Mindfully Optimizing Delivery of End-of-Life Care

NCT ID: NCT02367508

Last Updated: 2016-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MODEL Care

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walther Cancer Institute

OTHER

Sponsor Role: collaborator

Charles Warren Fairbanks Center for Medical Ethics

UNKNOWN

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shelley A. Johns, PsyD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

References

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.

Reference Type: DERIVED

PMID: 31378080 (View on PubMed)

Other Identifiers

1312088151

Identifier Type: -

Identifier Source: org_study_id