Mindfully Optimizing Delivery of End-of-Life Care

Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367508
• Other study ID #: 1312088151
• Status: Completed
• Phase: N/A
• First received: December 31, 2014
• Last updated: July 27, 2016
• Start date: February 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indiana University Simon Cancer Center Scientific Review Committee, United States:Indiana University Institutional Review Board, United States:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Coping Skills

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Charles Warren Fairbanks Center for Medical Ethics, Walther Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Recruitment Rates 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.	No
Primary	Feasibility: Enrollment Rates at Baseline	The number of enrolled individuals will be divided by the number of eligible individuals.	Enrollment rates will be caluclated at baseline.	No
Primary	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).	Attendance will be calculated at the end of the intervention (6 weeks).	No
Primary	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.	Retention rates will be calculated at the end of the intervention (6 weeks).	No
Primary	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).	Participants' satisfaction with the intervention will be assessed at the end of the intervention (6 weeks).	No
Primary	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.	Retention rates will be calculated at 1-month follow-up (10 weeks).	No
Secondary	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.	Avoidant coping will be measured at baseline and post-intervention (6-weeks) for all three groups (patients, family caregivers, and health care providers).	No
Secondary	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.	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).	No
Secondary	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.	Quality of life will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).	No
Secondary	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.	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).	No
Secondary	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.	Depression will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).	No
Secondary	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.	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).	No
Secondary	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.	Anxiety will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).	No
Secondary	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.	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).	No
Secondary	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.	Readiness for advance care planning will be measured at baseline and post-intervention (6 weeks) for patients only.	No
Secondary	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.	Readiness for advance care planning will be measured at baseline and at 1-month follow-up (10 weeks) for patients only.	No