Trial of Spiritual Care Interventions for Patients With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spiritual Care Intervention #1, Spiritual Care Intervention #2, Spiritual Care Intervention #3.
- Who it may be relevant to
- Registry conditions: Advanced Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Spiritual Care Intervention #1
Experimental - Behavioral Spiritual Care Intervention #2
Experimental - Behavioral Spiritual Care Intervention #3
Active Comparator
Primary outcome measures
- Patients' spiritual wellness as assessed by measures of spiritual well-being [Time frame: 2 months]
- Participants' number of hospice enrollments [Time frame: up to 12 months]
- Participants' number of ICU admissions [Time frame: up to 12 months]
- Patients' spiritual wellness as assessed by measures of satisfaction of spiritual care needs. [Time frame: 2 months]
Secondary outcome measures (1)
- Patients' quality of life [Time frame: 2 months]
Eligibility criteria
- Diagnosed with an advanced cancer.
- Member of a religious faith community organization.
- Fluent in English.
Exclusion criteria
- Received spiritual care from a healthcare chaplain within the past 2 months.
- Too weak or cognitively impaired to engage in study activities.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- New York Presbyterian Brooklyn Methodist Hospital — New York
- The University of Texas Medical Branch, Galveston — Galveston
- M.D. Anderson Cancer Center — Houston
Identifiers
NCT: NCT07408310 · 24-08027855 · R01NR021159