Pilot 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.
- 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 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.
Detailed description
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.
Interventions
- Behavioral Spiritual Care Intervention #1
Experimental - Other Spiritual Care Intervention #2
Active Comparator
Primary outcome measures
- Measure of Spiritual Well-Being as assessed by Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale [FACIT-Sp]. [Time frame: 2 months]
- Readiness to Engage in Advance Care Planning as assessed by the Advance Care Planning Engagement Survey. [Time frame: 2 months]
Secondary outcome measures (1)
- Number of individual participants who complete a DNR order. [Time frame: 2 months]
Eligibility criteria
Inclusion criteria
- Diagnosed with a life-limiting, advanced cancer.
- Identifies racially as black or African American.
- Is fluent in English.
Exclusion criteria
- Have received medical system-based spiritual care within the past 2 months.
- Have already completed a DNR order.
- Are 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 · 2 centers
- New York Presbyterian Brooklyn Methodist Hospital — Brooklyn
- The University of Texas Medical Branch, Galveston — Galveston
Identifiers
NCT: NCT06811376 · 23-10026611 · R21MD017652