MPN Podcast Pilot Study
26 de março de 2020 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Real)
39
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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Arizona
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Phoenix, Arizona, Estados Unidos, 85004
- Arizona State University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
The group will be compiled of eligible participants recruited through physicians, social media, and other online-based recruitment strategies.
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Acceptability of Podcast App: satisfaction survey
Prazo: 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)
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Demand of Podcast App
Prazo: 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)
|
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Practicality of Podcast App: participation rate
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
MPN Total Symptom Burden (severity and symptomology)
Prazo: 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
Prazo: 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
Prazo: 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)
|
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Depression
Prazo: 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
Prazo: 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
Prazo: 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)
|
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Pain Intensity: NIH Promis Pain Intensity Adult Short Form
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2019
Conclusão Primária (Real)
24 de novembro de 2019
Conclusão do estudo (Real)
24 de novembro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
5 de abril de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de abril de 2019
Primeira postagem (Real)
9 de abril de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de março de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de março de 2020
Última verificação
1 de março de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00008403
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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