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Recruiting Not applicable NCT06532773

Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment

No applicable phase (e.g. observational)
Conditions: Hematologic Malignancy

Sponsor: Duke University

trial.available_in: БГ
Overview
People with hematologic cancer often have sleep disturbance and symptoms of fatigue, stress, and pain. This study is being done to test a mindfulness intervention for sleep disturbance and symptom management in patients with hematologic cancer during and after inpatient treatment (Nite2Day+). Participants will complete a baseline survey online, using a mobile application, or paper/pencil. Once the baseline survey is complete, participants will be randomized (like a flip of a coin) to receive Nite2Day+ or Standard Care. Nite2Day+ will include activities during and after inpatient treatment. During inpatient treatment, participants will use a mobile app to access: 1) mindfulness meditations, 2) brief sleep education videos, and 3) brief videos teaching strategies to improve sleep quality in the hospital. After inpatient treatment, participants will complete 6, videoconference sessions (45-60 minutes) with a trained therapist to learn mindfulness and behavioral coping strategies to self-manage nighttime sleep disturbance and daytime symptoms of fatigue, stress, and pain. Three follow-up surveys will occur at hospital discharge, and approximately 8, and 12 weeks after hospital discharge. Participants randomized to Nite2Day+ will be given the option to complete an exit interview to provide feedback on the Nite2Day+ program. Participants randomized to Standard Care will only complete the four surveys. All participants will continue to receive their usual medical care. The total study duration is about 16 weeks.
Who can participate
Inclusion Criteria: 1. Male and female patients, \>18 years old 2. Initial or recurrent diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Non-Hodgkin's lymphoma, multiple myeloma, or myelodysplastic syndrome 3. at least 7 days of hospitalization for treatment (e.g., chemotherapy, CAR-T immunotherapy) 4. 8 or greater on the Insomnia Severity Index with timeframe adjusted to be "past 7 days" 5. Ability to speak and read English, and intact hearing and vision Exclusion Criteria: 1. Reported or suspected cognitive impairment, confirmed via Folstein Mini-Mental Status Exam \<25 2. Serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy) indicated by medical chart, oncologist, or other provider 3. Expected survival of \<6 months
Interventions
Nite2Day+
BEHAVIORAL
Locations 1
United States (1)
2400 Pratt Street
Durham , North Carolina
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
14.01.2026
Completion date
30.06.2029
Registry ID
NCT06532773
Source
clinicaltrials.gov
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