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.
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. III. Overall survival (OS) and progression free survival (PFS) baseline from (start of conditioning) to 365 days post-transplant. EXPLORATORY OBJECTIVES: I. Between-group differences in cytokine and inflammatory markers: C-reactive protein (CRP), ferritin, interleukin (IL)-2, IL-2 receptor, IL-12, interferon (IF)-gamma, IL-4, IL-5, IL-13, IL-17, IL-8, IL-6, tumor necrosis factor (TNF)-alpha, IL-1β, IL-10 (cytokine panel 13) from baseline (start of conditioning to D-1), D0, D+15 (+/- 3 days), and D+30 (+/- 5 days) post-transplant will be performed in 15 patients who undergo allogeneic transplant only. II. Assessment of whether the blessing's effect differs by demographic subgroup (sex, race/ethnicity, and baseline spiritual affiliation), addressing potential disparities in spiritual care outcomes. OUTLINE: 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. After completion of study intervention, patients are followed up at day +15, +30, +90, and +180.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
Ancillary studies
Complete pre-transplant discussion
Receive spiritual blessing of stem cells
Ancillary studies
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Quality of life
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.
Time frame: From baseline up to 180 days post-transplant
Spiritual support
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.
Time frame: From baseline up to 180 days post-transplant
Time to neutrophil engraftment
Will be compared between the intervention and control group using independent t-tests or Mann-Whitney U tests.
Time frame: From transplant to 180 days post-transplant
Time to platelet engraftment
Will be compared between the intervention and control group using independent t-tests or Mann-Whitney U tests.
Time frame: From transplant to 180 days post-transplant
Infusion reactions
Will summarize using frequency and proportions, and compare between the intervention and control group using chi-square or Fisher's exact tests.
Time frame: From baseline to 180 days post-transplant
Infection
Will summarize using frequency and proportions, and compare between the intervention and control group using chi-square or Fisher's exact tests.
Time frame: From baseline to 180 days post-transplant
Hospitalizations
Will summarize using frequency and proportions, and compare between the intervention and control group using chi-square or Fisher's exact tests.
Time frame: From baseline to 180 days post-transplant
Incidence of graft versus host disease (GVHD)
Time from stem cell transplantation to the onset of GVHD will be calculated, treating relapse or death without GVHD as competing risks. Cumulative incidence rates will be estimated, and the associations between intervention and patients' characteristics on the risk of GVHD will be analyzed using Fine-Gray competing risk models.
Time frame: From baseline to 180 days post-transplant
Overall survival
Will be estimated using Kaplan-Meier methods, compared with log-rank tests, and modeled using Cox proportional hazards models.
Time frame: From the date of infusion to death from any cause, assessed up to 365 days post-transplant
Progression free survival
Will be estimated using Kaplan-Meier methods, compared with log-rank tests, and modeled using Cox proportional hazards models.
Time frame: From the date of infusion to progression or death, assessed up to 365 days post-transplant
The Ohio State University Comprehensive Cancer Center
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