Mindfulness program to improve sleep and symptoms during and after hospital treatment for blood cancers
Official title: Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment
Run by Duke University · NCT06532773 · Data updated 2026-11-12
This study will test a mindfulness-based mobile app during hospitalization plus six follow-up video therapy sessions to help adults with hematologic cancers sleep better and manage fatigue, pain, and stress.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, immunotherapy |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | January 14, 2026 |
| Main results expected | June 30, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT06532773 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with an initial or recurrent hematologic malignancy who expect at least 7 days of hospitalization, have an Insomnia Severity Index score ≥8, and can read/speak English with intact hearing and vision are ideal candidates.
✕Probably not a fit
Patients with cognitive impairment, serious psychiatric or certain medical conditions, an expected survival under 6 months, or those unable to use a mobile app or videoconference sessions are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with hematologic malignancies are randomized to receive either the Nite2Day+ mindfulness intervention or standard care after completing a baseline survey. During hospitalization participants use a mobile app that provides mindfulness meditations, brief sleep education videos, and short strategies to improve sleep in the hospital. After discharge participants complete six 45–60 minute videoconference sessions with a trained therapist to learn mindfulness and behavioral coping strategies. Outcomes focus on sleep disturbance and symptom management during and after inpatient treatment.
Why it matters
Potential benefit: If successful, the program could improve sleep quality and reduce fatigue, pain, and stress for patients undergoing inpatient treatment for blood cancers.
How similar studies have gone: Previous research has shown mindfulness and behavioral interventions can improve sleep and symptoms in cancer populations, but combining an inpatient app with post-discharge therapist sessions like Nite2Day+ is a relatively novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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2400 Pratt Street
Durham, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Hannah M Fisher, PhD
- Email: hannah.fisher@duke.edu
- Phone: 919-416-3471
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.