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| ID | Type | Description | Link |
|---|---|---|---|
| R21MD017652 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| New York Presbyterian Brooklyn Methodist Hospital | OTHER |
| The University of Texas Medical Branch, Galveston | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This is a pilot trial of the effects of spiritual care interventions on spiritual well-being and readiness to engage in advance care planning (ACP) among black patients with advanced cancer recruited from outpatient settings to determine the feasibility of conducting a larger trial of effects of early integration of spiritual care into outpatient oncology care on patient outcomes.
This will be a pilot, stratified block randomized controlled trial of the effects of healthcare chaplain services on spiritual well-being and advance care planning (ACP) among black advanced cancer patients (N=64) in outpatient settings at two medical institutions: NYP/Brooklyn Methodist Hospital (BMH) and the University of Texas Medical Branch (UTMB). The investigators will randomly assign patients in a 1:1 ratio to either the Spiritual Care Intervention #1 or Spiritual Care Intervention #2 arm of the trial. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Trial outcomes will be assessed at the primary endpoint, 2 months after the onset of the spiritual care intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiritual Care Intervention #1 | Experimental | This is the experimental condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. |
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| Spiritual Care Intervention #2 | Active Comparator | This is the active comparator condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiritual Care Intervention #1 | Behavioral | Experimental |
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| Measure | Description | Time Frame |
|---|---|---|
| Measure of Spiritual Well-Being as assessed by Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale [FACIT-Sp]. | The spiritual well-being outcome measure for this trial is the total score for the Spiritual Well-Being Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12-item Scale [FACIT-Sp-12], which has a range from 0 to 48. Higher scores mean greater spiritual well-being. | 2 months |
| Readiness to Engage in Advance Care Planning as assessed by the Advance Care Planning Engagement Survey. | The readiness to engage in advance care planning outcome measure for this trial is the average score of 4 items in the 4-item version of the Advance Care Planning Engagement Survey. Each item as well as the average score of the 4 items have a range of 1 to 5. Higher scores mean greater readiness to engage in ACP. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of individual participants who complete a DNR order. | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madison K Pavao, B.S. | Contact | (646)962-5650 | mkp4005@med.cornell.edu | |
| Paul K Maciejewski, Ph.D. | Contact | (212) 746-2229 | pam2056@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul K Maciejewski, Ph.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Brooklyn Methodist Hospital | Recruiting | Brooklyn | New York | 11215 | United States |
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Triple (Participant, Care Provider, Outcomes Assessor). The participant's oncologist is the care provider who is masked. This masking is needed to ensure the scientific integrity of the trial.
| Spiritual Care Intervention #2 |
| Other |
Active Comparator |
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| The University of Texas Medical Branch, Galveston | Recruiting | Galveston | Texas | 77555 | United States |
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