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
- 288
- 试验地点
- 3
- 主要终点
- Patients' spiritual wellness as assessed by measures of spiritual well-being
研究概览
简要总结
This study aims to determine the effects of 2 spiritual care interventions. Spiritual wellness and healthcare service utilization will be measured from a sample of advanced cancer patients recruited from outpatient settings.
详细描述
This study is a stratified permuted-block RCT to determine the effects of 2 spiritual care interventions on advanced cancer patients' spiritual wellness (i.e., spiritual well-being and satisfaction of spiritual care needs) and specific forms of healthcare service utilization (i.e., hospice enrollment and ICU admissions) in a sample of advanced cancer patients (N=288) recruited from outpatient settings. Patients will be assigned to "Spiritual Care Intervention #1" (active 1), "Spiritual Care Intervention #2" (active 2), or "Spiritual Care Intervention #3" (control) arm of the trial (overall ratio 1:1:1) using permuted-block randomization within strata defined by geographic location (NYC, Houston Metro Area) and recruitment site (NYC: BMH; Houston Metro Area: UTMB, MDACC). Spiritual care intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Only 1 of the 2 active interventions will be administered at each site at a given time to avoid within-site cross-contamination between the 2 active intervention arms of the trial.
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
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 an advanced cancer.
- •Member of a religious faith community organization.
- •Fluent in English.
排除标准
- •Received spiritual care from a healthcare chaplain within the past 2 months.
- •Too weak or cognitively impaired to engage in study activities.
研究组 & 干预措施
Spiritual Care Intervention #1
This is an 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 also an 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 #2 (Behavioral)
Spiritual Care Intervention #3
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 #3 (Behavioral)
结局指标
主要结局
Patients' spiritual wellness as assessed by measures of spiritual well-being
时间窗: 2 months
The spiritual well-being outcome measure for this trial is the total score for the 12-item Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale \[FACIT-Sp-12\], which has a range from 0 to 48. The higher the score, the greater the spiritual well-being.
Participants' number of hospice enrollments
时间窗: up to 12 months
Number of hospice enrollments over time, up to 12 months.
Participants' number of ICU admissions
时间窗: up to 12 months
Number of ICU admissions over time, up to 12 months.
Patients' spiritual wellness as assessed by measures of satisfaction of spiritual care needs.
时间窗: 2 months
The satisfaction of spiritual care needs outcome measure for this trial is a reverse-coded total score for the 13-item Spiritual Needs Assessment for Patients \[SNAP\], which measures unmet spiritual care needs and has a range from 13 to 52. The higher the reverse-coded score, the greater the satisfaction of spiritual care needs.
次要结局
- Patients' quality of life(2 months)