Pilot Trial of Spiritual Care Interventions for Patients With Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: Spiritual Care Intervention #1; Other: Spiritual Care Intervention #2

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madison K Pavao, B.S.; Phone Number: (646)962-5650; Email: mkp4005@med.cornell.edu
• Study Contact Backup: Name: Paul K Maciejewski, Ph.D.; Phone Number: (212) 746-2229; Email: pam2056@med.cornell.edu

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11215
      • Recruiting
      • New York Presbyterian Brooklyn Methodist Hospital
      • Contact: Madison K Pavao, B.S.; Phone Number: (646)962-5650; Email: mkp4005@med.cornell.edu
  • Texas
    • Galveston, Texas, United States, 77555
      • Recruiting
      • The University of Texas Medical Branch, Galveston
      • Contact: Madison K Pavao; Email: mkp4005@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spiritual Care Intervention #1; This is the experimental condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study.	Behavioral: Spiritual Care Intervention #1; Experimental
Active Comparator: Spiritual Care Intervention #2; This is the active comparator condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study.	Other: Spiritual Care Intervention #2; Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of Spiritual Well-Being as assessed by Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale [FACIT-Sp].	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.	2 months
Readiness to Engage in Advance Care Planning as assessed by the Advance Care Planning Engagement Survey.	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.	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of individual participants who complete a DNR order.	2 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); The University of Texas Medical Branch, Galveston; New York Presbyterian Brooklyn Methodist Hospital
• Investigators: Principal Investigator: Paul K Maciejewski, Ph.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 23-10026611; R21MD017652 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No