Consumer-based meditation app, Calm, for treatment of sleep disturbance in hematological cancer patients

1 Hematological cancers, a group of cancer sub-types that include blood- and lymph-related disorders (i.e., 2 leukemia, lymphoma, myeloma, myeloproliferative neoplasms (MPNs) and myelodysplastic syndromes (MDS), 3 account for 11% of all cancer diagnoses in the US. Chronic hematological cancer (CHC) patients (i.e., chronic 4 leukemias, low grade lymphomas, myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms 5 [MPNs]) have extended disease courses that are often different from solid tumor cancers, facing chronic sleep 6 disturbances often associated with inflammation, fatigue, and emotional distress (anxiety and depression), which 7 often persist into survivorship. Medications are most commonly prescribed for cancer patients with sleep 8 disturbance; however, they often come with side effects and risk for long-term dependence. Cognitive behavioral 9 therapy for insomnia (CBT-I) is the most studied and first line of therapy for treating sleep disturbances in cancer 10 patients, but CBT-I is time-consuming, resource-intensive, and not easily accessible for all cancer patients. There 11 is a need for long-term, accessible, non-pharmacologic interventions targeting sleep in CHC patients. 12 Meditation is a safe and effective non-pharmacologic approach for improving a range of cancer-related 13 symptoms. However, meditation interventions have typically been delivered in-person, limiting uptake and 14 widespread dissemination due to patient-reported barriers. Smartphone applications (apps) are a novel 15 intervention approach for delivering meditation and address cancer patients’ barriers to participating in in-person 16 interventions (i.e., fatigue, pain, transportation, and scheduling difficulties) without the time and expertise 17 limitations of CBT-I and side effect risks from medication. Calm is a popular and highly reviewed consumer- 18 based smartphone app that provides an innovative, accessible and scalable platform through which to deliver 19 meditation to CHC patients. 20 We propose a double-blind RCT to determine the effectiveness of an eight-week “app-based wellness” 21 intervention (i.e., active daily meditation intervention [Calm] or the placebo health education podcast control 22 group [POD]) to reduce sleep disturbance (primary outcome), markers of inflammation (TNF-a, IL-6, IL-8, and 23 CRP) fatigue, and emotional distress (anxiety, depression) (secondary outcomes) in CHC patients. 24 Assessments will occur at baseline, post-intervention (eight weeks from baseline), and follow-up (20 weeks from 25 baseline). Participants (N=276) will be randomized to an intervention (10 min/day Calm meditation) (n=138) or 26 control (10 min/day health education podcast) group (n=138). We will remotely collect blood samples for 27 biomarker measurement. This study will fill a knowledge and rigor gap regarding the delivery of smartphone- 28 based meditation as an intervention for sleep and provide new data on sustained effects in CHC patients to 29 reduce sleep disturbance.