Chaplain-Delivered Compassion Meditation to Improve Spiritual Care of Patients Receiving Stem Cell Transplantation

Multiple Myeloma Clinical Trial

Official title:

Randomized Pilot Study of Chaplain-Delivered Compassion Meditation for Patients Receiving Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06328699
• Other study ID #: STUDY00006456
• Secondary ID: EU6011-23K01AT01
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: March 2024
• Source: Emory University
• Contact: Jennifer Mascaro, PhD
• Phone: 404-727-4301
• Email: jmascar[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial tests the feasibility, implementation and acceptability of chaplain delivered compassion meditation in order to improve spiritual care for patients receiving stem cell transplantation. Hospital chaplains play a vital role in delivering emotional and spiritual care to a broad range of both religious and non-religious patients for a wide variety of stressors, and extensive research indicates that spiritual consults impact patient outcomes and satisfaction. Compassion meditation is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling debilitating ruminative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others. Engaging in chaplain delivered compassion meditation may improve the spiritual care for patients receiving stem cell transplantation.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 15, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma

Intervention

Procedure:
• Spiritual Therapy
Undergo chaplain led compassionate centered spiritual health sessions

Other:
• Best Practice
Receive a traditional chaplain consultation and will receive care upon request

Locations

Country	Name	City	State
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - patient enrollment and treatment-specific retention rates	Will measure and characterize the proportion of eligible patient screens who enroll and treatment-specific retention rates.	Up to 8 months
Secondary	Patient Characteristics Affecting Acceptability - Chaplain Satisfaction Survey	We will examine whether scores on the chaplain satisfaction survey vary based on patient sociodemographic variables (biological sex, race)	Up to 8 months
Secondary	Functional Assessment of Cancer Therapy-Bone Marrow Transplant [FACT-BMT]	Impact of chaplain-delivered compassion-centered spiritual health on quality of life	Up to 8 months
Secondary	Acceptability - Chaplain Satisfaction Survey	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