NCT07835841

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Dec 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

September 17, 2026

Last Update Submit

September 17, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From baseline up to 180 days post-transplant

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Supportive care (spiritual blessing of stem cells)

EXPERIMENTAL

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.

Other: Electronic Health Record ReviewProcedure: Spiritual TherapyOther: Survey Administration

Interventions

Complete pre-transplant discussion

Supportive care (spiritual blessing of stem cells)

Ancillary studies

Supportive care (spiritual blessing of stem cells)

Ancillary studies

Supportive care (spiritual blessing of stem cells)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥ 18 years) undergoing autologous or allogeneic SCT
  • English proficiency (verbal and written)
  • Willing to engage in spiritual care discussions

You may not qualify if:

  • Patients opting to have blessings performed privately (non-study chaplain)
  • Cognitive impairment or psychiatric instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Interventions

Spiritual Therapies

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Srinivas S Devarakonda

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 23, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 23, 2026

Record last verified: 2026-09

Locations