Back to resultsMindfully Optimizing Delivery of End-of-Life Care (MODEL Care)
Primary Purpose
Cancer, Coping Skills
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MODEL Care
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring advance care planning, coping skills, mindfulness, meditation, cancer, adult, caregivers, oncology providers, advance directives, anxiety, depression, quality of life, pilot project
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MODEL Care
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility: Recruitment Rates at Baseline
The number of individuals who are eligible will be divided by the number of individuals approached.
Feasibility: Enrollment Rates at Baseline
The number of enrolled individuals will be divided by the number of eligible individuals.
Feasibility: Attendance at Post-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).
Feasibility: Retention Rates at Post-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.
Acceptability: Intervention Satisfaction at Post-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).
Feasibility: Retention Rates 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.
Secondary Outcome Measures
Change from Baseline in Avoidant Coping at Post-Intervention (6 weeks)
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.
Change from Baseline in Avoidant Coping at 1-Month Follow-up (10 weeks)
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.
Change from Baseline in Quality of Life at Post-Intervention (6 weeks)
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.
Change from Baseline in Quality of Life at 1-Month Follow-up (10 weeks)
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.
Change from Baseline in Depression at Post-Intervention (6 weeks)
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.
Change from Baseline in Depression at 1-Month Follow-up (10 weeks)
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.
Change from Baseline in Anxiety at Post-Intervention (6 weeks)
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.
Change from Baseline in Anxiety at 1-Month Follow-up (10 weeks)
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.
Change from Baseline in Readiness for Advance Care Planning at Post-Intervention (6 weeks)
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.
Change from Baseline in Readiness for Advance Care Planning at 1-Month Follow-up (10 weeks)
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.
Full Information
NCT ID
NCT02367508
First Posted
December 31, 2014
Last Updated
July 27, 2016
Sponsor
Indiana University
Collaborators
Walther Cancer Institute, Charles Warren Fairbanks Center for Medical Ethics
1. Study Identification
Unique Protocol Identification Number
NCT02367508
Brief Title
Mindfully Optimizing Delivery of End-of-Life Care
Acronym
MODEL Care
Official Title
Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care): Feasibility of a Synergistic Intervention for Patients, Family Caregivers, and Providers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
Walther Cancer Institute, Charles Warren Fairbanks Center for Medical Ethics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Coping Skills
Keywords
advance care planning, coping skills, mindfulness, meditation, cancer, adult, caregivers, oncology providers, advance directives, anxiety, depression, quality of life, pilot project
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MODEL Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MODEL Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility: Recruitment Rates at Baseline
Description
The number of individuals who are eligible will be divided by the number of individuals approached.
Time Frame
Recruitment rates will be estimated at baseline.
Title
Feasibility: Enrollment Rates at Baseline
Description
The number of enrolled individuals will be divided by the number of eligible individuals.
Time Frame
Enrollment rates will be caluclated at baseline.
Title
Feasibility: Attendance at Post-Intervention (6 weeks)
Description
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).
Time Frame
Attendance will be calculated at the end of the intervention (6 weeks).
Title
Feasibility: Retention Rates at Post-Intervention (6 weeks)
Description
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.
Time Frame
Retention rates will be calculated at the end of the intervention (6 weeks).
Title
Acceptability: Intervention Satisfaction at Post-Intervention (6 weeks)
Description
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).
Time Frame
Participants' satisfaction with the intervention will be assessed at the end of the intervention (6 weeks).
Title
Feasibility: Retention Rates at 1-Month Follow-up (10 weeks)
Description
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.
Time Frame
Retention rates will be calculated at 1-month follow-up (10 weeks).
Secondary Outcome Measure Information:
Title
Change from Baseline in Avoidant Coping at Post-Intervention (6 weeks)
Description
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.
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).
Title
Change from Baseline in Avoidant Coping at 1-Month Follow-up (10 weeks)
Description
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.
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).
Title
Change from Baseline in Quality of Life at Post-Intervention (6 weeks)
Description
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.
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).
Title
Change from Baseline in Quality of Life at 1-Month Follow-up (10 weeks)
Description
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.
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).
Title
Change from Baseline in Depression at Post-Intervention (6 weeks)
Description
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.
Time Frame
Depression will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Title
Change from Baseline in Depression at 1-Month Follow-up (10 weeks)
Description
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.
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).
Title
Change from Baseline in Anxiety at Post-Intervention (6 weeks)
Description
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.
Time Frame
Anxiety will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
Title
Change from Baseline in Anxiety at 1-Month Follow-up (10 weeks)
Description
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.
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).
Title
Change from Baseline in Readiness for Advance Care Planning at Post-Intervention (6 weeks)
Description
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.
Time Frame
Readiness for advance care planning will be measured at baseline and post-intervention (6 weeks) for patients only.
Title
Change from Baseline in Readiness for Advance Care Planning at 1-Month Follow-up (10 weeks)
Description
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.
Time Frame
Readiness for advance care planning will be measured at baseline and at 1-month follow-up (10 weeks) for patients only.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelley A. Johns, PsyD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
31378080
Citation
Johns SA, Beck-Coon K, Stutz PV, Talib TL, Chinh K, Cottingham AH, Schmidt K, Shields C, Stout ME, Stump TE, Monahan PO, Torke AM, Helft PR. Mindfulness Training Supports Quality of Life and Advance Care Planning in Adults With Metastatic Cancer and Their Caregivers: Results of a Pilot Study. Am J Hosp Palliat Care. 2020 Feb;37(2):88-99. doi: 10.1177/1049909119862254. Epub 2019 Aug 4.
Results Reference
derived
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Mindfully Optimizing Delivery of End-of-Life Care
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