Mindfully Optimizing Delivery of End-of-Life Care (NCT02367508) | Clinical Trial Compass
CompletedNot Applicable
Mindfully Optimizing Delivery of End-of-Life Care
31 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 capa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility: Recruitment Rates at Baseline
Timeframe: Recruitment rates will be estimated at baseline.
2
Feasibility: Enrollment Rates at Baseline
Timeframe: Enrollment rates will be caluclated at baseline.
3
Feasibility: Attendance at Post-Intervention (6 weeks)
Timeframe: Attendance will be calculated at the end of the intervention (6 weeks).
4
Feasibility: Retention Rates at Post-Intervention (6 weeks)
Timeframe: Retention rates will be calculated at the end of the intervention (6 weeks).
5
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).
6
Feasibility: Retention Rates at 1-Month Follow-up (10 weeks)
Timeframe: Retention rates will be calculated at 1-month follow-up (10 weeks).