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Trial Title:
Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment
NCT ID:
NCT06532773
Condition:
Hematologic Malignancy
Conditions: Official terms:
Hematologic Neoplasms
Dyssomnias
Parasomnias
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Nite2Day+
Description:
Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
Arm group label:
Nite2Day+
Other name:
Mindfulness Based Therapy for Insomnia
Other name:
Cognitive Behavioral Symptom Coping Skills
Summary:
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.
Criteria for eligibility:
Criteria:
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. >7 days of hospitalization for treatment (e.g., chemotherapy, CAR-T immunotherapy)
4. >8 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
2400 Pratt Street
Address:
City:
Durham
Zip:
27705
Country:
United States
Start date:
July 2025
Completion date:
June 2029
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06532773
