NCT07405424

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable leukemia

Timeline
24mo left

Started Jun 2026

Shorter than P25 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 20, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2028

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

December 15, 2025

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Is it feasible to enroll patients to a spiritual intervention study?

    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?

    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 Outcomes (3)

  • Improvement on Patient Reported Spiritual Wellness

    End of study (approximately 2 years)

  • Improvement on Patient Reported Quality of Life

    End of study (approximately 2 years)

  • Improvement on Patient Reported Mood

    End of study (approximately 2 years)

Study Arms (2)

Spiritual Intervention Arm

EXPERIMENTAL

Participants receive a study specific spiritual care intervention.

Behavioral: SCORE Intervention

No Intervention Arm

NO INTERVENTION

Interventions

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).

Spiritual Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UChicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Wendy Stock

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2025

First Posted

February 12, 2026

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

June 16, 2028

Study Completion (Estimated)

June 16, 2028

Last Updated

March 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations