Calm for Cancer Sleep Disturbance

NCT ID: NCT04345068

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-06-01

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).

Detailed Description

Cancer patients and survivors struggle with chronic symptom burden, including sleep disturbance, fatigue, depressive symptoms, and anxiety, among others. Sleep disturbance is one of the most common complaints among cancer patients and survivors (reported in as many as 85% of cancer patients and survivors, depending on the type of cancer), but is often not fully addressed by pharmacologic intervention alone. Therefore, cancer patients and survivors often turn to non-pharmacologic approaches.

Currently, cognitive behavioral therapy for insomnia (CBT-I) is the most available, evidence-based, non-pharmacologic treatment strategy to manage sleep disturbances in cancer patients and survivors. However, this treatment modality is time-consuming and intensive, requiring patients to frequently meet in-person with therapists and physicians at sites/clinics. This approach may not be sustainable in the long term, as cancer patients often report barriers to attending in-person interventions, including fatigue, transportation, and scheduling difficulties. Although remote delivery of CBT-I has been suggested as an alternative,1 only a single pilot study has investigated this possibility. The pilot study delivered CBT-I via a mobile app, but was limited by the small sample size (n=19) and no control group. Further research is needed testing the delivery of efficacious, non-pharmacologic interventions remotely to cancer patients and survivors for the management of sleep disturbance.

Smartphones, due to their increasing ubiquity among cancer patients and survivors, offer a novel medium through which to deliver non-pharmacologic sleep-management interventions. In a recent survey of 1,300 cancer patients, 71% reported owning a mobile smartphone. A 2018 survey of 631 cancer patients demonstrated that 74% regularly use a smartphone, and 39% expressed an interest in supportive care information via mobile apps. Meditation is a non-pharmacologic intervention that has a growing body of literature to document its benefits for sleep in cancer patients, and it is a less time-consuming and resource-intensive strategy when compared to CBT-I. Further research needs to examine the potential efficacy of meditation as an efficacious non-pharmacologic strategy for the self-management of sleep disturbances.

The investigators have successfully delivered meditation to hematological cancer patients previously via the Calm app with moderate effects demonstrated on sleep disturbance. However, more research is needed to test the preliminary effects of smartphone-based meditation among cancer patients for sleep disturbance as compared to an active control group. In the proposed study, the investigators will recruit a national sample of cancer patients and survivors (N=300) within two years of cancer diagnosis, to pilot test an eight-week smartphone-based meditation intervention (i.e., Calm; n=150) on sleep disturbance (primary outcome) as compared to a smartphone-based health education podcast control group (n=150). The investigators will aim to recruit 50% men into the study.

STUDY OBJECTIVES

Objective 1: Explore the preliminary effects of eight weeks of daily meditation delivered using the Calm app on sleep disturbance in cancer patients and survivors within two years of diagnosis as compared to a smartphone-based podcast control group.

The primary hypothesis for this objective is that those in the Calm group will experience improvements in sleep disturbance greater than those experienced by the podcast control group at eight weeks.

Objective 2: Explore the preliminary effects of eight weeks of daily meditation delivered using the Calm app on cancer patients and survivors within two years of diagnosis on anxiety, depression, pain intensity, global health, quality of life, emotional regulation, and mindfulness as compared to a smartphone-based podcast control group.

The primary hypothesis for this objective is that those in the Calm app group will experience improvements in anxiety, depression, pain intensity, global health, quality of life, emotional regulation, and mindfulness greater than those experienced by the podcast control group at eight weeks.

Exploratory Objective 3: Explore the sustained effects of meditation delivered using the Calm app on cancer patients and survivors (i.e., 12-week follow-up).

The primary hypothesis for this objective is that those in the Calm app group will experience improvements across outcomes compared to baseline that are sustained at 20 weeks.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Calm Meditation

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.

Group Type: EXPERIMENTAL

Calm Meditation Mobile App

Intervention Type: 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.

Health Education Podcast

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.

Group Type: ACTIVE_COMPARATOR

Health Education Podcast Mobile App

Intervention Type: BEHAVIORAL

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

Interventions

Calm Meditation Mobile App

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

Intervention Type: BEHAVIORAL

Health Education Podcast Mobile App

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

STUDY00011444

Identifier Type: -

Identifier Source: org_study_id