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Behavioural Intervention

Mindfulness Intervention 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

Initial or recurrent diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Non-Hodgkin's lymphoma, multiple myeloma, or myelodysplastic syndrome

More than 7 days of hospitalization for treatment (e.g., chemotherapy, CAR-T immunotherapy)

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

No Placebo-Only Group

Summary

This trial aims to test a mindfulness intervention called Nite2Day+ for managing sleep disturbance and symptoms in patients with hematologic cancer during and after inpatient treatment. Participants will complete a survey and then

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

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I have been diagnosed with a specific type of blood cancer.

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I was hospitalized for more than a week for treatments like chemotherapy.

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I scored over 8 on a recent sleep problem test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (0 weeks), discharge (4 weeks), post-intervention (13 weeks), 1-month post-intervention (17 weeks)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met