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NCT06532773 | NOT YET RECRUITING | Hematologic Malignancy

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

Duke University

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.

Condition or disease

Hematologic Malignancy

Intervention/treatment

Nite2Day+

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2029-06
Estimated Study Completion Date : 2029-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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. \>7 days of hospitalization for treatment (e.g., chemotherapy, CAR-T immunotherapy)
  • 4. \>8 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
Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment

Location Details

NCT06532773

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, North Carolina

2400 Pratt Street

Durham, North Carolina, United States, 27705