Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care)

July 27, 2016 updated by: Indiana University

Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care): Feasibility of a Synergistic Intervention for Patients, Family Caregivers, and Providers

The study evaluates the feasibility, acceptability, and preliminary efficacy of a mindfulness meditation-based intervention designed to provide a synergistic solution to the avoidant coping that often inhibits advance care planning discussions that are crucial to quality end-of-life care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Oncologists:

  • Be a physician specializing in medical oncology
  • Care for oncology patients at the affiliated cancer center
  • Have a patient panel that will allow for ≥6 eligible patients to be enrolled in the study
  • Be willing to attend the 5-session MODEL Care program for providers at the specified location, date, and time

Patients:

  • Adults ≥ 18 years of age
  • Receiving care from a medical oncologist enrolled in the study
  • Diagnosed with an incurable and advanced-stage solid malignancy (late stage III [B or C] or stage IV)
  • Have an attending medical oncologist who would not be surprised if the patient died in the next 12 months
  • Willing and able to travel to the class location for 6 weekly 2-hour sessions
  • Have a family member or friend eligible and interested in participating in the MODEL Care study
  • Able and willing to provide informed consent
  • Not have completed a Physician Orders for Scope of Treatment (POST) form

Family Caregivers:

  • Adults ≥18 years of age
  • Chosen by a family member or friend with cancer to join them in participating in the MODEL Care study
  • Willing and able to travel to the class location for 6 weekly 2-hour sessions
  • Able and willing to consent.

Exclusion Criteria:

Oncologists:

  • Planning to leave current practice setting for other employment in the next 3 months.

Patients:

  • Eastern Cooperative Oncology Group (ECOG) performance status of >2 or Karnofsky performance status <60 (suggesting patient is capable of only limited self-care, confined to bed or chair more than 50% of waking hours, or requires considerable assistance and frequent medical care) as rated by the attending oncologist
  • Currently receiving hospice care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MODEL Care
Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care) is a mindfulness meditation-based intervention to facilitate timely advance care planning (ACP) and end-of-life conversations with greater ease. Participants are taught a variety of mindfulness practices (e.g., breath awareness, sitting meditation, mindful movement through gentle yoga, and mindful communication) that can be used to enhance end-of-life coping.
Behavioral: MODEL Care
The Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care) intervention is two-pronged and mutually interactive with: (1) a patient and family caregiver group, and (2) an oncology provider group. Patients and family caregivers meet as a group for 6 weekly sessions of 2 hours each, for a total of 12 hours of class time. Oncology providers will have 5 class sessions for a total of 16 hours of class time. One class is held conjointly with patients, family caregivers, and providers to practice newly-learned skills. The course curriculum is generally based on mindfulness practices, group discussion, and didactic teaching with an emphasis on embodying interpersonal mindfulness in dialogue in daily life.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility: Recruitment Rates at Baseline
Time Frame: Recruitment rates will be estimated at baseline.
The number of individuals who are eligible will be divided by the number of individuals approached.
Recruitment rates will be estimated at baseline.
Feasibility: Enrollment Rates at Baseline
Time Frame: Enrollment rates will be caluclated at baseline.
The number of enrolled individuals will be divided by the number of eligible individuals.
Enrollment rates will be caluclated at baseline.
Feasibility: Attendance at Post-Intervention (6 weeks)
Time Frame: Attendance will be calculated at the end of the intervention (6 weeks).
The mean number of sessions attended by each participant type (i.e., patients, family caregivers, providers) will be calculated and compared to the total number of MODEL care sessions provided (i.e., 6 for patients/family caregivers and 5 for providers).
Attendance will be calculated at the end of the intervention (6 weeks).
Feasibility: Retention Rates at Post-Intervention (6 weeks)
Time Frame: Retention rates will be calculated at the end of the intervention (6 weeks).
The proportion of the total number of participants enrolled who completed post-intervention assessments (at 6 weeks) will be calculated by dividing the number of individuals assessed post-intervention (6 weeks) by the number of participants who were enrolled/assessed at baseline.
Retention rates will be calculated at the end of the intervention (6 weeks).
Acceptability: Intervention Satisfaction at Post-Intervention (6 weeks)
Time Frame: Participants' satisfaction with the intervention will be assessed at the end of the intervention (6 weeks).
An investigator-created measure of intervention satisfaction will be administered. This measure includes items assessing participants' overall satisfaction, satisfaction with different components of the intervention, likelihood of recommending the course to others, and the intention to continue using MODEL Care skills. The mean score on the satisfaction scale will be calculated for each group (patients, family caregivers, and providers) post-intervention (6 weeks).
Participants' satisfaction with the intervention will be assessed at the end of the intervention (6 weeks).
Feasibility: Retention Rates at 1-Month Follow-up (10 weeks)
Time Frame: Retention rates will be calculated at 1-month follow-up (10 weeks).
The proportion of the total number of participants enrolled who completed 1-month follow-up assessments (at 10 weeks) will be calculated by dividing the number of individuals who were assessed at 1-month follow-up (10 weeks) by the number of participants enrolled/assessed at baseline.
Retention rates will be calculated at 1-month follow-up (10 weeks).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Avoidant Coping at Post-Intervention (6 weeks)
Time Frame: Avoidant coping will be measured at baseline and post-intervention (6-weeks) for all three groups (patients, family caregivers, and health care providers).
To measure avoidant coping, the Brief COPE and Mini-Mental Adjustment to Cancer (Mini-MAC) scales will be administered to patients and family caregivers. To assess avoidance among participating health care providers, items adapted from a study assessing effects of end-of-life communication training, and 4 subscales from the Young-Rygh Avoidance Inventory will be used. The effects of MODEL Care on avoidant coping will be determined by calculating the change in avoidant coping scores from baseline to post-intervention (6 weeks) for each group of participants on their respective measures.
Avoidant coping will be measured at baseline and post-intervention (6-weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Avoidant Coping at 1-Month Follow-up (10 weeks)
Time Frame: Avoidant coping will be measured at baseline and at 1-month follow up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
To measure avoidant coping, the Brief COPE and Mini-Mental Adjustment to Cancer (Mini-MAC) scales will be administered to patients and family caregivers. To assess avoidance among participating health care providers, items adapted from a study assessing effects of end-of-life communication training and 4 subscales from the Young-Rygh Avoidance Inventory will be used. The effects of MODEL Care on avoidant coping will be determined by calculating the change in avoidant coping scores from baseline to 1-month follow-up for each group of participants on their respective measures.
Avoidant coping will be measured at baseline and at 1-month follow up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Quality of Life at Post-Intervention (6 weeks)
Time Frame: Quality of life will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Patients' quality of life will be measured with the McGill Quality of Life Inventory. Family caregivers' quality of life will be assessed with Caregiver Quality of Life Index-Cancer. Health care providers' quality of life will be assessed using the Professional Quality of Life measure, and Satisfaction with Life scale. The effects of MODEL Care on quality of life will be determined by calculating the change in quality of life scores from baseline to post-intervention (6 weeks) for each group of participants.
Quality of life will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Quality of Life at 1-Month Follow-up (10 weeks)
Time Frame: Quality of life will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Patients' quality of life will be measured with the McGill Quality of Life Inventory. Family caregivers' quality of life will be assessed with the Caregiver Quality of Life Index-Cancer. Health care providers' quality of life will be assessed using the Professional Quality of Life measure, and Satisfaction with Life scale. The effects of MODEL Care on quality of life will be determined by calculating the change in quality of life scores from baseline to 1-month follow up for each group of participants.
Quality of life will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Depression at Post-Intervention (6 weeks)
Time Frame: Depression will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Depression will be assessed for all 3 groups using the 8-item Patient Health Questionnaire depression scale (PHQ-8). The effects of MODEL Care on depression will be determined by calculating the change in PHQ-8 scores from baseline to post-intervention ( 6 weeks) for each group of participants.
Depression will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Depression at 1-Month Follow-up (10 weeks)
Time Frame: Depression will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Depression will be assessed for all 3 groups using the 8-item Patient Health Questionnaire depression scale (PHQ-8). The effects of MODEL Care on depression will be determined by calculating the change in PHQ-8 scores from baseline to 1-month follow up for each group of participants.
Depression will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Anxiety at Post-Intervention (6 weeks)
Time Frame: Anxiety will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Anxiety will be assessed for all 3 groups using the Generalized Anxiety Disorder scale (GAD-7). The effects of MODEL Care on anxiety will be determined by calculating the change in GAD-7 scores from baseline to post-intervention (6 weeks) for each group of participants.
Anxiety will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Anxiety at 1-Month Follow-up (10 weeks)
Time Frame: Anxiety will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Anxiety will be assessed for all 3 groups using the Generalized Anxiety Disorder scale (GAD-7). The effects of MODEL Care on anxiety will be determined by calculating the change in GAD-7 scores from baseline to 1-month follow up for each group of participants.
Anxiety will be measured at baseline and at 1-month follow-up (10 weeks) for all three groups (patients, family caregivers, and health care providers).
Change from Baseline in Readiness for Advance Care Planning at Post-Intervention (6 weeks)
Time Frame: Readiness for advance care planning will be measured at baseline and post-intervention (6 weeks) for patients only.
Patients' readiness to complete 3 advance care planning behaviors (i.e., Physician's Orders for Scope of Treatment form, discussing "goals of care" with their oncologist, and discussing "goals of care" with their family) will be assessed. Responses to these 3 items will indicate the patient's stage of readiness (ranging from pre-contemplation to maintenance) on each behavior. The effects of MODEL Care on advance care planning will be determined by calculating the change in readiness stage category on each behavior from baseline to post-intervention (6 weeks) for patients.
Readiness for advance care planning will be measured at baseline and post-intervention (6 weeks) for patients only.
Change from Baseline in Readiness for Advance Care Planning at 1-Month Follow-up (10 weeks)
Time Frame: Readiness for advance care planning will be measured at baseline and at 1-month follow-up (10 weeks) for patients only.
Patients' readiness to complete 3 advance care planning behaviors (i.e., Physician's Orders for Scope of Treatment form, discussing "goals of care" with their oncologist, and discussing "goals of care" with their family) will be assessed. Responses to these 3 items will indicate the patient's stage of readiness (ranging from pre-contemplation to maintenance) on each behavior. The effects of MODEL Care on advance care planning will be determined by calculating the change in readiness stage category on each behavior from baseline to 1-month follow-up for patients.
Readiness for advance care planning will be measured at baseline and at 1-month follow-up (10 weeks) for patients only.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Walther Cancer Institute
Charles Warren Fairbanks Center for Medical Ethics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shelley A. Johns, PsyD, Indiana University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1312088151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings