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NCT Number: NCT07408310

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.

Recruiting

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Brooklyn Methodist Hospital, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Diagnosed with an advanced cancer.
  • Member of a religious faith community organization.
  • Fluent in English.

Exclusion criteria

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

Treatment and study plan

Spiritual Care Intervention #1

Behavioral

Experimental

Spiritual Care Intervention #2

Behavioral

Experimental

Spiritual Care Intervention #3

Behavioral

Active Comparator

Primary outcomes

  1. Patients' spiritual wellness as assessed by measures of spiritual well-being

    Time frame: 2 months

    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. Participants' number of hospice enrollments

    Time frame: up to 12 months

    Number of hospice enrollments over time, up to 12 months.

  3. Participants' number of ICU admissions

    Time frame: up to 12 months

    Number of ICU admissions over time, up to 12 months.

  4. Patients' spiritual wellness as assessed by measures of satisfaction of spiritual care needs.

    Time frame: 2 months

    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.

Secondary outcomes

  1. Patients' quality of life

    Time frame: 2 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Madison K Pavao, B.S.

CONTACT

[email protected]

(646)962-5650

Paul K Maciejewski, Ph.D.

CONTACT

[email protected]

646-962-7169

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 13, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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