Myeloproliferative NeoplasmNCT03726944
The Feasibility of Delivering Consumer-based Meditation Applications to Myeloproliferative Neoplasm Patients
A study testing Calm App Meditation and Unnamed Consumer-Based App Meditation in people with Myeloproliferative Neoplasm, run by Arizona State University at 1 site in United States.
Trial summary
This study was a four-group randomized pilot trial in myeloproliferative neoplasm (MPN) patients. Patients were recruited nationally through organizational partners and social media. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- What is being tested?
- Calm App Meditation and Unnamed Consumer-Based App Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2017to 2 Apr 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- had a diagnosis of MPN (i.e., essential thrombocythemia, polycythemia vera, or myelofibrosis) identified by treating physician
- owned a mobile smartphone and were willing to download and use a meditation app (i.e., CB or Calm)
- could read and understand English
- were age 18 years or older
- were willing to be randomized to one of four groups: 1) CB 4 wks/Calm 4 wks, 2) Calm 4 wks/CB 4 wks, 3) educational material 4 wks/CB 4 wks, and 4) educational material 4 wks/Calm 4 wks,
Who cannot join
- engaged in ≥10 min/day of meditation on ≥5 days/week for the past 6 months
- engaged in ≥60 min/week of tai chi, qigong, or yoga each week
- utilized either App #1 or Calm
- resided outside of the United States of America
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
Official title: Feasibility of Using a Consumer-based Mobile App to Improve Fatigue and Emotional Symptoms in Myeloproliferative Neoplasm Patients
This study was a four-group randomized pilot trial in myeloproliferative neoplasm (MPN) patients. Patients were recruited nationally through organizational partners and social media. Eligible and consented patients were enrolled into one of four groups, two of which received varying orders of two consumer-based apps (unnamed consumer-based [CB] app and Calm App) and two that received one of the apps alone for the second four weeks of the eight week intervention after an educational control condition. Participants were asked to perform 10 min/day of smartphone-based meditation irrespective of the app and/or the order in which they received the apps. Feasibility outcomes were measured at week five and nine with an online survey. Feasibility outcomes were acceptability, demand, and limited efficacy for depression, anxiety, pain intensity, sleep disturbance, sexual function, quality of life, global health, and total symptom burden. The purpose of this study was to examine the feasibility of the use of two different consumer-based meditation smartphone applications (i.e., apps) in MPN patients.
Specific aim #1: Examine the feasibility of daily meditation delivered using a consumer-based mobile app. Hypothesis: It will feasible to deliver smartphone-based meditation to MPN patients.
Exploratory Aim: Explore the preliminary effects of daily meditation delivered using a consumer-based mobile app on MPN self-report fatigue, anxiety, depression, pain intensity, sleep disturbance, sexual function, global health, quality of life, and total symptom burden. Hypothesis: There will be demonstrated preliminary effects on patient-reported outcomes in MPN patients.
Read the detailed description
This was a four-group, randomized controlled trial with a cross-over design. Patients were enrolled into one of four groups with varying order of receiving two consumer-based meditation smartphone (i.e., unnamed consumer-based app [CB app], Calm app) apps in 4-week increments over eight weeks. Group #1 received the CB App followed by the Calm app; Group #2 received the Calm app followed by the CB app; Group #3 received educational control followed by the CB app and Group #4 received educational control followed by the Calm app.
MPN patients were recruited online through MPN organizational partners with a single page, broad overview of the study and its requirements. The study was advertised as a smartphone app meditation study. MPN patients interested in the study were asked to complete an online eligibility questionnaire administered via Qualtrics. Researchers then checked completed eligibility questionnaires as they were completed and emailed patients with their eligibility status.
If ineligible, patients received an email stating their ineligibility status as well as links to both consumer-based apps used in the study in case the ineligible participant was interested in trying meditation. Eligible patients were invited to participate in a 20-minute phone appointment in which the study details and informed consent were described in detail. MPN patients who completed the intake appointment were then sent an informed consent electronically via Qualtrics that included a place for their electronic signature.
Upon receipt of the completed informed consent, participants were randomly assigned to one of four groups. A group assignment list was generated prior to study commencement with randomizer.org. This pre-generated list was then used by research personnel to place eligible, consented MPN patients into their group assignment (i.e., Group #1, Group #2, Group #3, Group #4; described below) in the order in which they consented to participate. Randomized participants were provided with a "welcome email" that contained a) a welcome letter introducing them to the study, b) a calendar detailing important study dates, c) instructions specific to the first assigned condition (i.e., CB app, Calm app, or educational control) to be introduced for the first four weeks. After participants completed the first of their two, four-week conditions (i.e., CB App, Calm, or control), they were provided with another email that included instructions specific to their final condition (i.e., CB app, Calm app, or educational control).
Unnamed Consumer-Based (CB) App The CB app was an already existing consumer-based smartphone app. The first and second week consisted of meditation that was basic introductory, and educational for those new to meditation. Weeks three and four consisted of a new and unique daily meditation that study participants could select from a library of meditations within the app. Each of the daily meditations had a different focus (e.g., grief, gratitude, choice, letting go, etc.) and were ~10-12 minutes in length.
Description of Conditions
Calm App The Calm app was an already-existing, consumer-based meditation app. The first week of the intervention included the "7 Days of Calm", which consists of seven days of introductory meditations that incorporated basic, educational information for those new to meditation while introducing brief experiential practices within that short period of time. Weeks two through four consisted of the "Daily Calm", which is a new and unique daily guided meditation that was provided by the app. Each of the daily meditations had a different focus (e.g., practicing patience, loving-kindness, gratitude, etc.) and were ~10-12 minutes in length.
Educational Control The control condition was provided with educational material handout that was developed by the research team prior to the study. The handout addressed MPN patient fatigue (e.g., What causes fatigue?) as well as examples of and information related to evidence-based fatigue-management strategies.
Description of Groups
Group #1 (CB App + Calm) Group #1 was assigned the CB App (Weeks 1-4) and the Calm app (Weeks 5-8). During weeks 1-4, participants were asked to complete four weeks of meditation on the CB App via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could. During weeks 5-8, participants were asked to complete four weeks of meditation on the Calm app via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could.
Group #2 (Calm APP + CB App) Group #2 was assigned the Calm app (Weeks 1-4) and the CB app (Weeks 5-8). During weeks 1-4, participants were asked to complete four weeks of meditation on the Calm app via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could. During weeks 5-8, participants were asked to complete four weeks of meditation on the CB app via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could.
Group #3 (Control + CB App) Group #3 was assigned educational control (Weeks 1-4) and the CB app (Weeks 5-8). During weeks 1-4, participants were provided the educational material handout and asked to maintain their normal routine. During weeks 5-8, participants were asked to complete four weeks of meditation on the CB app via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could.
Group #4 (Control + Calm) Group #4 was assigned educational control (Weeks 1-4) and the Calm app (Weeks 5-8). During weeks 1-4, participants were provided the educational material handout and asked to maintain their normal routine. During weeks 5-8, participants were asked to complete four weeks of meditation on the Calm app via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could.
All study participants completed patient-reported outcomes measures via an online questionnaire at baseline (week 0), mid-point (week 5), and post-intervention (week 9).
- Conditions
- Myeloproliferative Neoplasm
- Being tested
- Calm App Meditation, Unnamed Consumer-Based App Meditation, Educational Control
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm App MeditationBehavioural
The Calm app intervention consisted of 10 min/day of meditation for 4 weeks via the Calm smartphone app.
Unnamed Consumer-Based App MeditationBehavioural
The unnamed consumer-based app intervention consisted of 10 min/day of meditation for 4 weeks via an unnamed consumer-based meditation smartphone app.
Educational ControlOther
The educational control consisted of an educational handout that was provided to participants. This control lasted for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Meditation1+Meditation2 | Other | 8 weeks in total; 4 weeks of unnamed consumer-based meditation app + 4 weeks of Calm meditation app Receives: Behavioral: Calm App Meditation; Behavioral: Unnamed Consumer-Based App Meditation |
| Group 2 - Meditation2+Meditation1 | Other | 8 weeks in total; 4 weeks of Calm meditation app + 4 weeks of unnamed consumer-based meditation app Receives: Behavioral: Calm App Meditation; Behavioral: Unnamed Consumer-Based App Meditation |
| Group 3 - Control+Meditation1 | Other | 8 weeks in total; 4 weeks of educational control + 4 weeks of unnamed consumer-based meditation app Receives: Behavioral: Unnamed Consumer-Based App Meditation; Other: Educational Control |
| Group 4 - Control+Meditation2 | Other | 8 weeks in total; 4 weeks of educational control + 4 weeks of Calm meditation app Receives: Behavioral: Calm App Meditation; Other: Educational Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention: survey
Acceptability was measured with a satisfaction survey. Benchmarks for acceptability included ≥70% response to the following questions in the survey: 1) satisfaction with the apps' content, 2) intending to continue using the app, 3) enjoying using the apps, and 4) recommending it for other MPN patients. The % of participants indicating responses to the four prior questions will be considered "acceptable" if all four questions are responded to with a ≥70% response rate.
Measured: Change from Baseline to Week 5 and Week 9
Demand of Meditation
Demand was measured using adherence to the meditation intervention. Meditation participation was tracked by the smartphone app developers and reported to the Principal Investigator. Adherence benchmarks were defined as an average of ≥49 min/week of meditation across all participants (i.e., ≥70% of prescribed meditation).
Measured: Change from Baseline to Week 5 and Week 9
Limited-Efficacy Testing of Meditation
Limited-efficacy testing was measured with Cohen's d effect sizes calculated for patient-reported outcomes (described below as secondary outcomes).
Measured: Change from Baseline to Week 5 and Week 9
Secondary outcomes (8)
MPN Total Symptom Burden (severity and symptomology)
A 10-item, validated form that calculates total symptom burden score (MPN Symptom Assessment Form Total Symptom Score). A higher score indicates a worse MPN-specific symptom burden; scores range from 0-100
Measured: Change from Baseline to Week 5 and Week 9
Fatigue
A single-item fatigue question taken from the MPN Symptom Assessment Form; scores can range from 0-10
Measured: Change from Baseline to Week 5 and Change from Baseline to Week 9
Anxiety
National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Anxiety Short Form; this scale consists of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; scores range from 36.3-82.7
Measured: Change from Baseline to Week 5 and Week 9
Depression
National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Depression Adult Short Form; this scale consists of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; scores range from 41.0-79.4
Measured: Change from Baseline to Week 5 and Week 9
Sleep Disturbance
National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Sleep Disturbance Adult Short Form; this scale consists of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; scores range from 32.0-73.3
Measured: Change from Baseline to Week 5 and Week 9
Sexual Function
National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Sexual Function consisting of five sub-scales; these scales consist of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; the five sub-scales include vaginal discomfort (score range of 33.2-77.08), lubrication (score range of 30.99-69.26), erectile function (score range of 30.72-68.47), satisfaction with sex life (score range of 29.59-72.01), and interest in sexual activity (score range of 32.02-76.17)
Measured: Change from Baseline to Week 5 and Week 9
Pain Intensity
National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Pain Intensity Adult Short Form; this scale consists of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; scores range from 30.7-71.8
Measured: Change from Baseline to Week 5 and Week 9
Global Health
National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS) Global Health consisting of Physical Health and Mental Health sub-scales; these scales consist of a series of questions that are tallied up into a sum score and converted to a standardized t-score. A higher score represents a higher presence, not necessarily a better or worse score, of the item being measured; score ranges for physical health are 16.2-67.7 and score ranges for mental health are 21.1-67.6
Measured: Change from Baseline to Week 5 and Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start31 Jul 2017
- Primary completion2 Apr 2018
- Study completion2 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloproliferative NeoplasmStudies 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
- Crossover
- Model description
- This study was a 4-group randomized trial design in which participants were randomly assigned to 4 unique groups that lasted for 8 weeks in total. Each group received two 4-week conditions involving one of three different conditions/arms.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Huberty, Arizona State University
- Investigators
- Jennifer Huberty, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726944
- Sponsor's protocol ID
- STUDY00006404
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Huberty J, Eckert R, Larkey L, Kurka J, Rodriguez De Jesus SA, Yoo W, Mesa R. Smartphone-Based Meditation for Myeloproliferative Neoplasm Patients: Feasibility Study to Inform Future Trials. JMIR Form Res. 2019 Apr 29;3(2):e12662. doi: 10.2196/12662.
PubMed 31033443
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using a Consumer-based Mobile App to Improve Fatigue and Emotional Symptoms in Myeloproliferative Neoplasm Patients
- ClinicalTrials.gov ID
- NCT03726944
- Acronym / sponsor ID
- STUDY00006404
- Conditions
- Myeloproliferative Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 1 Nov 2018 (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.
This study was a four-group randomized pilot trial in myeloproliferative neoplasm (MPN) patients. Patients were recruited nationally through organizational partners and social media. Eligible and consented patients were enrolled into one of four groups, two of which received varying orders of two consumer-based apps (unnamed consumer-based [CB] app and Calm App) and two that received one of the apps alone for the second four weeks of the eight week intervention after an educational control condition. Participants were asked to perform 10 min/day of smartphone-based meditation irrespective of the app and/or the order in which they received the apps. Feasibility outcomes were measured at week five and nine with an online survey. Feasibility outcomes were acceptability, demand, and limited efficacy for depression, anxiety, pain intensity, sleep disturbance, sexual function, quality of life, global health, and total symptom burden. The purpose of this study was to examine the feasibility of the use of two different consumer-based meditation smartphone applications (i.e., apps) in MPN patients.
Specific aim #1: Examine the feasibility of daily meditation delivered using a consumer-based mobile app. Hypothesis: It will feasible to deliver smartphone-based meditation to MPN patients.
Exploratory Aim: Explore the preliminary effects of daily meditation delivered using a consumer-based mobile app on MPN self-report fatigue, anxiety, depression, pain intensity, sleep disturbance, sexual function, global health, quality of life, and total symptom burden. Hypothesis: There will be demonstrated preliminary effects on patient-reported outcomes in MPN patients.
Detailed description
This was a four-group, randomized controlled trial with a cross-over design. Patients were enrolled into one of four groups with varying order of receiving two consumer-based meditation smartphone (i.e., unnamed consumer-based app [CB app], Calm app) apps in 4-week increments over eight weeks. Group #1 received the CB App followed by the Calm app; Group #2 received the Calm app followed by the CB app; Group #3 received educational control followed by the CB app and Group #4 received educational control followed by the Calm app.
MPN patients were recruited online through MPN organizational partners with a single page, broad overview of the study and its requirements. The study was advertised as a smartphone app meditation study. MPN patients interested in the study were asked to complete an online eligibility questionnaire administered via Qualtrics. Researchers then checked completed eligibility questionnaires as they were completed and emailed patients with their eligibility status.
If ineligible, patients received an email stating their ineligibility status as well as links to both consumer-based apps used in the study in case the ineligible participant was interested in trying meditation. Eligible patients were invited to participate in a 20-minute phone appointment in which the study details and informed consent were described in detail. MPN patients who completed the intake appointment were then sent an informed consent electronically via Qualtrics that included a place for their electronic signature.
Upon receipt of the completed informed consent, participants were randomly assigned to one of four groups. A group assignment list was generated prior to study commencement with randomizer.org. This pre-generated list was then used by research personnel to place eligible, consented MPN patients into their group assignment (i.e., Group #1, Group #2, Group #3, Group #4; described below) in the order in which they consented to participate. Randomized participants were provided with a "welcome email" that contained a) a welcome letter introducing them to the study, b) a calendar detailing important study dates, c) instructions specific to the first assigned condition (i.e., CB app, Calm app, or educational control) to be introduced for the first four weeks. After participants completed the first of their two, four-week conditions (i.e., CB App, Calm, or control), they were provided with another email that included instructions specific to their final condition (i.e., CB app, Calm app, or educational control).
Unnamed Consumer-Based (CB) App The CB app was an already existing consumer-based smartphone app. The first and second week consisted of meditation that was basic introductory, and educational for those new to meditation. Weeks three and four consisted of a new and unique daily meditation that study participants could select from a library of meditations within the app. Each of the daily meditations had a different focus (e.g., grief, gratitude, choice, letting go, etc.) and were ~10-12 minutes in length.
Description of Conditions
Calm App The Calm app was an already-existing, consumer-based meditation app. The first week of the intervention included the "7 Days of Calm", which consists of seven days of introductory meditations that incorporated basic, educational information for those new to meditation while introducing brief experiential practices within that short period of time. Weeks two through four consisted of the "Daily Calm", which is a new and unique daily guided meditation that was provided by the app. Each of the daily meditations had a different focus (e.g., practicing patience, loving-kindness, gratitude, etc.) and were ~10-12 minutes in length.
Educational Control The control condition was provided with educational material handout that was developed by the research team prior to the study. The handout addressed MPN patient fatigue (e.g., What causes fatigue?) as well as examples of and information related to evidence-based fatigue-management strategies.
Description of Groups
Group #1 (CB App + Calm) Group #1 was assigned the CB App (Weeks 1-4) and the Calm app (Weeks 5-8). During weeks 1-4, participants were asked to complete four weeks of meditation on the CB App via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could. During weeks 5-8, participants were asked to complete four weeks of meditation on the Calm app via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could.
Group #2 (Calm APP + CB App) Group #2 was assigned the Calm app (Weeks 1-4) and the CB app (Weeks 5-8). During weeks 1-4, participants were asked to complete four weeks of meditation on the Calm app via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could. During weeks 5-8, participants were asked to complete four weeks of meditation on the CB app via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could.
Group #3 (Control + CB App) Group #3 was assigned educational control (Weeks 1-4) and the CB app (Weeks 5-8). During weeks 1-4, participants were provided the educational material handout and asked to maintain their normal routine. During weeks 5-8, participants were asked to complete four weeks of meditation on the CB app via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could.
Group #4 (Control + Calm) Group #4 was assigned educational control (Weeks 1-4) and the Calm app (Weeks 5-8). During weeks 1-4, participants were provided the educational material handout and asked to maintain their normal routine. During weeks 5-8, participants were asked to complete four weeks of meditation on the Calm app via their smartphone for a minimum of 10 min/day (i.e., ~70 min/week) but encouraged to do more if they could.
All study participants completed patient-reported outcomes measures via an online questionnaire at baseline (week 0), mid-point (week 5), and post-intervention (week 9).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study was a 4-group randomized trial design in which participants were randomly assigned to 4 unique groups that lasted for 8 weeks in total. Each group received two 4-week conditions involving one of three different conditions/arms.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Meditation1+Meditation2 | Other | Behavioral: Calm App Meditation, Behavioral: Unnamed Consumer-Based App Meditation8 weeks in total; 4 weeks of unnamed consumer-based meditation app + 4 weeks of Calm meditation app |
| Group 2 - Meditation2+Meditation1 | Other | Behavioral: Calm App Meditation, Behavioral: Unnamed Consumer-Based App Meditation8 weeks in total; 4 weeks of Calm meditation app + 4 weeks of unnamed consumer-based meditation app |
| Group 3 - Control+Meditation1 | Other | Behavioral: Unnamed Consumer-Based App Meditation, Other: Educational Control8 weeks in total; 4 weeks of educational control + 4 weeks of unnamed consumer-based meditation app |
| Group 4 - Control+Meditation2 | Other | Behavioral: Calm App Meditation, Other: Educational Control8 weeks in total; 4 weeks of educational control + 4 weeks of Calm meditation app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- had a diagnosis of MPN (i.e., essential thrombocythemia, polycythemia vera, or myelofibrosis) identified by treating physician
- owned a mobile smartphone and were willing to download and use a meditation app (i.e., CB or Calm)
- could read and understand English
- were age 18 years or older
- were willing to be randomized to one of four groups: 1) CB 4 wks/Calm 4 wks, 2) Calm 4 wks/CB 4 wks, 3) educational material 4 wks/CB 4 wks, and 4) educational material 4 wks/Calm 4 wks,
Key exclusion criteria (4 listed)
- engaged in ≥10 min/day of meditation on ≥5 days/week for the past 6 months
- engaged in ≥60 min/week of tai chi, qigong, or yoga each week
- utilized either App #1 or Calm
- resided outside of the United States of America
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 App MeditationThe Calm app intervention consisted of 10 min/day of meditation for 4 weeks via the Calm smartphone app. | Behavioural | Group 1 - Meditation1+Meditation2, Group 2 - Meditation2+Meditation1, Group 4 - Control+Meditation2 |
| Unnamed Consumer-Based App MeditationThe unnamed consumer-based app intervention consisted of 10 min/day of meditation for 4 weeks via an unnamed consumer-based meditation smartphone app. | Behavioural | Group 1 - Meditation1+Meditation2, Group 2 - Meditation2+Meditation1, Group 3 - Control+Meditation1 |
| Educational ControlThe educational control consisted of an educational handout that was provided to participants. This control lasted for 4 weeks. | Other | Group 3 - Control+Meditation1, Group 4 - Control+Meditation2 |
Primary outcome
Acceptability of Intervention: survey
Time frame: Change from Baseline to Week 5 and Week 9
Acceptability was measured with a satisfaction survey. Benchmarks for acceptability included ≥70% response to the following questions in the survey: 1) satisfaction with the apps' content, 2) intending to continue using the app, 3) enjoying using the apps, and 4) recommending it for other MPN patients. The % of participants indicating responses to the four prior questions will be considered "acceptable" if all four questions are responded to with a ≥70% response rate.
Demand of Meditation
Time frame: Change from Baseline to Week 5 and Week 9
Demand was measured using adherence to the meditation intervention. Meditation participation was tracked by the smartphone app developers and reported to the Principal Investigator. Adherence benchmarks were defined as an average of ≥49 min/week of meditation across all participants (i.e., ≥70% of prescribed meditation).
Limited-Efficacy Testing of Meditation
Time frame: Change from Baseline to Week 5 and Week 9
Limited-efficacy testing was measured with Cohen's d effect sizes calculated for patient-reported outcomes (described below as secondary outcomes).
8 secondary outcomes
MPN Total Symptom Burden (severity and symptomology)
Time frame: Change from Baseline to Week 5 and Week 9
Fatigue
Time frame: Change from Baseline to Week 5 and Change from Baseline to Week 9
Anxiety
Time frame: Change from Baseline to Week 5 and Week 9
Depression
Time frame: Change from Baseline to Week 5 and Week 9
Sleep Disturbance
Time frame: Change from Baseline to Week 5 and Week 9
Sexual Function
Time frame: Change from Baseline to Week 5 and Week 9
Pain Intensity
Time frame: Change from Baseline to Week 5 and Week 9
Global Health
Time frame: Change from Baseline to Week 5 and Week 9
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 1 Nov 2018.
- Derived from this study: PubMed 31033443Huberty J, Eckert R, Larkey L, Kurka J, Rodriguez De Jesus SA, Yoo W, Mesa R. Smartphone-Based Meditation for Myeloproliferative Neoplasm Patients: Feasibility Study to Inform Future Trials. JMIR Form Res. 2019 Apr 29;3(2):e12662. doi: 10.2196/12662.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
Related trials for Myeloproliferative Neoplasm
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
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.
Jennifer Huberty, PhD principal investigator
Arizona State University
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 App Meditation and Unnamed Consumer-Based App Meditation in people with Myeloproliferative Neoplasm, 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 5 inclusion and 4 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 1 Nov 2018. 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?
Acceptability of Intervention: survey (time frame: Change from Baseline to Week 5 and Week 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03726944, which also lists 1 linked publication.
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 1 Nov 2018.