2.1. Primary Outcome
The effectiveness of the mindfulness-based intervention which will be assessed by:
Baseline and post-intervention perception of stress and anxiety Impact of stress on communication Emotional-Brain state Level of SDM during a pivotal visit with provider e.g. treatment planning visit (for outpatients only) The Emotional Distress-Anxiety (PROMIS, 2016), Communication Short Form (Cella, PROMIS, 2013), Emotional/Brain State Question (Mellin, 2017) and The Shared Decision Making dyadic OPTION scale (Melbourne, 2016) will be used to evaluate these outcomes.
2.2.2. Secondary Outcome Feasibility of such a study in the patient population and setting. This will be measured by the barriers encountered and the ability to successfully carry out the study.
2.3 Study Enrollment: 2.3.1.Study Inclusion Criteria
- Age 18 years or olde
- Newly diagnosed cancer patient (breast, pancreatic, head \& neck, hepatocellular carcinoma, cholangiocarcinoma, and colorectal carcinoma with metastases to the liver) at MDMC, the Liver Institute, or Texas Oncology
- Provided written informed consent 2.3.2. Study Exclusion Criteria
- Below 18 years of age
- Does not have cancer
- Conditions
- Liver Diseases
- Being tested
- assess the impact of mindfulness-based interventions on inpatients' and outpatients' stress, patient-provider communication, and other measures of SDM at MDMC.
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assess the impact of mindfulness-based interventions on inpatients' and outpatients' stress, patient-provider communication, and other measures of SDM at MDMC.Other
Effectiveness of the mindfulness-based intervention which will be assessed by:
Baseline and post-intervention perception of stress and anxiety Impact of stress on communication Emotional/Brain state Level of SDM during a pivotal visit with provider e.g. treatment planning visit (for outpatients only) The Emotional Distress-Anxiety (PROMIS, 2016), Communication Short Form (Cella, PROMIS, 2013), Emotional/Brain State Question (Mellin, 2017) and The Shared Decision Making dyadic OPTION scale (Melbourne, 2016) will be used to evaluate these outcomes.
Feasibility of such a study in the patient population and setting. This will be measured by the barriers encountered and the ability to successfully carry out the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline and post-intervention perception of stress & anxiety by answering survey questions
Effectiveness of the mindfulness-based intervention which will be assessed by survey questions:
Baseline and post-intervention perception of stress and anxiety t of stress on communication Emotional/Brain state Level of SDM during a pivotal visit with provider e.g. treatment planning visit (for outpatients only) The Emotional Distress-Anxiety (PROMIS, 2016).
Measured: 6/1/2018 and 12/31/2020
Secondary outcomes (1)
Feasibility of a study in the patient population and setting by any difficulties faced during the study phase
Feasibility of such a study in the patient population and setting. This will be measured by the barriers encountered and the ability to successfully carry out the study. The study questionnaire will be used for the subjects.
Measured: 6/1/2018 and 12/31/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Aug 2018
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parvez Mantry, M.D., Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255082
- Sponsor's protocol ID
- 030.HEP.2018.D
- Status last verified
- Sep 2022
- First submitted
- 3 Apr 2019
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Shared Decision Making
- ClinicalTrials.gov ID
- NCT04255082
- Acronym / sponsor ID
- 030.HEP.2018.D
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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 purpose of this study is to assess the impact of mindfulness-based interventions on patient stress, patient-provider communication, and other measures of SDM at MDMC.
There is a need to have a quantifiable measure of perceived stress and communication ability in patients. This is the first study of its kind to be conducted at MDMC. This pilot study will not only benefit the patients but also contribute to the medical community's understanding of treating the whole patient through mindfulness and shared decision making.
2.1. Study Objectives 2.1.1. Primary Objective To assess the impact of mindfulness-based interventions on inpatients and outpatients stress, patient-provider communication, and other measures of SDM at MDMC.
2.1.2. Secondary Objectives To evaluate the feasibility of such a study in the patient population.
Detailed description
This will be a prospective cohort of patients at MDMC, The Liver Institute, and Texas Oncology between 6/1/2018 and 12/31/2020. Subject records will be reviewed to identify case-based details including demographics, diagnosis, and date of diagnosis. Subjects will complete survey instruments to assess their levels of stress and anxiety, and the impact of the same on their ability to communicate at baseline, after the stress management coaching session, following their treatment planning visit (outpatients only), and one week after the visit (by mail). Providers will also complete the dyadic OPTION instrument (for outpatients only) to empirically assess the perceived degree of patient involvement in the treatment planning process. The face-to-face stress management coaching session will occur approximately an hour before meeting with the treatment planning team for outpatients and at a designated time identified for inpatients. The session will focus on mindfulness-based interventions on stress regulation, communication, and shared decision making. A comprehensive evaluation will be performed and a unique treatment plan developed for each subject based on a biopsychosocial model to address the mind, body, and spirit. Nutritional counseling and lifestyle coaching will also be addressed.
2.2. Study Outcome Measures 2.2.1. Primary Outcome
The effectiveness of the mindfulness-based intervention which will be assessed by:
Baseline and post-intervention perception of stress and anxiety Impact of stress on communication Emotional-Brain state Level of SDM during a pivotal visit with provider e.g. treatment planning visit (for outpatients only) The Emotional Distress-Anxiety (PROMIS, 2016), Communication Short Form (Cella, PROMIS, 2013), Emotional/Brain State Question (Mellin, 2017) and The Shared Decision Making dyadic OPTION scale (Melbourne, 2016) will be used to evaluate these outcomes.
2.2.2. Secondary Outcome Feasibility of such a study in the patient population and setting. This will be measured by the barriers encountered and the ability to successfully carry out the study.
2.3 Study Enrollment: 2.3.1.Study Inclusion Criteria
- Age 18 years or olde
- Newly diagnosed cancer patient (breast, pancreatic, head \& neck, hepatocellular carcinoma, cholangiocarcinoma, and colorectal carcinoma with metastases to the liver) at MDMC, the Liver Institute, or Texas Oncology
- Provided written informed consent 2.3.2. Study Exclusion Criteria
- Below 18 years of age
- Does not have cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients at MDMC, The Liver Institute, and Texas Oncology between 6/1/2018 and 12/31/2020.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Inpatients and outpatients receiving treatment at MDMC, the Liver Institute, or Texas Oncology
- Provided written informed consent
Key exclusion criteria (1 listed)
- Below 18 years of age
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 |
|---|---|---|
| assess the impact of mindfulness-based interventions on inpatients' and outpatients' stress, patient-provider communication, and other measures of SDM at MDMC.Effectiveness of the mindfulness-based intervention which will be assessed by: Baseline and post-intervention perception of stress and anxiety Impact of stress on communication Emotional/Brain state Level of SDM during a pivotal visit with provider e.g. treatment planning visit (for outpatients only) The Emotional Distress-Anxiety (PROMIS, 2016), Communication Short Form (Cella, PROMIS, 2013), Emotional/Brain State Question (Mellin, 2017) and The Shared Decision Making dyadic OPTION scale (Melbourne, 2016) will be used to evaluate these outcomes. Feasibility of such a study in the patient population and setting. This will be measured by the barriers encountered and the ability to successfully carry out the study. | Other | – |
Primary outcome
Baseline and post-intervention perception of stress & anxiety by answering survey questions
Time frame: 6/1/2018 and 12/31/2020
Effectiveness of the mindfulness-based intervention which will be assessed by survey questions: Baseline and post-intervention perception of stress and anxiety t of stress on communication Emotional/Brain state Level of SDM during a pivotal visit with provider e.g. treatment planning visit (for outpatients only) The Emotional Distress-Anxiety (PROMIS, 2016).
1 secondary outcome
Feasibility of a study in the patient population and setting by any difficulties faced during the study phase
Time frame: 6/1/2018 and 12/31/2020
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 23 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Parvez Mantry, M.D. principal investigator
Methodist Health System
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 Liver Diseases, run by Methodist Health System 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 3 inclusion and 1 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 23 Mar 2026. 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?
Baseline and post-intervention perception of stress & anxiety by answering survey questions (time frame: 6/1/2018 and 12/31/2020). 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 23 Mar 2026.