Clinical trial NCT03907774: MPN Podcast Pilot Study
Official title: A Feasibility Study of 12 Weeks of Smartphone-based Health Education Podcasts in Myeloproliferative Neoplasm Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myeloproliferative Neoplasm, Unclassifiable
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The group will be compiled of eligible participants recruited through physicians, social media, and other online-based recruitment strategies.

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Acceptability of Podcast App: satisfaction survey
timeFrame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
measure: Demand of Podcast App
timeFrame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
measure: Practicality of Podcast App: participation rate
timeFrame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Secondary outcomes:
measure: MPN Total Symptom Burden (severity and symptomology)
timeFrame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
measure: Fatigue
timeFrame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
measure: Anxiety
timeFrame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
measure: Depression
timeFrame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
measure: Sleep Disturbance
timeFrame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
measure: Sexual Function
timeFrame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
measure: Pain Intensity: NIH Promis Pain Intensity Adult Short Form
timeFrame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
measure: Global Health
timeFrame: Change from baseline to mid-point (week 6) and post-intervention (week 12)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Jennifer Huberty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.