NCT05495737进行中（未招募）不适用
A Pragmatic Randomized Control Trial of Nurse-Delivered Brief Meaning Centered Psychotherapy for Homebound Palliative Care Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 81
- 试验地点
- 4
- 主要终点
- MPI Competency Ratings
研究概览
简要总结
The purpose of this study is to train nurses from the VNS Health Visiting Nurse Service to deliver Meaning-Centered Psychotherapy for Palliative Care Patients (MCP-PC) to homebound people, and to evaluate how effective MCP-PC is for people with cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant Inclusion Criteria:
- •Nurses (all phases):
- •Per self-report, providing direct care services at VNS Health
- •Per self-report, fluent in English**
- •Per self-report, is age 18 or older
- •Patients (all phases):
- •Per health record and/or self-report, is a patient in the VNS Health home health agency division (post-acute care)
- •Per health record and/or self-report, is age 18 or older
- •Per health record, has a cancer diagnosis and a rating of ≥ 2 on Symptom Control Scale
- •Per health record and/or self-report, fluent in English**
- •Has a score of ≥ 4 on Callahan cognitive screener
- •Has a score of ≥ 4 on Distress Thermometer (N/A for Training Case Participants)
- •Language verification: For both nurses and patients, prior to enrollment, all will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify
- •English fluency necessary for participation in the study:
- •How well do you speak English? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
- •What is your preferred language for healthcare? (must respond English)
- •Participant
排除标准
- •Nurses (all phases):
- •Per self-report, planning to leave position at VNS Health in the next 6 months
- •Patients (all phases):
- •Per health record and/or self-report, has a diagnosis of Alzheimer's, dementia, or other organic brain disorder and in the judgment of the PIs is unable to meaningfully participate.
- •Per health record, has impaired decision-making capacity
- •Per health record and/or self-report, is permanently placed in a nursing home
- •Per health record and/or self-report, is currently receiving Hospice care
研究组 & 干预措施
Phase 2: Patient Participants Meaning-Centered Psychotherapy/MCP-PC Intervention Arm
n=35
干预措施: Meaning-Centered Psychotherapy/MCP-PC (Behavioral)
Phase 2: Patient Participants Treatment As Usual/TAU Intervention Arm
n=35
干预措施: Treatment As Usual/TAU (Behavioral)
Phase 2: Nurse Participants
n=8-10 nurses
干预措施: Meaning-Centered Psychotherapy/MCP-PC Training (Behavioral)
Phase 1: Nurse Participants
n=8-10 nurses
干预措施: Meaning-Centered Psychotherapy/MCP-PC Training (Behavioral)
Phase 1: Patient Participants
n=8-10 patients
干预措施: Meaning-Centered Psychotherapy/MCP-PC (Behavioral)
结局指标
主要结局
MPI Competency Ratings
时间窗: 2 years
Phase I portion: To refine the MCP-PC training and study procedures for homecare delivery by nurse interventionists as determined by providers' MPI Competency Ratings
次要结局
未报告次要终点
研究者
研究点 (4)
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