Mindfulness and Shared Decision Making

Liver Diseases Clinical Trial

Official title:

Mindfulness and Shared Decision Making

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255082
• Other study ID #: 030.HEP.2018.D
• Status: Completed
• Start date: August 15, 2018
• Est. completion date: July 20, 2022

Study information

• Verified date: September 2022
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 20, 2022
• Est. primary completion date: July 20, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Inpatients and outpatients receiving treatment at MDMC, the Liver Institute, or Texas Oncology

• Provided written informed consent

Exclusion Criteria:

• Below 18 years of age

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	The Liver Institute at Methodist Dallas Medical Center	Irving	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6/1/2018 and 12/31/2020
Secondary	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.	6/1/2018 and 12/31/2020