NCT06532773 · Duke University
Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Nite2Day+
Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
Primary outcome measures
Feasibility as measured by study accrual
Time frame: 24 months of study recruitment
Treatment feasibility will be shown by meeting targeted study accrual (N = 60 in 24 months).
Feasibility as measured by study attrition
Time frame: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Treatment feasibility will be shown by no more than 25% study attrition.
Feasibility as measured by adherence
Time frame: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Adherence will be indicated by at least 75% of study sessions and assessments completed.
Acceptability as measured by the Client Satisfaction Questionnaire (CSQ)
Time frame: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ. Items are rated on a 4-point scale from 1 (low) to 4 (high) and averaged to obtain an acceptability score ranging from 1 to 4, with higher scores indicating higher acceptability.
Engagement as measured by Nite2Day+ app and skills use
Time frame: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Engagement will be indicated by Nite2Day+ app log-in and skills practice at least 2 times per week.
Change in insomnia symptoms
Time frame: Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). Items are summed to yield a total score ranging from 0 to 28, with higher scores indicating worse insomnia symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and female patients, \>18 years old
- Initial or recurrent diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Non-Hodgkin's lymphoma, multiple myeloma, or myelodysplastic syndrome
- at least 7 days of hospitalization for treatment (e.g., chemotherapy, CAR-T immunotherapy)
- 8 or greater on the Insomnia Severity Index with timeframe adjusted to be "past 7 days"
- Ability to speak and read English, and intact hearing and vision
Exclusion criteria
- Reported or suspected cognitive impairment, confirmed via Folstein Mini-Mental Status Exam \<25
- Serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy) indicated by medical chart, oncologist, or other provider
- Expected survival of \<6 months
Where
- Durham, North Carolina
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations