Calm for Cancer Sleep Disturbance

NCT04345068 | Completed

• 1 other identifier: STUDY00011444
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Disturbance

  Sleep Disturbance will be measured with the NIH PROMIS Sleep Disturbance Adult Short Form. A higher score indicates more of the concept being measured.

  Change from baseline to mid-point (week 4), to post-intervention (week 8)

Secondary Outcomes (7)

• Change in Anxiety

  Change from baseline to mid-point (week 4), to post-intervention (week 8)

• Change in Depression

  Change from baseline to mid-point (week 4), to post-intervention (week 8)

• Change in Pain Intensity

  Change from baseline to mid-point (week 4), to post-intervention (week 8)

• Change in Global Health

  Change from baseline to mid-point (week 4), to post-intervention (week 8)

• Overall Quality of Life

  Change from baseline to mid-point (week 4), to post-intervention (week 8)

Other Outcomes (8)

• Sustained Effects on Sleep Disturbance

  Change from post-intervention (week 8) to follow-up (week 20)

• Sustained Effects on Depression

  Change from post-intervention (week 8) to follow-up (week 20)

• Sustained Effects on Anxiety

  Change from post-intervention (week 8) to follow-up (week 20)

Study Arms (2)

Calm Meditation

EXPERIMENTAL

The intervention will be 8-weeks in duration and will consist of a series of pre-approved meditation classes. Patients will be asked to participate in at least 10 min/day of meditation (i.e., \~70 min/week). Week 1-4 will consist of the "7 Days of Calm" followed by the "21 Days of Calm", which are introductory courses offered by Calm and provide basic, introductory meditation classes for beginners. Weeks 5-8 will consist of patients participating in the "Daily Calm" that Calm provides, consisting of 10-12 min meditation classes that have a unique focus each day. Patients will be instructed to participate in at least 10 min/day of meditation, but will be encouraged to do more if they can.

Behavioral: Calm Meditation Mobile App

Health Education Podcast

ACTIVE COMPARATOR

The control group will serve as an active control group and will be matched for time and attention to the intervention group. Participants assigned to the control group will be asked to listen to/view 10-min/day (i.e., \~70 min/week) of health education podcasts via a smartphone app. Topics covered in the health education control vary and will be aimed at providing useful and informative health-related information pertinent to cancer patients. The podcast app was developed by an independent app developer, and it was designed to mirror the type of functionality that the Calm app offers its users.

Behavioral: Health Education Podcast Mobile App

Interventions

Calm Meditation Mobile App BEHAVIORAL

The Calm app is downloadable by participants onto their smartphone. The Calm app is used to deliver the meditation intervention to experimental group participants.

Calm Meditation

Health Education Podcast Mobile App BEHAVIORAL

The health education podcast mobile app mirrors the intervention group's app experience, but provides educational content via podcasts as an active comparator.

Health Education Podcast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Arizona State University: lead
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be blinded as to which group is receiving the intervention being assessed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: August 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)