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

Duke University

Status: Enrolling

Conditions: Hematologic Malignancy

Treatments: Behavioral: Nite2Day+

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06532773

Pro00115799

K08CA283026 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Nite2Day+

Experimental group

Description:

During inpatient treatment, Nite2Day+ will be delivered via a self-paced mobile app. Participants will use the app to access: 1) mindfulness meditations (e.g., Body Scan, 3-Minute Mini-Meditation) from Mindfulness Based Therapy for Insomnia (MBTI); 2) brief, 3-5 minute sleep education videos (i.e., 3-P Model of Insomnia, sleep hygiene, sleep drive, circadian rhythm) specifically tailored to the inpatient setting; and 3) brief, 3-5 minute videos teaching behavioral strategies (e.g., stimulus control, daytime activity, light exposure, communication with medical team) to improve sleep quality in the hospital. After inpatient treatment, Nite2Day+ will deliver a six session (45-60 minutes), therapist-led, Zoom protocol. Participants will learn new mindfulness-based sleep strategies (e.g., sleep consolidation, sleep reconditioning), meditations (e.g., Sitting Meditation), and behavioral symptom coping skills.

Treatment:

Behavioral: Nite2Day+

Usual Care

No Intervention group

Description:

Participants will receive written materials describing free services (e.g., legal and financial assistance, counseling) available through the Duke Cancer Patient Support Program.