- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06328699
Chaplain-Delivered Compassion Meditation to Improve Spiritual Care of Patients Receiving Stem Cell Transplantation
Randomized Pilot Study of Chaplain-Delivered Compassion Meditation for Patients Receiving Stem Cell Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To examine the feasibility, adoption, extent of implementation, acceptability and fidelity of chaplain-delivered compassion-centered spiritual health (CCSH).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive chaplain-led compassionate centered spiritual health sessions over 30 minutes, twice per week for up to 2 weeks.
ARM II: Patients receive a traditional chaplain consultation and care upon request, per standard of care.
After completion of study treatment, patients are followed up at 80-100 days and 6 months post treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University Hospital/Winship Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- PATIENT: Within 6 weeks of scheduled hematopoietic stem cell transplant (HSCT)
- PATIENT: > 18 years of age
- PATIENT: Speak and read English
- CHAPLAIN: Emory Healthcare chaplain
Exclusion Criteria:
- PATIENT: Patients will be excluded if they are cognitively impaired, on a ventilator, or are in a room requiring enteric precautions or airborne precautions (e.g., use of an N-95 mask requiring fit-testing) to enter
- CHAPLAIN: There will be no exclusion criteria and no consequence to the chaplains for refusing to volunteer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (Chaplain delivered compassion meditation)
Patients receive chaplain led compassionate centered spiritual health sessions over 30 minutes, twice per week for up to 2 weeks.
|
Undergo chaplain led compassionate centered spiritual health sessions
|
|
Active Comparator: Arm II (Traditional chaplain consultation)
Patients receive a traditional chaplain consultation and care upon request, per standard of care.
|
Receive a traditional chaplain consultation and will receive care upon request
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility - patient enrollment and treatment-specific retention rates
Time Frame: Up to 8 months
|
Will measure and characterize the proportion of eligible patient screens who enroll and treatment-specific retention rates.
|
Up to 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Characteristics Affecting Acceptability - Chaplain Satisfaction Survey
Time Frame: Up to 8 months
|
We will examine whether scores on the chaplain satisfaction survey vary based on patient sociodemographic variables (biological sex, race)
|
Up to 8 months
|
|
Functional Assessment of Cancer Therapy-Bone Marrow Transplant [FACT-BMT]
Time Frame: Up to 8 months
|
Impact of chaplain-delivered compassion-centered spiritual health on quality of life
|
Up to 8 months
|
|
Acceptability - Chaplain Satisfaction Survey
Time Frame: Up to 8 months
|
Will administer a post- chaplain-based compassion treatment (CBCT) intervention using chaplain satisfaction survey and will ask patients after each session if they would like to continue receiving CBCT sessions.
|
Up to 8 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Multiple Myeloma
Other Study ID Numbers
- STUDY00006456
- P30CA138292 (U.S. NIH Grant/Contract)
- K01AT010488 (U.S. NIH Grant/Contract)
- EU6011-23 (Other Identifier: Emory University Hospital/Winship Cancer Institute)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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