Trial of Spiritual Care Interventions for Patients With Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: Spiritual Care Intervention #1; Behavioral: Spiritual Care Intervention #2; Behavioral: Spiritual Care Intervention #3

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.

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madison K Pavao, B.S.; Phone Number: (646)962-5650; Email: mkp4005@med.cornell.edu
• Study Contact Backup: Name: Paul K Maciejewski, Ph.D.; Phone Number: 646-962-7169; Email: pam2056@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 11215
      • Recruiting
      • New York Presbyterian Brooklyn Methodist Hospital
      • Contact: Alan B Astrow, M.D.; Phone Number: (718) 780-5824; Email: ala9124@med.cornell.edu
      • Principal Investigator: Alan B Astrow, M.D.
  • Texas
    • Galveston, Texas, United States, 77555
      • Recruiting
      • The University of Texas Medical Branch, Galveston
      • Contact: Mukaila Raji, M.D.; Phone Number: (409) 772-1989; Email: muraji@UTMB.EDU
      • Principal Investigator: Mukaila Raji, M.D.
    • Houston, Texas, United States, 77030
      • Recruiting
      • M.D. Anderson Cancer Center
      • Contact: David Hui, M.D.; Phone Number: (713) 563-7630; Email: DHui@mdanderson.org
      • Principal Investigator: David Hui, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Spiritual Care Intervention #1; Experimental
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.	Behavioral: Spiritual Care Intervention #2; Experimental
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.	Behavioral: Spiritual Care Intervention #3; Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' spiritual wellness as assessed by measures of spiritual well-being	The spiritual well-being outcome measure for this trial is the total score for the 12-item Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale [FACIT-Sp-12], which has a range from 0 to 48. The higher the score, the greater the spiritual well-being.	2 months
Participants' number of hospice enrollments	Number of hospice enrollments over time, up to 12 months.	up to 12 months
Participants' number of ICU admissions	Number of ICU admissions over time, up to 12 months.	up to 12 months
Patients' spiritual wellness as assessed by measures of satisfaction of spiritual care needs.	The satisfaction of spiritual care needs outcome measure for this trial is a reverse-coded total score for the 13-item Spiritual Needs Assessment for Patients [SNAP], which measures unmet spiritual care needs and has a range from 13 to 52. The higher the reverse-coded score, the greater the satisfaction of spiritual care needs.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' quality of life	The quality-of-life outcome measure for this trial is the total score for the 27-item Functional Assessment of Cancer Therapy - General [FACT-G], which has a range of 0 to 108. The higher the score, the greater the quality of life.	2 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: M.D. Anderson Cancer Center; National Institute of Nursing Research (NINR); The University of Texas Medical Branch, Galveston; New York Presbyterian Brooklyn Methodist Hospital
• Investigators: Principal Investigator: Paul K Maciejewski, Ph.D., Weill Medical College of Cornell University; Principal Investigator: Alan B Astrow, M.D., NYP Brooklyn Methodist Hospital; Principal Investigator: Mukaila Raji, M.D., The University of Texas Medical Branch; Principal Investigator: David Hui, M.D., M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Cancer; Spiritual Care
• Other Study ID Numbers: 24-08027855; R01NR021159 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No