Lymphoma, Plasma Cell Myeloma
Conditions
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. 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.
Detailed description
PRIMARY OBJECTIVE: I. To examine the feasibility, adoption, extent of implementation, and fidelity of chaplain-delivered Compassion Centered Spiritual Health (CCSH). OUTLINE: Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health (CCSH) over 30 minutes with a chaplain while impatient.
Interventions
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURESpiritual Therapy
Deliver or undergo Compassion Centered Spiritual Health (CCSH) session
Sponsors
National Cancer Institute (NCI)
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity to Intervention Delivery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sessions Completed | 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. |
| Percentage of Cognitive Based Compassion Training | 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. |
| Responsiveness | Up to 3 months | Evaluate the rate of responsiveness in each session, operationalized as maximally, moderately, or minimally enthusiastic and attentive during each. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supportive Care (CCSH) 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 | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Supportive Care (CCSH) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 57 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Fidelity to Intervention Delivery | 19.9 score on a scale | Standard Deviation 4.84 |
Secondary
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.
Time frame: Up to 3 months
Population: Evaluated the number of participants categorized as low (\< 70%), medium (70 - 80%) and high (\> 80%) adherence.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Number of Sessions Completed | Low: participants who had low adherence range | 12 Participants |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Number of Sessions Completed | Medium: participants who had medium adherence | 10 Participants |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Number of Sessions Completed | High: participants who had high adherence | 8 Participants |
Secondary
Percentage of Cognitive Based Compassion Training
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.
Time frame: Up to 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Percentage of Cognitive Based Compassion Training | Number of participants enrolled who did not complete any sessions | 3 Participants |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Percentage of Cognitive Based Compassion Training | Number of Enrolled Participants that Completed a Single Session | 9 Participants |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Percentage of Cognitive Based Compassion Training | Number of Enrolled Participants that Completed Two Sessions | 10 Participants |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Percentage of Cognitive Based Compassion Training | Number of Enrolled Participants that Completed Three Sessions | 3 Participants |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Percentage of Cognitive Based Compassion Training | Number of Enrolled Participants that Completed Four Sessions | 4 Participants |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Percentage of Cognitive Based Compassion Training | Number of Enrolled Participants that Completed Five Sessions | 1 Participants |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Percentage of Cognitive Based Compassion Training | Number of Enrolled Enrolled Participants with High Dosage to CCSH | 8 Participants |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Percentage of Cognitive Based Compassion Training | Number of Enrolled Participants with Moderate Dosage to CCSH | 10 Participants |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Percentage of Cognitive Based Compassion Training | Number of Enrolled Participants with Low Dosage to CCSH | 12 Participants |
Secondary
Responsiveness
Evaluate the rate of responsiveness in each session, operationalized as maximally, moderately, or minimally enthusiastic and attentive during each.
Time frame: Up to 3 months
Population: The 30 participants' responsiveness was rated for 54 sessions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Responsiveness | Number of sessions rated as maximum responsiveness | 33 number of sessions |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Responsiveness | Number of sessions rated as moderate Responsiveness | 17 number of sessions |
| Supportive Care: Compassion Centered Spiritual Health (CCSH) | Responsiveness | Number of sessions rated as minimal Responsiveness | 4 number of sessions |