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Behavioural Intervention

Nite2Day+ for Blood Cancers

N/A
Waitlist Available
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 weeks), discharge (4 weeks), post-intervention (13 weeks), 1-month post-intervention (17 weeks)
Awards & highlights

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.

Who is the study for?
This trial is for hematologic cancer patients experiencing sleep disturbances and symptoms like fatigue, stress, and pain during/after inpatient treatment. Participants must be able to complete surveys and attend videoconference sessions post-treatment.
What is being tested?
The study tests Nite2Day+, a mindfulness intervention using a mobile app with meditations, sleep education videos, and strategies to improve sleep. It includes six videoconference sessions after hospital discharge for coping strategies.
What are the potential side effects?
Since the intervention involves non-invasive mindfulness practices and educational content without medication or medical procedures, significant side effects are not anticipated beyond potential discomfort from discussing personal experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0 weeks), discharge (4 weeks), post-intervention (13 weeks), 1-month post-intervention (17 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0 weeks), discharge (4 weeks), post-intervention (13 weeks), 1-month post-intervention (17 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability as measured by the Client Satisfaction Questionnaire (CSQ)
Change in insomnia symptoms
Engagement as measured by Nite2Day+ app and skills use
+3 more
Secondary study objectives
Change in anxiety symptoms
Change in depressive symptoms
Change in fatigue
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nite2Day+Experimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
Participants will receive written materials describing free services (e.g., legal and financial assistance, counseling) available through the Duke Cancer Patient Support Program.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,789 Previous Clinical Trials
40,986,235 Total Patients Enrolled
2 Trials studying Blood Cancers
110 Patients Enrolled for Blood Cancers
Duke UniversityLead Sponsor
2,408 Previous Clinical Trials
3,061,734 Total Patients Enrolled
~40 spots leftby Jun 2029