Mindfully Optimizing Delivery of End-of-Life Care

NCT02367508 | Completed DMC

• 1 other identifier: 1312088151
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• 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).

• 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).

• 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).

• 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).

Secondary Outcomes (10)

• Change from Baseline in Avoidant Coping at Post-Intervention (6 weeks)

  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)

  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)

  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)

  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)

  Depression will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).

Study Arms (1)

MODEL Care

EXPERIMENTAL

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

Interventions

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.

MODEL Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Walther Cancer Institute: collaborator
• Charles Warren Fairbanks Center for Medical Ethics: collaborator

Related Publications (1)

• 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.

  PMID: 31378080 DERIVED

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Shelley A. Johns, PsyD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: February 20, 2015
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2015
• Last Updated: July 28, 2016

Record last verified: 2016-07