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Search / Trial NCT06532773

Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment

Launched by DUKE UNIVERSITY · Jul 29, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a program called Nite2Day+, which aims to help patients with hematologic cancers (like leukemia and lymphoma) manage sleep problems and other symptoms such as fatigue, stress, and pain during and after their hospital treatment. Participants will take an initial survey to assess their sleep issues, and then they will be randomly assigned to either receive the Nite2Day+ program or standard care. Those in the Nite2Day+ group will use a mobile app during their hospital stay to access mindfulness meditations and educational videos about sleep. After they leave the hospital, they will have six video sessions with a trained therapist to learn more techniques for managing their sleep and daytime symptoms.

To participate, individuals must be over 18 years old, have a diagnosis of specific blood cancers, and have been hospitalized for more than a week for treatment. They should also be experiencing significant sleep issues. Participants will complete several follow-up surveys to track their progress, and those in the Nite2Day+ group may also share their feedback about the program. Importantly, everyone in the study will continue to receive their usual medical care throughout the trial, which lasts about 16 weeks.

Gender

ALL

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

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported