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NCT Number: NCT06811376

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.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spiritual Care Intervention #1

Behavioral

Experimental

Spiritual Care Intervention #2

Other

Active Comparator

Primary outcomes

  1. Measure of Spiritual Well-Being as assessed by Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale [FACIT-Sp].

    Time frame: 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.

  2. Readiness to Engage in Advance Care Planning as assessed by the Advance Care Planning Engagement Survey.

    Time frame: 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 outcomes

  1. Number of individual participants who complete a DNR order.

    Time frame: 2 months

Study contacts

Contact information is provided by the study sponsor or research team.

Madison K Pavao, B.S.

CONTACT

[email protected]

(646)962-5650

Paul K Maciejewski, Ph.D.

CONTACT

[email protected]

(212) 746-2229

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • New York Presbyterian Brooklyn Methodist Hospital
  • The University of Texas Medical Branch, Galveston

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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