LeukemiaNCT07405424
Spiritual Care Intervention in Adult Patients Diagnosed With Acute Leukemia
A study testing SCORE Intervention in people with Leukemia, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- SCORE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2026to 16 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to comply with spiritual care intervention
- Relapsed or refractory acute leukemia
- Cognitive deficits that limit participation and survey questionnaire completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UChicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Wendy Stock
About this study
Official title: 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.
- Conditions
- Leukemia
- Being tested
- SCORE Intervention
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCORE InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Spiritual Intervention Arm | Experimental | Participants receive a study specific spiritual care intervention. Receives: Behavioral: SCORE Intervention |
| No Intervention Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: End of study (approximately 2 years)
Secondary outcomes (3)
Improvement on Patient Reported Spiritual Wellness
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.
Measured: End of study (approximately 2 years)
Improvement on Patient Reported Quality of Life
This will be measured by improvement (higher scores) reported by participants on the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) questionnaire.
Measured: End of study (approximately 2 years)
Improvement on Patient Reported Mood
This will be measured by improvement (lower scores) reported by participants on the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Measured: End of study (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start20 Jun 2026 (estimated)
- Primary completion16 Jun 2028 (estimated)
- Study completion16 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Stock, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405424
- Sponsor's protocol ID
- IRB25-0210
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spiritual Care to Optimize Relationships and Experience in Adults With Acute Leukemia (SCORE Trial)
- ClinicalTrials.gov ID
- NCT07405424
- Acronym / sponsor ID
- IRB25-0210
- Conditions
- Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 16 Jun 2028 (estimated)
- Study completion
- 16 Jun 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spiritual Intervention Arm | Experimental | Behavioral: SCORE InterventionParticipants receive a study specific spiritual care intervention. |
| No Intervention Arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to comply with spiritual care intervention
- Relapsed or refractory acute leukemia
- Cognitive deficits that limit participation and survey questionnaire completion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCORE InterventionParticipants assigned to this arm will receive regularly scheduled visits from the study spiritual care team during their hospital admission (four times within 14 days). | Behavioural | Spiritual Intervention Arm |
Primary outcome
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.
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.
3 secondary outcomes
Improvement on Patient Reported Spiritual Wellness
Time frame: End of study (approximately 2 years)
Improvement on Patient Reported Quality of Life
Time frame: End of study (approximately 2 years)
Improvement on Patient Reported Mood
Time frame: End of study (approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendy Stock principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCORE Intervention in people with Leukemia, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is it feasible to enroll patients to a spiritual intervention study? (time frame: End of study (approximately 2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.