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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR021159 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| New York Presbyterian Brooklyn Methodist Hospital | OTHER |
| The University of Texas Medical Branch, Galveston | OTHER |
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This study aims to determine the effects of 2 spiritual care interventions. Spiritual wellness and healthcare service utilization will be measured from a sample of advanced cancer patients recruited from outpatient settings.
This study is a stratified permuted-block RCT to determine the effects of 2 spiritual care interventions on advanced cancer patients' spiritual wellness (i.e., spiritual well-being and satisfaction of spiritual care needs) and specific forms of healthcare service utilization (i.e., hospice enrollment and ICU admissions) in a sample of advanced cancer patients (N=288) recruited from outpatient settings. Patients will be assigned to "Spiritual Care Intervention #1" (active 1), "Spiritual Care Intervention #2" (active 2), or "Spiritual Care Intervention #3" (control) arm of the trial (overall ratio 1:1:1) using permuted-block randomization within strata defined by geographic location (NYC, Houston Metro Area) and recruitment site (NYC: BMH; Houston Metro Area: UTMB, MDACC). Spiritual care intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Only 1 of the 2 active interventions will be administered at each site at a given time to avoid within-site cross-contamination between the 2 active intervention arms of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiritual Care Intervention #1 | Experimental | This is an 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 | Experimental | This is also an 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 #3 | 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 |
|---|---|---|
| Patients' spiritual wellness as assessed by measures of spiritual well-being | The spiritual well-being outcome measure for this trial is the total score for the 12-item Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale [FACIT-Sp-12], which has a range from 0 to 48. The higher the score, the greater the spiritual well-being. | 2 months |
| Participants' number of hospice enrollments | Number of hospice enrollments over time, up to 12 months. | up to 12 months |
| Participants' number of ICU admissions | Number of ICU admissions over time, up to 12 months. | up to 12 months |
| Patients' spiritual wellness as assessed by measures of satisfaction of spiritual care needs. | The satisfaction of spiritual care needs outcome measure for this trial is a reverse-coded total score for the 13-item Spiritual Needs Assessment for Patients [SNAP], which measures unmet spiritual care needs and has a range from 13 to 52. The higher the reverse-coded score, the greater the satisfaction of spiritual care needs. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' quality of life | The quality-of-life outcome measure for this trial is the total score for the 27-item Functional Assessment of Cancer Therapy - General [FACT-G], which has a range of 0 to 108. The higher the score, the greater the quality of life. | 2 months |
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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 | 646-962-7169 | pam2056@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul K Maciejewski, Ph.D. | Weill Medical College of Cornell University | Principal Investigator |
| Alan B Astrow, M.D. | NYP Brooklyn Methodist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Brooklyn Methodist Hospital | Recruiting | New York | New York | 11215 | United States |
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| M.D. Anderson Cancer Center |
| OTHER |
Patients will be assigned to "Spiritual Care Intervention #1" (active 1), "Spiritual Care Intervention #2" (active 2), or "Spiritual Care Intervention #3" (control) arm of the trial (overall ratio 1:1:1) using permuted-block randomization within strata defined by geographic location (NYC, Houston Metro Area) and recruitment site (NYC: BMH; Houston Metro Area: UTMB, MDACC).
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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 |
| Behavioral |
Experimental |
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| Spiritual Care Intervention #3 | Behavioral | Active Comparator |
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| Mukaila Raji, M.D. |
| The University of Texas Medical Branch |
| Principal Investigator |
| David Hui, M.D. | M.D. Anderson Cancer Center | Principal Investigator |
| The University of Texas Medical Branch, Galveston | Recruiting | Galveston | Texas | 77555 | United States |
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| M.D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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