Clinical trial NCT02367508: Mindfully Optimizing Delivery of End-of-Life 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Walther Cancer Institute
name: Charles Warren Fairbanks Center for Medical Ethics
First posted: 2015-02-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Feasibility: Recruitment Rates at Baseline
timeFrame: Recruitment rates will be estimated at baseline.
measure: Feasibility: Enrollment Rates at Baseline
timeFrame: Enrollment rates will be caluclated at baseline.
measure: Feasibility: Attendance at Post-Intervention (6 weeks)
timeFrame: Attendance will be calculated at the end of the intervention (6 weeks).
measure: Feasibility: Retention Rates at Post-Intervention (6 weeks)
timeFrame: Retention rates will be calculated at the end of the intervention (6 weeks).
measure: Acceptability: Intervention Satisfaction at Post-Intervention (6 weeks)
timeFrame: Participants' satisfaction with the intervention will be assessed at the end of the intervention (6 weeks).
measure: Feasibility: Retention Rates at 1-Month Follow-up (10 weeks)
timeFrame: Retention rates will be calculated at 1-month follow-up (10 weeks).
Secondary outcomes:
measure: Change from Baseline in Avoidant Coping at Post-Intervention (6 weeks)
timeFrame: Avoidant coping will be measured at baseline and post-intervention (6-weeks) for all three groups (patients, family caregivers, and health care providers).
measure: Change from Baseline in Avoidant Coping at 1-Month Follow-up (10 weeks)
timeFrame: 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).
measure: Change from Baseline in Quality of Life at Post-Intervention (6 weeks)
timeFrame: Quality of life will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
measure: Change from Baseline in Quality of Life at 1-Month Follow-up (10 weeks)
timeFrame: 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).
measure: Change from Baseline in Depression at Post-Intervention (6 weeks)
timeFrame: Depression will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
measure: Change from Baseline in Depression at 1-Month Follow-up (10 weeks)
timeFrame: 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).
measure: Change from Baseline in Anxiety at Post-Intervention (6 weeks)
timeFrame: Anxiety will be measured at baseline and post-intervention (6 weeks) for all three groups (patients, family caregivers, and health care providers).
measure: Change from Baseline in Anxiety at 1-Month Follow-up (10 weeks)
timeFrame: 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).
measure: Change from Baseline in Readiness for Advance Care Planning at Post-Intervention (6 weeks)
timeFrame: Readiness for advance care planning will be measured at baseline and post-intervention (6 weeks) for patients only.
measure: Change from Baseline in Readiness for Advance Care Planning at 1-Month Follow-up (10 weeks)
timeFrame: Readiness for advance care planning will be measured at baseline and at 1-month follow-up (10 weeks) for patients only.
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University School of Medicine
name: Shelley A. Johns, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
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.