Myeloproliferative Neoplasm, UnclassifiableNCT03907774
MPN Podcast Pilot Study
An observational study of Myeloproliferative Neoplasm, Unclassifiable, run by Arizona State University at 1 site in United States.
Trial summary
Enrolled MPN patients will participate in a podcast intervention via a smartphone app. They will listen to 60 minutes per week of podcasts through this app, which consist of cancer-related health education material. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm, Unclassifiable
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 24 Nov 2019
- Phase
- Observational
- 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
Study population: The group will be compiled of eligible participants recruited through physicians, social media, and other online-based recruitment strategies.
Who may be able to join
- Have a diagnosis of essential thrombocythemia, polycythemia vera, or myelofibrosis identified by treating physician
- Have access to a smartphone on a regular basis
- Have access to reliable home internet
- Read and understand English
- 18 years or older
Who cannot join
- Any planned change in pharmacologic intervention (i.e., new drug, bone marrow transplant) during the study interval (i.e., 12 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of 12 Weeks of Smartphone-based Health Education Podcasts in Myeloproliferative Neoplasm Patients
Enrolled MPN patients will participate in a podcast intervention via a smartphone app. They will listen to 60 minutes per week of podcasts through this app, which consist of cancer-related health education material. Participants have the option to listen to additional podcasts beyond the 60-minute weekly prescription if they desire. Participation will be tracked through self-report logs. In addition, questionnaires will be administered at baseline, midpoint (week 6), and post-intervention (week 12), which ask about demographics, health information, and satisfaction. The hypothesis is that the smartphone app is feasible for delivering home-based health education podcasts to MPN patients.
Read the detailed description
Interested patients will complete an eligibility screening using a REDCap link (see eligibility survey). The eligibility screening takes 5-10 minutes to complete.
If ineligible, the participant will be sent an email notification (see study protocol).
If eligible, the potential participant will be sent a link to a video containing a detailed overview of the informed consent as well as a link to sign the informed consent. There will be a place for the participant to type in their electronic signature, which will constitute their consent to participate in the study (see informed consent). After signing the informed consent, participants will be sent an additional email with their study start date, which will fall on the next Monday after signing the informed consent so that all participants begin participating on a Monday. On the day of their study start date, participants will be sent a welcome email as well as a link to complete the baseline self-report measure (listed below) via REDCap.
Within the welcome email, there will be step-by-step instructions for accessing the podcast intervention via a smartphone app. Participants will be asked to view 60 minutes per week of podcasts through a smartphone app. The podcast videos will contain general cancer-related health education material. A total of 60 minutes per week will be prescribed, however, participants will have the ability to view additional videos each week. Furthermore, participants will also track their podcast video viewing each week in a weekly log (see weekly log) by recording each time they view a video, the video that they viewed, and how long they viewed the video.
The investigators will use self-report questionnaires at baseline (week 0), mid-point (week 6), and post-intervention (week 12) administered via REDCap (see baseline, mid-point, and post-intervention surveys). Demographics data and MPN-related health information will be collected at baseline and satisfaction-related data will be collected within the post-intervention questionnaire. Feasibility measures will include acceptability, demand, and practicality.
- Medical subject headings
- Myeloproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Podcast App: satisfaction survey
Acceptability will be measured with a satisfaction survey. Benchmarks for acceptability include greater than or equal to 70% response to the following questions in the survey: 1) satisfaction with the app's content, 2) intending to continue using the app, 3) enjoying using the apps, and 4) recommending it to 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 greater than or equal to 70% response rate.
Measured: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Demand of Podcast App
Demand will be measured using adherence to the podcast prescription. Podcast viewing will be tracked by the smartphone app developers and reported to the Principal Investigator. Adherence benchmarks are defined as an average of greater than or equal to 49 minutes per week of podcast viewing across all participants (i.e., greater than or equal to 70% of prescribed podcasts).
Measured: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Practicality of Podcast App: participation rate
Practicality will be measured through a participation rate greater than or equal to 70%, with completion being defined as completing all three self-report questionnaires.
Measured: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Secondary outcomes (8)
MPN Total Symptom Burden (severity and symptomology)
A 10-item, validated form that calculates total symptom burden score through the 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 mid-point (week 6) and post-intervention (week 12)
Fatigue
A single-item fatigue question taken from the MPN Symptom Assessment Form; scores can range from 0-10.
Measured: Change from baseline to mid-point (week 6) and post-intervention (week 12)
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 mid-point (week 6) and post-intervention (week 12)
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 mid-point (week 6) and post-intervention (week 12)
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 mid-point (week 6) and post-intervention (week 12)
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 dysfunction (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 mid-point (week 6) and post-intervention (week 12)
Pain Intensity: NIH Promis Pain Intensity Adult Short Form
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 mid-point (week 6) and post-intervention (week 12)
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; scores 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 mid-point (week 6) and post-intervention (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Jun 2019
- Primary completion24 Nov 2019
- Study completion24 Nov 2019
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 Neoplasm, UnclassifiableStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Huberty, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907774
- Sponsor's protocol ID
- STUDY00008403
- Status last verified
- Mar 2020
- First submitted
- 5 Apr 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huberty J, Eckert R, Puzia M, Laird B, Larkey L, Mesa R. A Novel Educational Control Group Mobile App for Meditation Interventions: Single-Group Feasibility Trial. JMIR Form Res. 2020 Jul 21;4(7):e19364. doi: 10.2196/19364.
PubMed 32706719
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of 12 Weeks of Smartphone-based Health Education Podcasts in Myeloproliferative Neoplasm Patients
- ClinicalTrials.gov ID
- NCT03907774
- Acronym / sponsor ID
- STUDY00008403
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 24 Nov 2019 (actual)
- Study completion
- 24 Nov 2019 (actual)
- First posted
- 9 Apr 2019 (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.
Enrolled MPN patients will participate in a podcast intervention via a smartphone app. They will listen to 60 minutes per week of podcasts through this app, which consist of cancer-related health education material. Participants have the option to listen to additional podcasts beyond the 60-minute weekly prescription if they desire. Participation will be tracked through self-report logs. In addition, questionnaires will be administered at baseline, midpoint (week 6), and post-intervention (week 12), which ask about demographics, health information, and satisfaction. The hypothesis is that the smartphone app is feasible for delivering home-based health education podcasts to MPN patients.
Detailed description
Interested patients will complete an eligibility screening using a REDCap link (see eligibility survey). The eligibility screening takes 5-10 minutes to complete.
If ineligible, the participant will be sent an email notification (see study protocol).
If eligible, the potential participant will be sent a link to a video containing a detailed overview of the informed consent as well as a link to sign the informed consent. There will be a place for the participant to type in their electronic signature, which will constitute their consent to participate in the study (see informed consent). After signing the informed consent, participants will be sent an additional email with their study start date, which will fall on the next Monday after signing the informed consent so that all participants begin participating on a Monday. On the day of their study start date, participants will be sent a welcome email as well as a link to complete the baseline self-report measure (listed below) via REDCap.
Within the welcome email, there will be step-by-step instructions for accessing the podcast intervention via a smartphone app. Participants will be asked to view 60 minutes per week of podcasts through a smartphone app. The podcast videos will contain general cancer-related health education material. A total of 60 minutes per week will be prescribed, however, participants will have the ability to view additional videos each week. Furthermore, participants will also track their podcast video viewing each week in a weekly log (see weekly log) by recording each time they view a video, the video that they viewed, and how long they viewed the video.
The investigators will use self-report questionnaires at baseline (week 0), mid-point (week 6), and post-intervention (week 12) administered via REDCap (see baseline, mid-point, and post-intervention surveys). Demographics data and MPN-related health information will be collected at baseline and satisfaction-related data will be collected within the post-intervention questionnaire. Feasibility measures will include acceptability, demand, and practicality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The group will be compiled of eligible participants recruited through physicians, social media, and other online-based recruitment strategies.
Key inclusion criteria (5 listed)
- Have a diagnosis of essential thrombocythemia, polycythemia vera, or myelofibrosis identified by treating physician
- Have access to a smartphone on a regular basis
- Have access to reliable home internet
- Read and understand English
- 18 years or older
Key exclusion criteria (1 listed)
- Any planned change in pharmacologic intervention (i.e., new drug, bone marrow transplant) during the study interval (i.e., 12 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptability of Podcast App: satisfaction survey
Time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Acceptability will be measured with a satisfaction survey. Benchmarks for acceptability include greater than or equal to 70% response to the following questions in the survey: 1) satisfaction with the app's content, 2) intending to continue using the app, 3) enjoying using the apps, and 4) recommending it to 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 greater than or equal to 70% response rate.
Demand of Podcast App
Time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Demand will be measured using adherence to the podcast prescription. Podcast viewing will be tracked by the smartphone app developers and reported to the Principal Investigator. Adherence benchmarks are defined as an average of greater than or equal to 49 minutes per week of podcast viewing across all participants (i.e., greater than or equal to 70% of prescribed podcasts).
Practicality of Podcast App: participation rate
Time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Practicality will be measured through a participation rate greater than or equal to 70%, with completion being defined as completing all three self-report questionnaires.
8 secondary outcomes
MPN Total Symptom Burden (severity and symptomology)
Time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Fatigue
Time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Anxiety
Time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Depression
Time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Sleep Disturbance
Time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Sexual Function
Time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Pain Intensity: NIH Promis Pain Intensity Adult Short Form
Time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Global Health
Time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
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 27 Mar 2020.
- Derived from this study: PubMed 32706719Huberty J, Eckert R, Puzia M, Laird B, Larkey L, Mesa R. A Novel Educational Control Group Mobile App for Meditation Interventions: Single-Group Feasibility Trial. JMIR Form Res. 2020 Jul 21;4(7):e19364. doi: 10.2196/19364.
- 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.
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?
An observational study of Myeloproliferative Neoplasm, Unclassifiable, 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 1 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 27 Mar 2020. 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 Podcast App: satisfaction survey (time frame: Change from baseline to mid-point (week 6) and post-intervention (week 12)). 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 NCT03907774, 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 27 Mar 2020.