Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care): Feasibility of a Synergistic Intervention for Patients, Family Caregivers, and Providers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Feasibility: Recruitment Rates at Baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •Oncologists:
- •Planning to leave current practice setting for other employment in the next 3 months.
- •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.
结局指标
主要结局
Feasibility: Recruitment Rates at Baseline
时间窗: Recruitment rates will be estimated at baseline.
The number of individuals who are eligible will be divided by the number of individuals approached.
Feasibility: Enrollment Rates at Baseline
时间窗: Enrollment rates will be caluclated at baseline.
The number of enrolled individuals will be divided by the number of eligible individuals.
Feasibility: Attendance at Post-Intervention (6 weeks)
时间窗: 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).
Feasibility: Retention Rates at Post-Intervention (6 weeks)
时间窗: 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.
Acceptability: Intervention Satisfaction at Post-Intervention (6 weeks)
时间窗: 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).
Feasibility: Retention Rates at 1-Month Follow-up (10 weeks)
时间窗: 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.
次要结局
- 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 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 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 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).)
- Change from Baseline in Depression at 1-Month Follow-up (10 weeks)(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).)
- Change from Baseline in Anxiety at Post-Intervention (6 weeks)(Anxiety 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 Anxiety at 1-Month Follow-up (10 weeks)(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).)
- Change from Baseline in Readiness for Advance Care Planning at Post-Intervention (6 weeks)(Readiness for advance care planning will be measured at baseline and post-intervention (6 weeks) for patients only.)
- Change from Baseline in Readiness for Advance Care Planning at 1-Month Follow-up (10 weeks)(Readiness for advance care planning will be measured at baseline and at 1-month follow-up (10 weeks) for patients only.)