Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT04736056
Eligibility Criteria:
Inclusion Criteria:
* an initial or recurrent diagnosis of hematologic malignancy
* within 8 weeks of discharge home after inpatient chemotherapy or CAR-T therapy
* total score of 8 or greater on the Insomnia Severity Index (ISI)
* score of 5 or greater on the MD Anderson Symptom Inventory Scale for "worst" fatigue, pain, or distress, and report that these symptoms interfered with at least two activities of living (i.e., general activity, mood, work) in the last week at 3 or greater on a 0="Did not interfere" to 10="Interfered completely" scale
* ability to speak and read English, and hearing and vision that allows for completion of sessions and assessments
Exclusion Criteria:
* reported or suspected cognitive impairment subsequently informed by a Folstein Mini-Mental Status Examination of \<25
* presence of a serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy) indicated by medical chart, treating oncologist or other medical provider that would contraindicate safe participation
* expected survival of 6 months or less
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04736056
Study Brief:
Protocol Section:
NCT04736056