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Completed

NCT Number: NCT02367508

Mindfully Optimizing Delivery of End-of-Life Care

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.

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Key information

Conditions

Cancer Anxiety Disorders Behavior Behavioral Symptoms Coping Skills Depression Mental Disorders Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MODEL Care

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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).

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Charles Warren Fairbanks Center for Medical Ethics
  • Walther Cancer Institute

Registry information

Official study title

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

Acronym: MODEL Care

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Feb 20, 2015
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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