Pilot Trial of Spiritual Care Interventions for Patients With Cancer

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Advanced Cancer

Treatments: Behavioral: Spiritual Care Intervention #1; Other: Spiritual Care Intervention #2

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06811376

R21MD017652 (U.S. NIH Grant/Contract)

23-10026611

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Spiritual Care Intervention #1

Experimental group

Description:

This is the experimental condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study.

Treatment:

Behavioral: Spiritual Care Intervention #1

Spiritual Care Intervention #2

Active Comparator group

Description:

This is the active comparator condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study.

Treatment:

Other: Spiritual Care Intervention #2