Chaplain-Delivered Compassion Meditation to Improve Quality of Life in Patients Receiving a Stem Cell Transplant
Primary Purpose
Lymphoma, Plasma Cell Myeloma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality-of-Life Assessment
Questionnaire Administration
Spiritual Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Lymphoma
Eligibility Criteria
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:
- CHAPLAIN: There will be no exclusion criteria and no consequence to the chaplains for refusing to volunteer
- PATIENT: Neurologic or cognitive problems that preclude chaplain-delivered CCSH
Sites / Locations
- Emory University Hospital/Winship Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive Care (CCSH)
Arm Description
Patients undergo 4 to 8 sessions (2-4 per week) of CCSH over 30 minutes with a chaplain while impatient.
Outcomes
Primary Outcome Measures
Fidelity to intervention delivery
Chaplains will deliver between four and eight 30-minute sessions (2-4 times per week) to evaluate the fidelity of implementation (FOI).
Administer the (4 min) Scottish Patient Reported Outcome Measure. The Patient Reported Outcome Measure is an 18-item Likert-scale that assesses how a hospitalized patient felt about the pastoral care visit both during the consult and after it.
The scale will indicate the following range: 5-25, with higher scores indicating more improvement as a result of the chaplain visit and lower scores indicating less improvement as a result of the chaplain visit.
Secondary Outcome Measures
Number of sessions completed
Adherence will be evaluated as the percent of sessions completed by patients and characterized as "low" (< 70%), "moderate" (70-80%),"high" (> 80%) adherence.
Dosage
Quantify the percentage of cognitive based compassion training (cbct) that patients receive. Characterize the modal number of sessions received as well as the range of sessions completed by all patients. From the range, we will create categories of "low" (<70%), "moderate" (70-80%),"high" (> 80%) dosage.
Responsiveness
Evaluate the rate of which patients were engaged in each session, operationalized as "maximally," "moderately", or "minimally" enthusiastic and attentive during each. We will quantify the average patient engagement for all sessions, as well as the average responsiveness for each session.
Full Information
NCT ID
NCT05274763
First Posted
February 25, 2022
Last Updated
May 18, 2023
Sponsor
Emory University
Collaborators
National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05274763
Brief Title
Chaplain-Delivered Compassion Meditation to Improve Quality of Life in Patients Receiving a Stem Cell Transplant
Official Title
A Feasibility Study of Chaplain-Delivered Compassion Meditation for Patients Receiving Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial tests whether chaplain-delivered compassion centered spiritual health (CCSH) works to improve quality of life in patients receiving a stem cell transplant. CCSH 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 negative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others, CCSH may help improve response to stress and reduce inflammation.
Detailed Description
PRIMARY OBJECTIVE:
I. To examine the feasibility, adoption, extent of implementation, and fidelity of chaplain-delivered CCSH.
OUTLINE:
Patients undergo 4 to 8 sessions (2-4 per week) of CCSH over 30 minutes with a chaplain while impatient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Plasma Cell Myeloma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive Care (CCSH)
Arm Type
Experimental
Arm Description
Patients undergo 4 to 8 sessions (2-4 per week) of CCSH over 30 minutes with a chaplain while impatient.
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Spiritual Therapy
Intervention Description
Deliver or undergo CCSH session
Primary Outcome Measure Information:
Title
Fidelity to intervention delivery
Description
Chaplains will deliver between four and eight 30-minute sessions (2-4 times per week) to evaluate the fidelity of implementation (FOI).
Administer the (4 min) Scottish Patient Reported Outcome Measure. The Patient Reported Outcome Measure is an 18-item Likert-scale that assesses how a hospitalized patient felt about the pastoral care visit both during the consult and after it.
The scale will indicate the following range: 5-25, with higher scores indicating more improvement as a result of the chaplain visit and lower scores indicating less improvement as a result of the chaplain visit.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Number of sessions completed
Description
Adherence will be evaluated as the percent of sessions completed by patients and characterized as "low" (< 70%), "moderate" (70-80%),"high" (> 80%) adherence.
Time Frame
Up to 1 year
Title
Dosage
Description
Quantify the percentage of cognitive based compassion training (cbct) that patients receive. Characterize the modal number of sessions received as well as the range of sessions completed by all patients. From the range, we will create categories of "low" (<70%), "moderate" (70-80%),"high" (> 80%) dosage.
Time Frame
Up to 1 year
Title
Responsiveness
Description
Evaluate the rate of which patients were engaged in each session, operationalized as "maximally," "moderately", or "minimally" enthusiastic and attentive during each. We will quantify the average patient engagement for all sessions, as well as the average responsiveness for each session.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
CHAPLAIN: There will be no exclusion criteria and no consequence to the chaplains for refusing to volunteer
PATIENT: Neurologic or cognitive problems that preclude chaplain-delivered CCSH
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Mascaro, PhD
Organizational Affiliation
Emory University Hospital/Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chaplain-Delivered Compassion Meditation to Improve Quality of Life in Patients Receiving a Stem Cell Transplant
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