Trial of Spiritual Care Interventions for Patients With Cancer
Purpose
This study aims to determine the effects of 2 spiritual care interventions. Spiritual wellness and healthcare service utilization will be measured from a sample of advanced cancer patients recruited from outpatient settings.
Condition
- Advanced Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
1. Diagnosed with an advanced cancer.
2. Member of a religious faith community organization.
3. Fluent in English.
Exclusion Criteria:
1. Received spiritual care from a healthcare chaplain within the past 2 months.
2. Too weak or cognitively impaired to engage in study activities.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Patients will be assigned to "Spiritual Care Intervention #1" (active 1), "Spiritual Care Intervention #2" (active 2), or "Spiritual Care Intervention #3" (control) arm of the trial (overall ratio 1:1:1) using permuted-block randomization within strata defined by geographic location (NYC, Houston Metro Area) and recruitment site (NYC: BMH; Houston Metro Area: UTMB, MDACC).
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
- Masking Description
- 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 an experimental condition arm. Intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. |
|
|
Experimental Spiritual Care Intervention #2 |
This is also an 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 #3 |
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 study is a stratified permuted-block RCT to determine the effects of 2 spiritual care interventions on advanced cancer patients' spiritual wellness (i.e., spiritual well-being and satisfaction of spiritual care needs) and specific forms of healthcare service utilization (i.e., hospice enrollment and ICU admissions) in a sample of advanced cancer patients (N=288) recruited from outpatient settings. Patients will be assigned to "Spiritual Care Intervention #1" (active 1), "Spiritual Care Intervention #2" (active 2), or "Spiritual Care Intervention #3" (control) arm of the trial (overall ratio 1:1:1) using permuted-block randomization within strata defined by geographic location (NYC, Houston Metro Area) and recruitment site (NYC: BMH; Houston Metro Area: UTMB, MDACC). Spiritual care intervention details are being withheld until the trial concludes to protect the scientific integrity of the study. Only 1 of the 2 active interventions will be administered at each site at a given time to avoid within-site cross-contamination between the 2 active intervention arms of the trial.