Pilot Trial of Spiritual Care Interventions for Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Measure of Spiritual Well-Being as assessed by Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale [FACIT-Sp].
研究概览
简要总结
This is a pilot trial of the effects of spiritual care interventions on spiritual well-being and readiness to engage in advance care planning (ACP) among black patients with advanced cancer recruited from outpatient settings to determine the feasibility of conducting a larger trial of effects of early integration of spiritual care into outpatient oncology care on patient outcomes.
详细描述
This will be a pilot, stratified block randomized controlled trial of the effects of healthcare chaplain services on spiritual well-being and advance care planning (ACP) among black advanced cancer patients (N=64) in outpatient settings at two medical institutions: NYP/Brooklyn Methodist Hospital (BMH) and the University of Texas Medical Branch (UTMB). The investigators will randomly assign patients in a 1:1 ratio to either the Spiritual Care Intervention #1 or Spiritual Care Intervention #2 arm of the trial. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Trial outcomes will be assessed at the primary endpoint, 2 months after the onset of the spiritual care intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Triple (Participant, Care Provider, Outcomes Assessor). The participant's oncologist is the care provider who is masked. This masking is needed to ensure the scientific integrity of the trial.
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
- •Diagnosed with a life-limiting, advanced cancer.
- •Identifies racially as black or African American.
- •Is fluent in English.
排除标准
- •Have received medical system-based spiritual care within the past 2 months.
- •Have already completed a DNR order.
- •Are too weak or cognitively impaired to engage in study activities
研究组 & 干预措施
Spiritual Care Intervention #1
This is the experimental condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study.
干预措施: Spiritual Care Intervention #1 (Behavioral)
Spiritual Care Intervention #2
This is the active comparator condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study.
干预措施: Spiritual Care Intervention #2 (Other)
结局指标
主要结局
Measure of Spiritual Well-Being as assessed by Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale [FACIT-Sp].
时间窗: 2 months
The spiritual well-being outcome measure for this trial is the total score for the Spiritual Well-Being Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12-item Scale \[FACIT-Sp-12\], which has a range from 0 to 48. Higher scores mean greater spiritual well-being.
Readiness to Engage in Advance Care Planning as assessed by the Advance Care Planning Engagement Survey.
时间窗: 2 months
The readiness to engage in advance care planning outcome measure for this trial is the average score of 4 items in the 4-item version of the Advance Care Planning Engagement Survey. Each item as well as the average score of the 4 items have a range of 1 to 5. Higher scores mean greater readiness to engage in ACP.
次要结局
- Number of individual participants who complete a DNR order.(2 months)