Pilot Trial of Spiritual Care Interventions for Patients With Cancer

NCT ID: NCT06811376

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-13

Study Completion Date

2027-04-01

Brief Summary

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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

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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.

Conditions

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Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Triple (Participant, Care Provider, Outcomes Assessor). The participant's oncologist is the care provider who is masked. This masking is needed to ensure the scientific integrity of the trial.

Study Groups

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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.

Group Type EXPERIMENTAL

Spiritual Care Intervention #1

Intervention Type BEHAVIORAL

Experimental

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.

Group Type ACTIVE_COMPARATOR

Spiritual Care Intervention #2

Intervention Type OTHER

Active Comparator

Interventions

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Spiritual Care Intervention #1

Experimental

Intervention Type BEHAVIORAL

Spiritual Care Intervention #2

Active Comparator

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York Presbyterian Brooklyn Methodist Hospital

OTHER

Sponsor Role collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul K Maciejewski, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

Site Status RECRUITING

The University of Texas Medical Branch, Galveston

Galveston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Madison K Pavao, B.S.

Role: CONTACT

(646)962-5650

Paul K Maciejewski, Ph.D.

Role: CONTACT

(212) 746-2229

Facility Contacts

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Madison K Pavao, B.S.

Role: primary

646-962-5650

Madison K Pavao

Role: primary

Other Identifiers

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R21MD017652

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-10026611

Identifier Type: -

Identifier Source: org_study_id

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