Status:
COMPLETED
Mindfulness and CBT for Sleep
Lead Sponsor:
Duke University
Conditions:
Hematologic Malignancy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with hematologic cancer frequently report significant difficulties with sleep in the months after discharge from inpatient chemotherapy. Poor sleep quality can contribute to and perpetuate pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2023
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04736056
Start Date
April 1 2021
End Date
May 19 2023
Last Update
December 2 2024
Active Locations (1)
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1
Duke Cancer Institute
Durham, North Carolina, United States, 27710