MPN Podcast Pilot Study
26 maart 2020 bijgewerkt door: Arizona State University
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.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
39
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85004
- Arizona State University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
The group will be compiled of eligible participants recruited through physicians, social media, and other online-based recruitment strategies.
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any planned change in pharmacologic intervention (i.e., new drug, bone marrow transplant) during the study interval (i.e., 12 weeks)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Acceptability of Podcast App: satisfaction survey
Tijdsspanne: Change from baseline to mid-point (week 6) and post-intervention (week 12)
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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.
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Change from baseline to mid-point (week 6) and post-intervention (week 12)
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Demand of Podcast App
Tijdsspanne: Change from baseline to mid-point (week 6) and post-intervention (week 12)
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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).
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Change from baseline to mid-point (week 6) and post-intervention (week 12)
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Practicality of Podcast App: participation rate
Tijdsspanne: Change from baseline to mid-point (week 6) and post-intervention (week 12)
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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.
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Change from baseline to mid-point (week 6) and post-intervention (week 12)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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MPN Total Symptom Burden (severity and symptomology)
Tijdsspanne: Change from baseline to mid-point (week 6) and post-intervention (week 12)
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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.
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Change from baseline to mid-point (week 6) and post-intervention (week 12)
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Fatigue
Tijdsspanne: Change from baseline to mid-point (week 6) and post-intervention (week 12)
|
A single-item fatigue question taken from the MPN Symptom Assessment Form; scores can range from 0-10.
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Change from baseline to mid-point (week 6) and post-intervention (week 12)
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Anxiety
Tijdsspanne: Change from baseline to mid-point (week 6) and post-intervention (week 12)
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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.
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Change from baseline to mid-point (week 6) and post-intervention (week 12)
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Depression
Tijdsspanne: Change from baseline to mid-point (week 6) and post-intervention (week 12)
|
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.
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Change from baseline to mid-point (week 6) and post-intervention (week 12)
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Sleep Disturbance
Tijdsspanne: Change from baseline to mid-point (week 6) and post-intervention (week 12)
|
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.
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Change from baseline to mid-point (week 6) and post-intervention (week 12)
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Sexual Function
Tijdsspanne: Change from baseline to mid-point (week 6) and post-intervention (week 12)
|
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).
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Change from baseline to mid-point (week 6) and post-intervention (week 12)
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Pain Intensity: NIH Promis Pain Intensity Adult Short Form
Tijdsspanne: Change from baseline to mid-point (week 6) and post-intervention (week 12)
|
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.
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Change from baseline to mid-point (week 6) and post-intervention (week 12)
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Global Health
Tijdsspanne: Change from baseline to mid-point (week 6) and post-intervention (week 12)
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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.
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Change from baseline to mid-point (week 6) and post-intervention (week 12)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juni 2019
Primaire voltooiing (Werkelijk)
24 november 2019
Studie voltooiing (Werkelijk)
24 november 2019
Studieregistratiedata
Eerst ingediend
5 april 2019
Eerst ingediend dat voldeed aan de QC-criteria
8 april 2019
Eerst geplaatst (Werkelijk)
9 april 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 maart 2020
Laatste update ingediend die voldeed aan QC-criteria
26 maart 2020
Laatst geverifieerd
1 maart 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY00008403
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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