Consumer-based meditation app, Calm, for treatment of sleep disturbance in hematological cancer patients
Project Number5R01CA262041-04
Former Number1R01CA262041-01A1
Contact PI/Project LeaderHUBERTY, JENNIFER LYNNE Other PIs
Awardee OrganizationUNIVERSITY OF TEXAS HLTH SCIENCE CENTER
Description
Abstract Text
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.
Public Health Relevance Statement
Project Narrative
Chronic hematological cancer (CHC) patients are characterized by long term and high symptom burden,
including up to 65% reporting chronic sleep disturbances that are also often associated with inflammation,
fatigue, and emotional distress (anxiety and depression). Meditation is an effective non-pharmacologic strategy
to self-manage and improve cancer-related symptoms and mediation delivered via mobile applications may
address cancer patients’ barriers to in-person interventions (i.e., fatigue, pain, transportation, scheduling
difficulties) without the time and expertise limitations of cognitive behavioral therapy for insomnia (CBT-I) and
side effect risks from medication. This study is the first to test a commercially available, smartphone-based
meditation application to self-manage sleep disturbance, inflammation fatigue, and emotional distress (anxiety,
depression), among CHC patients and to explore the sustained effects of meditation compared to a health
education podcast control group.
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