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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
288
Experimental
Experimental
Active Comparator
New York Presbyterian Brooklyn Methodist Hospital
New York, New York, United States
The University of Texas Medical Branch, Galveston
Galveston, Texas, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
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.
Time frame: 2 months
Participants' number of hospice enrollments
Number of hospice enrollments over time, up to 12 months.
Time frame: up to 12 months
Participants' number of ICU admissions
Number of ICU admissions over time, up to 12 months.
Time frame: 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.
Time frame: 2 months
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.
Time frame: 2 months
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