NCT03907774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2019

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

April 5, 2019

Last Update Submit

March 26, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (8)

  • MPN Total Symptom Burden (severity and symptomology)

    Change from baseline to mid-point (week 6) and post-intervention (week 12)

  • Fatigue

    Change from baseline to mid-point (week 6) and post-intervention (week 12)

  • Anxiety

    Change from baseline to mid-point (week 6) and post-intervention (week 12)

  • Depression

    Change from baseline to mid-point (week 6) and post-intervention (week 12)

  • Sleep Disturbance

    Change from baseline to mid-point (week 6) and post-intervention (week 12)

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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
  • years or older

You may not qualify if:

  • Any planned change in pharmacologic intervention (i.e., new drug, bone marrow transplant) during the study interval (i.e., 12 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jennifer Huberty, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 9, 2019

Study Start

June 1, 2019

Primary Completion

November 24, 2019

Study Completion

November 24, 2019

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations