Leukemia
Conditions
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.
Interventions
BEHAVIORALSCORE 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).
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Is it feasible to enroll patients to a spiritual intervention study? | 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? | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement on Patient Reported Spiritual Wellness | 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. |
| Improvement on Patient Reported Quality of Life | 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. |
| Improvement on Patient Reported Mood | 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. |
Countries
United States
Contacts
CONTACTClinical Trials Intake
PRINCIPAL_INVESTIGATORWendy Stock
University of Chicago
Outcome results
None listed