Mindfulness program to improve sleep and symptoms during and after hospital treatment for blood cancers
Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment
NA · Duke University · NCT06532773
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University (other) |
| Drugs / interventions | CAR-T, chemotherapy, immunotherapy |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06532773 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematologic Malignancy