Pilot Study on the Impact of Spiritual Blessing Stem Cells in Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
This clinical trial evaluates the impact of blessing stem cell products before infusion on spiritual well-being and quality of life for patients undergoing hematopoietic stem cell transplantation. Stem cell transplantation represents a transformative medical and personal journey for patients and families. For stem cell transplantation (SCT) recipients, higher levels of spiritual well-being correlate with reduced anxiety and depression, greater hope, and improved emotional stability. Because quality of life often declines after SCT, spiritual support becomes crucial. This trial uses a culturally adaptable, standardized blessing that is personalized to align with each patient's faith tradition or personal belief system that may improve spiritual well-being and quality of life for patients undergoing hematopoietic stem cell transplantation.
详细描述
PRIMARY OBJECTIVES:
I. Patient quality of life (QOL) and perceptions of spiritual support measured using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT), Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP-12), and Brief Multidimensional Measure of Religiousness/Spirituality (BMMRS).
II. Changes in QOL and spiritual support measured at baseline (start of conditioning to day [D]-1), D0, D+15 (+/- 2 days), D+30 (+/- 3 days), D+90 (+/- 5 days), and D+180 (+/- 10 days) post-transplant.
SECONDARY OBJECTIVES:
I. Time to neutrophil and platelet engraftment. II. Rates of transplant complications, including infusion reaction, infections, and graft versus host disease (GVHD) from baseline (start of conditioning) to 180 days post-transplant.
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
- •Adults (≥ 18 years) undergoing autologous or allogeneic SCT
- •English proficiency (verbal and written)
- •Willing to engage in spiritual care discussions
排除标准
- •Patients opting to have blessings performed privately (non-study chaplain)
- •Cognitive impairment or psychiatric instability
- •Pregnant individuals - this exclusion is not related to the blessing intervention but reflects the fact that pregnant individuals are not eligible for SCT under standard oncology transplant protocols due to the high-dose chemotherapy and potential teratogenic effects
研究组 & 干预措施
Supportive care (spiritual blessing of stem cells)
Patients complete a pre-transplant discussion with the chaplaincy staff to discuss spiritual preferences. Patients choose whether to receive a chaplain-led blessing of their stem cells before infusion. The blessing intervention will consist of a standardized core script delivered immediately prior to stem cell infusion with optional additions that are tailored to the patient's stated spiritual or religious tradition. The spiritual leader performing the blessing will be matched, when possible, to the patient's spiritual tradition. For patients who do not identify with a faith tradition, the chaplain will offer a meaning-centered blessing focused on hope, healing, and gratitude for the transplant process.
干预措施: Electronic Health Record Review (Other)
Supportive care (spiritual blessing of stem cells)
Patients complete a pre-transplant discussion with the chaplaincy staff to discuss spiritual preferences. Patients choose whether to receive a chaplain-led blessing of their stem cells before infusion. The blessing intervention will consist of a standardized core script delivered immediately prior to stem cell infusion with optional additions that are tailored to the patient's stated spiritual or religious tradition. The spiritual leader performing the blessing will be matched, when possible, to the patient's spiritual tradition. For patients who do not identify with a faith tradition, the chaplain will offer a meaning-centered blessing focused on hope, healing, and gratitude for the transplant process.
干预措施: Spiritual Therapy (Procedure)
Supportive care (spiritual blessing of stem cells)
Patients complete a pre-transplant discussion with the chaplaincy staff to discuss spiritual preferences. Patients choose whether to receive a chaplain-led blessing of their stem cells before infusion. The blessing intervention will consist of a standardized core script delivered immediately prior to stem cell infusion with optional additions that are tailored to the patient's stated spiritual or religious tradition. The spiritual leader performing the blessing will be matched, when possible, to the patient's spiritual tradition. For patients who do not identify with a faith tradition, the chaplain will offer a meaning-centered blessing focused on hope, healing, and gratitude for the transplant process.
干预措施: Survey Administration (Other)
结局指标
主要结局
Quality of life
时间窗: From baseline up to 180 days post-transplant
Assessed using Functional Assessment of Cancer Therapy-Bone Marrow Transplant. Will be compared between intervention and control groups over time using repeated-measures analysis of variance (ANOVA) or linear mixed effects models, with group × time interaction terms.
Spiritual support
时间窗: From baseline up to 180 days post-transplant
Assessed via Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being and Brief Multidimensional Measure of Religiousness/Spirituality. Compared between intervention and control groups over time using repeated-measures ANOVA or linear mixed effects models, with group × time interaction terms.
次要结局
- Time to neutrophil engraftment(From transplant to 180 days post-transplant)
- Time to platelet engraftment(From transplant to 180 days post-transplant)
- Infusion reactions(From baseline to 180 days post-transplant)
- Infection(From baseline to 180 days post-transplant)
- Hospitalizations(From baseline to 180 days post-transplant)
- Incidence of graft versus host disease (GVHD)(From baseline to 180 days post-transplant)
- Overall survival(From the date of infusion to death from any cause, assessed up to 365 days post-transplant)
- Progression free survival(From the date of infusion to progression or death, assessed up to 365 days post-transplant)
研究者
Srinivas Devarakonda
Principal Investigator
Ohio State University Comprehensive Cancer Center