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NCT06811376 | RECRUITING | Advanced Cancer

Pilot Trial of Spiritual Care Interventions for Patients With Cancer
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.

Condition or disease

Advanced Cancer

Intervention/treatment

Spiritual Care Intervention #1

Spiritual Care Intervention #2

Phase

NA

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
Estimated Enrollment : 64 participants
Masking : TRIPLE
Masking Description : 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.
Primary Purpose : SUPPORTIVE_CARE
Official Title : Pilot Trial of Spiritual Care Interventions for Patients With Cancer
Actual Study Start Date : 2025-02-13
Estimated Primary Completion Date : 2027-04-01
Estimated Study Completion Date : 2027-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Pilot Trial of Spiritual Care Interventions for Patients With Cancer

Location Details

NCT06811376

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States, 11215

RECRUITING

United States, Texas

The University of Texas Medical Branch, Galveston

Galveston, Texas, United States, 77555