Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERElectronic Health Record Review
Ancillary studies
PROCEDURESpiritual Therapy
Complete pre-transplant discussion
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥ 18 years) undergoing autologous or allogeneic SCT * English proficiency (verbal and written) * Willing to engage in spiritual care discussions
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to neutrophil engraftment | From transplant to 180 days post-transplant | Will be compared between the intervention and control group using independent t-tests or Mann-Whitney U tests. |
| Time to platelet engraftment | From transplant to 180 days post-transplant | Will be compared between the intervention and control group using independent t-tests or Mann-Whitney U tests. |
| Infusion reactions | From baseline to 180 days post-transplant | Will summarize using frequency and proportions, and compare between the intervention and control group using chi-square or Fisher's exact tests. |
| Infection | From baseline to 180 days post-transplant | Will summarize using frequency and proportions, and compare between the intervention and control group using chi-square or Fisher's exact tests. |
| Hospitalizations | From baseline to 180 days post-transplant | Will summarize using frequency and proportions, and compare between the intervention and control group using chi-square or Fisher's exact tests. |
| Incidence of graft versus host disease (GVHD) | From baseline to 180 days post-transplant | 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. |
| Overall survival | From the date of infusion to death from any cause, assessed up to 365 days post-transplant | Will be estimated using Kaplan-Meier methods, compared with log-rank tests, and modeled using Cox proportional hazards models. |
| Progression free survival | From the date of infusion to progression or death, assessed up to 365 days post-transplant | Will be estimated using Kaplan-Meier methods, compared with log-rank tests, and modeled using Cox proportional hazards models. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORSrinivas S Devarakonda
Ohio State University Comprehensive Cancer Center
Outcome results
None listed