NCT06532773 Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment
| NCT ID | NCT06532773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-01-14 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-01-14 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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. 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06532773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06532773 currently recruiting?
Yes, NCT06532773 is actively recruiting participants. Contact the research team at hannah.fisher@duke.edu for enrollment information.
Where is the NCT06532773 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06532773 clinical trial?
NCT06532773 is sponsored by Duke University. The trial plans to enroll 60 participants.