Spiritual Care Intervention in Adult Patients Diagnosed With Acute Leukemia

March 2, 2026 updated by: University of Chicago

Spiritual Care to Optimize Relationships and Experience in Adults With Acute Leukemia (SCORE Trial)

This study is being done to determine if it is possible to incorporate spiritual care sessions as part of the care plan for patients hospitalized for leukemia treatment. In this study, participants will be randomly assigned to either no intervention (standard, real world inpatient spiritual care) or to receive study-specific guided spiritual sessions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • UChicago Medicine Comprehensive Cancer Center
        • Principal Investigator:
          • Wendy Stock
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Adults (18 years or older)
  • Diagnosis of Acute Leukemia (AML or ALL) undergoing inpatient initial therapy
  • Ability to read, understand, and speak the English language
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

  • Unable to comply with spiritual care intervention
  • Relapsed or refractory acute leukemia
  • Cognitive deficits that limit participation and survey questionnaire completion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spiritual Intervention Arm
Participants receive a study specific spiritual care intervention.
Behavioral: SCORE Intervention
Participants assigned to this arm will receive regularly scheduled visits from the study spiritual care team during their hospital admission (four times within 14 days).
No Intervention: No Intervention Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is it feasible to enroll patients to a spiritual intervention study?
Time Frame: End of study (approximately 2 years)
Study will compare the number of potential participants to those that enroll and complete 3 out of 4 study intervention sessions.
End of study (approximately 2 years)
Will patients accept using the study specific spiritual intervention?
Time Frame: End of study (approximately 2 years)
This will be measured on using the Lothian Chaplaincy Patient Reported Outcome Measure (PROM) questionnaire. This measures patient feelings related to spiritual care using rating from not at all to all of the time.
End of study (approximately 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement on Patient Reported Spiritual Wellness
Time Frame: End of study (approximately 2 years)
This will be measured by improvement (higher scores) reported by participants on the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-sp12) questionnaire.
End of study (approximately 2 years)
Improvement on Patient Reported Quality of Life
Time Frame: End of study (approximately 2 years)
This will be measured by improvement (higher scores) reported by participants on the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) questionnaire.
End of study (approximately 2 years)
Improvement on Patient Reported Mood
Time Frame: End of study (approximately 2 years)
This will be measured by improvement (lower scores) reported by participants on the Hospital Anxiety and Depression Scale (HADS) questionnaire.
End of study (approximately 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Wendy Stock, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

June 16, 2028

Study Completion (Estimated)

June 16, 2028

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB25-0210

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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