Trial of Spiritual Care Interventions for Patients With Cancer

NCT07408310 | Not Yet Recruiting

• 2 other identifiers: 24-08027855R01NR021159
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

Advanced Cancer; Spiritual Care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Patients' quality of life

  2 months

Study Arms (3)

Spiritual Care Intervention #1

EXPERIMENTAL

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

Spiritual Care Intervention #2

EXPERIMENTAL

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

Spiritual Care Intervention #3

ACTIVE COMPARATOR

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

Interventions

Spiritual Care Intervention #3 BEHAVIORAL

Active Comparator

Spiritual Care Intervention #3

Spiritual Care Intervention #1 BEHAVIORAL

Experimental

Spiritual Care Intervention #1

Spiritual Care Intervention #2 BEHAVIORAL

Experimental

Spiritual Care Intervention #2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Received spiritual care from a healthcare chaplain within the past 2 months.
• Too weak or cognitively impaired to engage in study activities.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: collaborator
• M.D. Anderson Cancer Center: collaborator
• Weill Medical College of Cornell University: lead
• National Institute of Nursing Research (NINR): collaborator
• New York Presbyterian Brooklyn Methodist Hospital: collaborator

Study Sites (3)

New York Presbyterian Brooklyn Methodist Hospital

New York, New York, 11215, United States

Location

The University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison K Pavao, B.S.

CONTACT

(646)962-5650; mkp4005@med.cornell.edu

Paul K Maciejewski, Ph.D.

CONTACT

646-962-7169; pam2056@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participant's oncologist is the care provider who is masked. This masking is needed to ensure the scientific integrity of the trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)