Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 25, 2022
Date Accepted: Jun 3, 2022
Insomnia as an Unmet Need in Chronic Hematologic Cancer Patients: A study design of a randomized controlled trial evaluating a consumer-based meditation app for treatment of sleep disturbance
ABSTRACT
Background:
To address the need for long-term, accessible, non-pharmacologic interventions targeting sleep in chronic hematological cancer patients, we propose the first randomized controlled trial to determine the effects of a consumer-based mobile meditation app (i.e., Calm) on sleep disturbance in this population.
Objective:
The purpose of this study is to: (1) test the efficacy of daily meditation delivered via Calm compared to a health education podcast control group in improving the primary outcome of self-reported sleep disturbance as well as secondary sleep outcomes including sleep impairment and sleep efficiency; (2) test the efficacy of daily meditation delivered via Calm compared to a health education podcast control group on inflammatory markers, fatigue, and emotional distress; and (3) explore free-living use during a 12-week follow up period and sustained effects of Calm in chronic hematological cancer patients.
Methods:
In a double blind randomized controlled trial, we will recruit a total of 276 chronic hematological cancer patients to an 8-week “app-based wellness” intervention: the active daily app-based meditation intervention or the health education podcast app control group, followed by a 12-week follow-up period. Participants will be asked to: (1) use their assigned app for at least 10 minutes/day during the 8-week intervention period, (2) complete online surveys assessing self-reported sleep disturbance, fatigue, and emotional distress at baseline, 8-weeks, and 20-weeks, (3) complete sleep diaries and wear an actigraphy device during the 8-week intervention period and at 20-weeks, and (4) complete blood draws to assess inflammatory markers (i.e., TNF-a, IL-6, IL-8, CRP) at baseline, 8-weeks, and 20-weeks.
Results:
N/A
Conclusions:
This project is scheduled to begin recruitment in April 2022, with the total project duration lasting five years. This research will contribute to broader public health efforts by providing researchers and clinicians with an evidence based commercial product to improve sleep long term in an underserved and understudied cancer population with a high incidence of sleep disturbance. Clinical Trial: NCT05294991; Date registered: March 24, 2022; https://clinicaltrials.gov/ct2/show/NCT05294991
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