Advanced Cancer
Conditions
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.
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.
Interventions
BEHAVIORALSpiritual Care Intervention #1
Experimental
Active Comparator
Sponsors
Weill Medical College of Cornell University
New York Presbyterian Brooklyn Methodist Hospital
The University of Texas Medical Branch, Galveston
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Spiritual Well-Being as assessed by Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale [FACIT-Sp]. | 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. |
| Readiness to Engage in Advance Care Planning as assessed by the Advance Care Planning Engagement Survey. | 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
| Measure | Time frame |
|---|---|
| Number of individual participants who complete a DNR order. | 2 months |
Countries
United States
Contacts
CONTACTMadison K Pavao, B.S.
CONTACTPaul K Maciejewski, Ph.D.
PRINCIPAL_INVESTIGATORPaul K Maciejewski, Ph.D.
Weill Medical College of Cornell University
Outcome results
None listed