- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02367508
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
Study Type
Interventional
Enrollment (Actual)
31
Phase
- 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
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 |
Intervention / Treatment |
---|---|
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.
|
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
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
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
Investigators
- 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.
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
February 1, 2014
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
December 31, 2014
First Submitted That Met QC Criteria
February 13, 2015
First Posted (Estimate)
February 20, 2015
Study Record Updates
Last Update Posted (Estimate)
July 28, 2016
Last Update Submitted That Met QC Criteria
July 27, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
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