Pilot Trial of Spiritual Care Interventions for Patients With Cancer

Not Applicable

Recruiting

• Conditions: Advanced Cancer

• Registration Number: NCT06811376
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Study Timeline

• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Study First Posted: 2025-02-06
• Study Start: 2025-02-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2027-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Diagnosed with a life-limiting, advanced cancer.
2. Identifies racially as black or African American.
3. Is fluent in English.

Exclusion Criteria

1. Have received medical system-based spiritual care within the past 2 months.
2. Have already completed a DNR order.
3. Are too weak or cognitively impaired to engage in study activities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measure of Spiritual Well-Being as assessed by Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale [FACIT-Sp].	2 months	The spiritual well-being outcome measure for this trial is the total score for the Spiritual Well-Being Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12-item Scale \[FACIT-Sp-12\], which has a range from 0 to 48. Higher scores mean greater spiritual well-being.
Readiness to Engage in Advance Care Planning as assessed by the Advance Care Planning Engagement Survey.	2 months	The readiness to engage in advance care planning outcome measure for this trial is the average score of 4 items in the 4-item version of the Advance Care Planning Engagement Survey. Each item as well as the average score of the 4 items have a range of 1 to 5. Higher scores mean greater readiness to engage in ACP.

Secondary Outcome Measures

Name	Time	Method
Number of individual participants who complete a DNR order.	2 months

Trial Locations

Locations (2)

New York Presbyterian Brooklyn Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

The University of Texas Medical Branch, Galveston; 🇺🇸 Galveston, Texas, United States