Calm for Cancer Sleep Disturbance

Completed · Not applicable

Conditions studied: Cancer

In brief

Cancer and cancer treatment often lead patients and survivors to experience a host of chronic symptoms, of which sleep disturbances are a major concern. Smartphone-based meditation via an already-developed app (i.e., Calm) is a unique and novel way of providing a potentially helpful symptom-management strategy to cancer patients and survivors. Our hypothesis is that cancer patients/survivors using the Calm smartphone app for eight weeks will see improved sleep disturbance (primary outcome) as well as anxiety, depression, pain intensity, global health, quality of life, emotional regulation, and mindfulness when compared to a time and attention-matched health education podcast control group. Cancer patients/survivors (n=300) will be randomly assigned to an intervention or control group for eight weeks, with study outcome measurement occurring at baseline, post-intervention (i.e., week eight), and follow-up (i.e., week 20).

Key facts

Study ID

NCT04345068

Run by

Arizona State University

People needed

150

Starts

2020-08-01

Expected to finish

2021-06-01

Last updated by the study team

2022-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Have a cancer diagnosis within the past 2 years
• self-identify as sleep disturbed (Pittsburgh Sleep Quality Index score of >5 indicating moderate sleep disturbance)
• own a mobile smartphone (iPhone with iOS 9.0 or later or an Android 4.1 or later)
• willing to download a mobile app
• able to read and understand English
• aged 18 years or older
• willing to be randomized to one of two groups
• no change in pharmacologic therapy over the past two weeks
• no change in sleep medication use (if any) over the past six weeks

You may not qualify if…

• meditation or meditative movement practice (i.e., yoga, tai chi, qigong) of greater than or equal to 60 min/month in the past six months
• use of any consumer-based meditation app
• reside outside of the United States
• any planned change in pharmacologic therapy or planned stem cell transplant during the study interval (i.e., 20 weeks)
• self-reported sleep-disordered breathing and/or sleep movement disorder

Where it is running

• Arizona State University — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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