Advanced Cancer
Conditions
Keywords
Advanced Cancer, Spiritual Care
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSpiritual Care Intervention #1
Experimental
BEHAVIORALSpiritual Care Intervention #2
Experimental
BEHAVIORALSpiritual Care Intervention #3
Active Comparator
Sponsors
Weill Medical College of Cornell University
National Institute of Nursing Research (NINR)
New York Presbyterian Brooklyn Methodist Hospital
The University of Texas Medical Branch, Galveston
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The participant's oncologist is the care provider who is masked. This masking is needed to ensure the scientific integrity of the trial.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with an advanced cancer. 2. Member of a religious faith community organization. 3. Fluent in English.
Exclusion criteria
1. Received spiritual care from a healthcare chaplain within the past 2 months. 2. Too weak or cognitively impaired to engage in study activities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients' spiritual wellness as assessed by measures of spiritual well-being | 2 months | 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. |
| Participants' number of hospice enrollments | up to 12 months | Number of hospice enrollments over time, up to 12 months. |
| Participants' number of ICU admissions | up to 12 months | Number of ICU admissions over time, up to 12 months. |
| Patients' spiritual wellness as assessed by measures of satisfaction of spiritual care needs. | 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' quality of life | 2 months | 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. |
Countries
United States
Contacts
CONTACTMadison K Pavao, B.S.
CONTACTPaul K Maciejewski, Ph.D.
PRINCIPAL_INVESTIGATORPaul K Maciejewski, Ph.D.
Weill Medical College of Cornell University
PRINCIPAL_INVESTIGATORAlan B Astrow, M.D.
NYP Brooklyn Methodist Hospital
PRINCIPAL_INVESTIGATORMukaila Raji, M.D.
The University of Texas Medical Branch
PRINCIPAL_INVESTIGATORDavid Hui, M.D.
M.D. Anderson Cancer Center
Outcome results
None listed