MPN Podcast Pilot Study

Myeloproliferative Neoplasm, Unclassifiable Clinical Trial

Official title:

A Feasibility Study of 12 Weeks of Smartphone-based Health Education Podcasts in Myeloproliferative Neoplasm Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907774
• Other study ID #: STUDY00008403
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: November 24, 2019

Study information

• Verified date: March 2020
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 24, 2019
• Est. primary completion date: November 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasm, Unclassifiable
• Neoplasms

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to mid-point (week 6) and post-intervention (week 12)
Primary	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).	Change from baseline to mid-point (week 6) and post-intervention (week 12)
Primary	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.	Change from baseline to mid-point (week 6) and post-intervention (week 12)
Secondary	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.	Change from baseline to mid-point (week 6) and post-intervention (week 12)
Secondary	Fatigue	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)
Secondary	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.	Change from baseline to mid-point (week 6) and post-intervention (week 12)
Secondary	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.	Change from baseline to mid-point (week 6) and post-intervention (week 12)
Secondary	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.	Change from baseline to mid-point (week 6) and post-intervention (week 12)
Secondary	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).	Change from baseline to mid-point (week 6) and post-intervention (week 12)
Secondary	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.	Change from baseline to mid-point (week 6) and post-intervention (week 12)
Secondary	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.	Change from baseline to mid-point (week 6) and post-intervention (week 12)