CancerNCT04345068
Calm for Cancer Sleep Disturbance
A study testing Calm Meditation Mobile App and Health Education Podcast Mobile App in people with Cancer, run by Arizona State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Calm Meditation Mobile App and Health Education Podcast Mobile App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Calm for Cancer Patient Sleep Disturbance
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).
Read the 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
- Being tested
- Calm Meditation Mobile App, Health Education Podcast Mobile App
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm Meditation Mobile AppBehavioural
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 Mobile AppBehavioural
The health education podcast mobile app mirrors the intervention group's app experience, but provides educational content via podcasts as an active comparator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health Education Podcast Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Secondary outcomes (7)
Change in Anxiety
Anxiety will be measured with the NIH PROMIS Anxiety Short Form. A higher score indicates more of the concept being measured.
Measured: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Change in Depression
Depression will be measured with the NIH PROMIS Depression Adult Short Form. A higher score indicates more of the concept being measured.
Measured: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Change in Pain Intensity
Pain Intensity will be measured with the NIH PROMIS Pain Intensity Adult Short Form. A higher score indicates more of the concept being measured.
Measured: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Change in Global Health
Global Health will be measured with the NIH PROMIS Global Health. A higher score indicates more of the concept being measured.
Measured: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Overall Quality of Life
Overall Quality of Life will be measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQC30). A higher score indicates more of the concept being measured.
Measured: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Emotional Regulation
Emotional Regulation will be measured with the Difficulties in Emotion Regulation Scale Short Form. This form is an 18-item measure used to identify emotional regulation issues in adults. The measure covers 4 dimensions of emotional regulation: awareness and understanding of emotions; acceptance of emotions; the ability to engage in goal-directed behavior and refrain from impulsive behavior when experiencing negative emotions; and access to emotion regulation strategies perceived as effective. The measure has six subscales: Nonacceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. A higher score indicates greater difficulties in emotional regulation.
Measured: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Mindfulness
Mindfulness will be measured with the Mindful Attention Awareness Scale (MAAS). The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness. Higher scores reflect higher levels of dispositional mindfulness.
Measured: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Aug 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345068
- Sponsor's protocol ID
- STUDY00011444
- Status last verified
- Feb 2022
- First submitted
- 9 Apr 2020
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Calm for Cancer Patient Sleep Disturbance
- ClinicalTrials.gov ID
- NCT04345068
- Acronym / sponsor ID
- STUDY00011444
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calm Meditation | Experimental | Behavioral: Calm Meditation Mobile AppThe 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. |
| Health Education Podcast | Active comparator | Behavioral: Health Education Podcast Mobile AppThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calm Meditation Mobile AppThe Calm app is downloadable by participants onto their smartphone. The Calm app is used to deliver the meditation intervention to experimental group participants. | Behavioural | Calm Meditation |
| Health Education Podcast Mobile AppThe health education podcast mobile app mirrors the intervention group's app experience, but provides educational content via podcasts as an active comparator. | Behavioural | Health Education Podcast |
Primary outcome
Change in Sleep Disturbance
Time frame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Sleep Disturbance will be measured with the NIH PROMIS Sleep Disturbance Adult Short Form. A higher score indicates more of the concept being measured.
7 secondary outcomes
Change in Anxiety
Time frame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Change in Depression
Time frame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Change in Pain Intensity
Time frame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Change in Global Health
Time frame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Overall Quality of Life
Time frame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Emotional Regulation
Time frame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Mindfulness
Time frame: Change from baseline to mid-point (week 4), to post-intervention (week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calm Meditation Mobile App and Health Education Podcast Mobile App in people with Cancer, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Disturbance (time frame: Change from baseline to mid-point (week 4), to post-intervention (week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.