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NCT Number: NCT07405424

Spiritual Care Intervention in Adult Patients Diagnosed With Acute Leukemia

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UChicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

SCORE Intervention

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 12, 2026
Registry last updated
Mar 4, 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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