Hematopoietic and Lymphatic System NeoplasmNCT07835841
Blessing Stem Cells to Improve Spiritual Well Being and Quality of Life for Patients Undergoing Hematopoietic Stem Cell Transplantation
A study testing Electronic Health Record Review, Spiritual Therapy and Survey Administration in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Electronic Health Record Review, Spiritual Therapy and Survey Administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥ 18 years) undergoing autologous or allogeneic SCT
- English proficiency (verbal and written)
- Willing to engage in spiritual care discussions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Srinivas S. Devarakonda
About this study
Official title: Pilot Study on the Impact of Spiritual Blessing Stem Cells in Hematopoietic Stem Cell Transplantation
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- Being tested
- Electronic Health Record Review, Spiritual Therapy, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
Spiritual TherapyProcedure or surgery
Complete pre-transplant discussion
Spiritual TherapyProcedure or surgery
Receive spiritual blessing of stem cells
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electronic Health Record Review; Procedure: Spiritual Therapy; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline up to 180 days post-transplant
Secondary outcomes (8)
Time to neutrophil engraftment
Will be compared between the intervention and control group using independent t-tests or Mann-Whitney U tests.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the date of infusion to progression or death, assessed up to 365 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivas Devarakonda, Ohio State University Comprehensive Cancer Center
- Investigators
- Srinivas S Devarakonda, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835841
- Sponsor's protocol ID
- OSU-25212
- Other IDs
- NCI-2026-06504
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Impact of Spiritual Blessing Stem Cells in Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07835841
- Acronym / sponsor ID
- OSU-25212
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (spiritual blessing of stem cells) | Experimental | Other: Electronic Health Record Review, Procedure: Spiritual Therapy, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥ 18 years) undergoing autologous or allogeneic SCT
- English proficiency (verbal and written)
- Willing to engage in spiritual care discussions
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewAncillary studies | Other | Supportive care (spiritual blessing of stem cells) |
| Spiritual TherapyComplete pre-transplant discussion | Procedure or surgery | Supportive care (spiritual blessing of stem cells) |
| Spiritual TherapyReceive spiritual blessing of stem cells | Procedure or surgery | Supportive care (spiritual blessing of stem cells) |
| Survey AdministrationAncillary studies | Other | Supportive care (spiritual blessing of stem cells) |
Primary outcome
Quality of life
Time frame: 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
Time frame: 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.
8 secondary outcomes
Time to neutrophil engraftment
Time frame: From transplant to 180 days post-transplant
Time to platelet engraftment
Time frame: From transplant to 180 days post-transplant
Infusion reactions
Time frame: From baseline to 180 days post-transplant
Infection
Time frame: From baseline to 180 days post-transplant
Hospitalizations
Time frame: From baseline to 180 days post-transplant
Incidence of graft versus host disease (GVHD)
Time frame: From baseline to 180 days post-transplant
Overall survival
Time frame: From the date of infusion to death from any cause, assessed up to 365 days post-transplant
Progression free survival
Time frame: From the date of infusion to progression or death, assessed up to 365 days post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Srinivas S Devarakonda principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Health Record Review, Spiritual Therapy and Survey Administration in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: From baseline up to 180 days post-transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.