NCT06811376

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Feb 2025Apr 2027

First Submitted

Initial submission to the registry

January 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

February 13, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

January 31, 2025

Last Update Submit

March 20, 2026

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Number of individual participants who complete a DNR order.

    2 months

Study Arms (2)

Spiritual Care Intervention #1

EXPERIMENTAL

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

Spiritual Care Intervention #2

ACTIVE COMPARATOR

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

Interventions

Spiritual Care Intervention #1BEHAVIORAL

Experimental

Spiritual Care Intervention #1
Spiritual Care Intervention #2OTHER

Active Comparator

Spiritual Care Intervention #2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

RECRUITING

The University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

RECRUITING

Study Officials

  • Paul K Maciejewski, Ph.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison K Pavao, B.S.

CONTACT

(646)962-5650mkp4005@med.cornell.edu

Paul K Maciejewski, Ph.D.

CONTACT

(212) 746-2229pam2056@med.cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 6, 2025

Study Start

February 13, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)