Clinical trial NCT04345068: Calm for Cancer Sleep Disturbance
Official title: A Pilot Study of Calm for Cancer Patient Sleep Disturbance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
First posted: 2020-04-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Sleep Disturbance
timeFrame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Secondary outcomes:
measure: Change in Anxiety
timeFrame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
measure: Change in Depression
timeFrame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
measure: Change in Pain Intensity
timeFrame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
measure: Change in Global Health
timeFrame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
measure: Overall Quality of Life
timeFrame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
measure: Emotional Regulation
timeFrame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
measure: Mindfulness
timeFrame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Other outcomes:
measure: Sustained Effects on Sleep Disturbance
timeFrame: Change from post-intervention (week 8) to follow-up (week 20)
measure: Sustained Effects on Depression
timeFrame: Change from post-intervention (week 8) to follow-up (week 20)
measure: Sustained Effects on Anxiety
timeFrame: Change from post-intervention (week 8) to follow-up (week 20)
measure: Sustained Effects on Pain Intensity
timeFrame: Change from post-intervention (week 8) to follow-up (week 20)
measure: Sustained Effects on Global Health
timeFrame: Change from post-intervention (week 8) to follow-up (week 20)
measure: Sustained Effects on Overall Quality of Life
timeFrame: Change from post-intervention (week 8) to follow-up (week 20)
measure: Sustained Effects on Emotional Regulation
timeFrame: Change from post-intervention (week 8) to follow-up (week 20)
measure: Sustained Effects on Mindfulness
timeFrame: Change from post-intervention (week 8) to follow-up (week 20)
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References: