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MPN Podcast Pilot Study

26. mars 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

39

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85004
        • Arizona State University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

The group will be compiled of eligible participants recruited through physicians, social media, and other online-based recruitment strategies.

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acceptability of Podcast App: satisfaction survey
Tidsramme: 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.
Change from baseline to mid-point (week 6) and post-intervention (week 12)
Demand of Podcast App
Tidsramme: 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).
Change from baseline to mid-point (week 6) and post-intervention (week 12)
Practicality of Podcast App: participation rate
Tidsramme: 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.
Change from baseline to mid-point (week 6) and post-intervention (week 12)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
MPN Total Symptom Burden (severity and symptomology)
Tidsramme: Change from baseline to mid-point (week 6) and post-intervention (week 12)
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.
Change from baseline to mid-point (week 6) and post-intervention (week 12)
Fatigue
Tidsramme: 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.
Change from baseline to mid-point (week 6) and post-intervention (week 12)
Anxiety
Tidsramme: 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) 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.
Change from baseline to mid-point (week 6) and post-intervention (week 12)
Depression
Tidsramme: 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.
Change from baseline to mid-point (week 6) and post-intervention (week 12)
Sleep Disturbance
Tidsramme: 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.
Change from baseline to mid-point (week 6) and post-intervention (week 12)
Sexual Function
Tidsramme: 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).
Change from baseline to mid-point (week 6) and post-intervention (week 12)
Pain Intensity: NIH Promis Pain Intensity Adult Short Form
Tidsramme: 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.
Change from baseline to mid-point (week 6) and post-intervention (week 12)
Global Health
Tidsramme: 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) 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.
Change from baseline to mid-point (week 6) and post-intervention (week 12)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Arizona State University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2019

Primær fullføring (Faktiske)

24. november 2019

Studiet fullført (Faktiske)

24. november 2019

Datoer for studieregistrering

Først innsendt

5. april 2019

Først innsendt som oppfylte QC-kriteriene

8. april 2019

Først lagt ut (Faktiske)

9. april 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. mars 2020

Sist bekreftet

1. mars 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00008403

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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