NCT05274763

Chaplain-Delivered Compassion Meditation to Improve Quality of Life in Patients Receiving a Stem Cell Transplant

Completed NA Results posted Last updated 16 April 2024

What this trial tests

NA trial testing Quality-of-Life Assessment in Lymphoma in 30 participants. Completed in 25 May 2022.

Timeline

21 March 2022

Primary endpoint
25 May 2022

25 May 2022

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	30
Start date	21 March 2022
Primary completion	25 May 2022
Estimated completion	25 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Quality-of-Life Assessment
• Questionnaire Administration
• Spiritual Therapy

Conditions studied

• Lymphoma — all drugs for Lymphoma →
• Plasma Cell Myeloma — all drugs for Plasma Cell Myeloma →

Sponsor

Emory University

Who can join

18 and older, any sex, with Lymphoma or Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fidelity to Intervention Delivery Primary · 3 months

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.

Group	Value	95% CI
Supportive Care: Compassion Centered Spiritual Health (CCSH)	19.9	± 4.84

Number of Sessions Completed Secondary · Up to 3 months

Adherence will be evaluated as the percent of sessions completed by patients and characterized as "low" (\< 70%), "moderate" (70-80%),"high" (\> 80%) adherence.

Low: participants who had low adherence range

Group	Value	95% CI
Supportive Care Compassion Centered Spiritual Health (CCSH)	12

Medium: participants who had medium adherence

Group	Value	95% CI
Supportive Care Compassion Centered Spiritual Health (CCSH)	10

High: participants who had high adherence

Group	Value	95% CI
Supportive Care Compassion Centered Spiritual Health (CCSH)	8

Percentage of Cognitive Based Compassion Training Secondary · Up to 3 months

Dosage is quantified as the amount (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, sessions will be categorized of "low" (\<70%), "moderate" (70-80%),"high" (\> 80%) dosage.

Number of participants enrolled who did not complete any sessions

Group	Value	95% CI
Supportive Care: Compassion Centered Spiritual Health (CCSH)	3

Number of Enrolled Participants that Completed a Single Session

Group	Value	95% CI
Supportive Care: Compassion Centered Spiritual Health (CCSH)	9

Number of Enrolled Participants that Completed Two Sessions

Group	Value	95% CI
Supportive Care: Compassion Centered Spiritual Health (CCSH)	10

Number of Enrolled Participants that Completed Three Sessions

Group	Value	95% CI
Supportive Care: Compassion Centered Spiritual Health (CCSH)	3

Number of Enrolled Participants that Completed Four Sessions

Group	Value	95% CI
Supportive Care: Compassion Centered Spiritual Health (CCSH)	4

Number of Enrolled Participants that Completed Five Sessions

Group	Value	95% CI
Supportive Care: Compassion Centered Spiritual Health (CCSH)	1

Number of Enrolled Enrolled Participants with High Dosage to CCSH

Group	Value	95% CI
Supportive Care: Compassion Centered Spiritual Health (CCSH)	8

Number of Enrolled Participants with Moderate Dosage to CCSH

Group	Value	95% CI
Supportive Care: Compassion Centered Spiritual Health (CCSH)	10

Responsiveness Secondary · Up to 3 months

Evaluate the rate of responsiveness in each session, operationalized as "maximally," "moderately", or "minimally" enthusiastic and attentive during each.

Number of sessions rated as maximum responsiveness

Group	Value	95% CI
Supportive Care Compassion Centered Spiritual Health (CCSH)	33

Number of sessions rated as moderate Responsiveness

Group	Value	95% CI
Supportive Care Compassion Centered Spiritual Health (CCSH)	17

Number of sessions rated as minimal Responsiveness

Group	Value	95% CI
Supportive Care Compassion Centered Spiritual Health (CCSH)	4

Sponsor's own description

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. Compassion Centered Spiritual Health (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, Compassion Centered Spiritual Health (CCSH) may help improve response to stress and reduce inflammation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.