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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Behavioral: Nite2Day+

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah M Fisher, PhD; Phone Number: 919-416-3471; Email: hannah.fisher@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • 2400 Pratt Street
      • Contact: Hannah M Fisher; Phone Number: 919-416-3471; Email: hannah.fisher@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nite2Day+; 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.	Behavioral: Nite2Day+; Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.; Other Names: Mindfulness Based Therapy for Insomnia; Cognitive Behavioral Symptom Coping Skills
No Intervention: Usual Care; Participants will receive written materials describing free services (e.g., legal and financial assistance, counseling) available through the Duke Cancer Patient Support Program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as measured by study accrual	Treatment feasibility will be shown by meeting targeted study accrual (N = 60 in 24 months).	24 months of study recruitment
Feasibility as measured by study attrition	Treatment feasibility will be shown by no more than 25% study attrition.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Feasibility as measured by adherence	Adherence will be indicated by at least 75% of study sessions and assessments completed.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Acceptability as measured by the Client Satisfaction Questionnaire (CSQ)	Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ. Items are rated on a 4-point scale from 1 (low) to 4 (high) and averaged to obtain an acceptability score ranging from 1 to 4, with higher scores indicating higher acceptability.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Engagement as measured by Nite2Day+ app and skills use	Engagement will be indicated by Nite2Day+ app log-in and skills practice at least 2 times per week.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Change in insomnia symptoms	Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). Items are summed to yield a total score ranging from 0 to 28, with higher scores indicating worse insomnia symptoms.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatigue	Fatigue symptoms will be assessed using the 8-item PROMIS Fatigue Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicated higher fatigue.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Change in pain severity	Pain severity will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 4 items assessing pain severity, including worst, least, average, and current pain in the past week. Responses range from 0 (no pain) to 10 (pain as bad as you can imagine); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain severity.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Change in pain interference	Pain interference will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 7 items assessing the degree to which pain has interfered with patients' daily activities in the past week. Responses range from 0 (does not interfere) to 10 (completely interferes); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain interference.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Change in depressive symptoms	Depressive symptoms will be assessed using the 8-item PROMIS Depression Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate higher worse depressive symptoms.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Change in anxiety symptoms	Anxiety symptoms will be assessed using the 8-item PROMIS Anxiety Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate worse anxiety symptoms.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Change in mindfulness	Mindfulness will be assessed using the 10-item Cognitive and Affective Mindfulness Scale - Revised. Participants will be asked to rate their level of mindfulness across two domains (cognitive and affective) using a 4-point response scale ranging from 1 (rarely/not at all) to 4 (almost always). Items are summed to yield a total score, with higher scores reflecting greater mindfulness.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Change in self-efficacy for symptom management	Self-efficacy for symptom management will be assessed using the 8-item PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms Scale. Participants will rate their confidence in managing their symptoms using a 5-point response scale from 1 (I am not at all confident) to 5 (I am very confident). Items are summed and converted to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate better self-efficacy for symptom management.	Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: Pro00115799; K08CA283026 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No