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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-00233 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00003563 | |||
| EU5492-21 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| K01AT010488 | U.S. NIH Grant/Contract | View source | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care | Experimental | Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health (CCSH) over 30 minutes with a chaplain while impatient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 months |
| Percentage of Cognitive Based Compassion Training |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Mascaro, PhD | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
Up to 3 months
No adverse event was reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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This study was not designed to evaluate efficacy, therefore no statistical analysis was developed or associated with this trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Mascaro | Emory University | 404-727-4301 | jmascar@emory.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 21, 2021 | Aug 29, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 11, 2022 | Aug 29, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D026443 | Spiritual Therapies |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Spiritual Therapy | Procedure | Deliver or undergo Compassion Centered Spiritual Health (CCSH) session |
|
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. |
| Up to 3 months |
| Responsiveness | Evaluate the rate of responsiveness in each session, operationalized as "maximally," "moderately", or "minimally" enthusiastic and attentive during each. | Up to 3 months |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| 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. | Evaluated the number of participants categorized as low (< 70%), medium (70 - 80%) and high (> 80%) adherence. | Posted | Count of Participants | Participants | Up to 3 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | Up to 3 months |
|
|
|
| Secondary | Responsiveness | Evaluate the rate of responsiveness in each session, operationalized as "maximally," "moderately", or "minimally" enthusiastic and attentive during each. | The 30 participants' responsiveness was rated for 54 sessions | Posted | Number | number of sessions | Up to 3 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| Title | Measurements |
|---|---|
|
|
| Number of Enrolled Participants that Completed Three Sessions |
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| Number of Enrolled Participants that Completed Four Sessions |
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| Number of Enrolled Participants that Completed Five Sessions |
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| Number of Enrolled Enrolled Participants with High Dosage to CCSH |
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| Number of Enrolled Participants with Moderate Dosage to CCSH |
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| Number of Enrolled Participants with Low Dosage to CCSH |
|
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