Pilot Trial of Spiritual Care Interventions for Patients With Cancer
Purpose
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
- Advanced Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosed with a life-limiting, advanced cancer. 2. Identifies racially as black or African American. 3. Is fluent in English.
Exclusion Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Active Comparator 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. |
|
Recruiting Locations
Galveston, Texas 77555
More Details
- Status
- Recruiting
- Sponsor
- Weill Medical College of Cornell University
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.