Trial Outcomes & Findings for Chaplain-Delivered Compassion Meditation to Improve Quality of Life in Patients Receiving a Stem Cell Transplant (NCT NCT05274763)

Last Updated: 2024-04-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

3 months

Results posted on

2024-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Supportive Care: Compassion Centered Spiritual Health (CCSH) Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health (CCSH) over 30 minutes with a chaplain while impatient. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Spiritual Therapy: Deliver or undergo Compassion Centered Spiritual Health ssession
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Supportive Care: Compassion Centered Spiritual Health (CCSH) Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health (CCSH) over 30 minutes with a chaplain while impatient. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Spiritual Therapy: Deliver or undergo Compassion Centered Spiritual Health ssession
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supportive Care (CCSH) n=30 Participants Patients undergo 4 to 8 sessions (2-4 per week) of CCSH over 30 minutes with a chaplain while impatient. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Spiritual Therapy: Deliver or undergo CCSH session
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Supportive Care: Compassion Centered Spiritual Health (CCSH) n=30 Participants Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health over 30 minutes with a chaplain while impatient. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Spiritual Therapy: Deliver or undergo Compassion Centered Spiritual Health session
Fidelity to Intervention Delivery	19.9 score on a scale Standard Deviation 4.84

SECONDARY outcome

Timeframe: Up to 3 months

Population: Evaluated the number of participants categorized as low (\< 70%), medium (70 - 80%) and high (\> 80%) adherence.

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

Outcome measures

Outcome measures
Measure	Supportive Care: Compassion Centered Spiritual Health (CCSH) n=30 Participants Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health over 30 minutes with a chaplain while impatient. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Spiritual Therapy: Deliver or undergo Compassion Centered Spiritual Health session
Number of Sessions Completed Low: participants who had low adherence range	12 Participants
Number of Sessions Completed Medium: participants who had medium adherence	10 Participants
Number of Sessions Completed High: participants who had high adherence	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Supportive Care: Compassion Centered Spiritual Health (CCSH) n=30 Participants Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health over 30 minutes with a chaplain while impatient. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Spiritual Therapy: Deliver or undergo Compassion Centered Spiritual Health session
Percentage of Cognitive Based Compassion Training Number of participants enrolled who did not complete any sessions	3 Participants
Percentage of Cognitive Based Compassion Training Number of Enrolled Participants that Completed a Single Session	9 Participants
Percentage of Cognitive Based Compassion Training Number of Enrolled Participants that Completed Two Sessions	10 Participants
Percentage of Cognitive Based Compassion Training Number of Enrolled Participants that Completed Three Sessions	3 Participants
Percentage of Cognitive Based Compassion Training Number of Enrolled Participants that Completed Four Sessions	4 Participants
Percentage of Cognitive Based Compassion Training Number of Enrolled Participants that Completed Five Sessions	1 Participants
Percentage of Cognitive Based Compassion Training Number of Enrolled Enrolled Participants with High Dosage to CCSH	8 Participants
Percentage of Cognitive Based Compassion Training Number of Enrolled Participants with Moderate Dosage to CCSH	10 Participants
Percentage of Cognitive Based Compassion Training Number of Enrolled Participants with Low Dosage to CCSH	12 Participants

SECONDARY outcome

Timeframe: Up to 3 months

Population: The 30 participants' responsiveness was rated for 54 sessions

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

Outcome measures

Outcome measures
Measure	Supportive Care: Compassion Centered Spiritual Health (CCSH) n=30 Participants Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health over 30 minutes with a chaplain while impatient. Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Spiritual Therapy: Deliver or undergo Compassion Centered Spiritual Health session
Responsiveness Number of sessions rated as maximum responsiveness	33 number of sessions
Responsiveness Number of sessions rated as moderate Responsiveness	17 number of sessions
Responsiveness Number of sessions rated as minimal Responsiveness	4 number of sessions

Adverse Events

Supportive Care (CCSH)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Mascaro

Emory University

Phone: 404-727-4301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place