Mindfulness Intervention for Blood Cancers

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Ability to speak and read English, and intact hearing and vision

I am over 18 years old.

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

See 2 more

Exclusion Criteria

Reported or suspected cognitive impairment, confirmed via Folstein Mini-Mental Status Exam less than 25

Serious psychiatric conditions (e.g., schizophrenia, suicidal intent) or medical conditions (e.g., seizure disorder, narcolepsy) indicated by medical chart, oncologist, or other provider

Expected survival of less than 6 months

Treatment Details

Interventions

Nite2Day+ (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.