Trial of Spiritual Care Interventions for Patients With Cancer

Weill Cornell Medicine (WCM)

Status: Not yet enrolling

Conditions: Advanced Cancer

Treatments: Behavioral: Spiritual Care Intervention #1; Behavioral: Spiritual Care Intervention #2; Behavioral: Spiritual Care Intervention #3

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07408310

24-08027855

R01NR021159 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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288 participants in 3 patient groups

Spiritual Care Intervention #1

Experimental group

Description:

This is an 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

Experimental group

Description:

This is also an 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 #2

Spiritual Care Intervention #3

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:

Behavioral: Spiritual Care Intervention #3