JMIR Formative Research · 2020 · 17 citations · 23 references
MedicineHealth EducationOncologyCancer ControlMobile Health InformaticsOutcomes ResearchClinical TrialsMobile Health ApplicationsHealth Education ApplicationsMobile App TestingMobile Therapeutic ApplicationsMyeloproliferative Neoplasm TherapyMyeloproliferative Neoplasm Treatment
BACKGROUND: Smartphone ownership is becoming ubiquitous among US adults, making the delivery of health interventions via a mobile app (ie, mobile health [mHealth]) attractive to many researchers and clinicians. Meditation interventions have become popular and have been delivered to study participants via mobile apps to improve a range of health outcomes in both healthy adults and those with chronic diseases. However, these meditation mHealth interventions have been limited by a lack of high-quality control groups. More specifically, these studies have lacked consistency in their use of active, time-matched, and attention-matched control groups. OBJECTIVE: The purpose of this study is to beta test a novel health education podcast control condition delivered via a smartphone app that would be a strong comparator to be used in future studies of app-based meditation interventions. METHODS: Patients with myeloproliferative neoplasm (MPN) cancer were recruited nationally. Upon enrollment, participants were informed to download the investigator-developed health education podcast app onto their mobile phone and listen to ~60 min/week of cancer-related educational podcasts for 12 weeks. The benchmarks for feasibility included ≥70% of participants completing ≥70% of the prescribed 60 min/week of podcasts, ≥70% of participants reporting that they were satisfied with the intervention, and ≥70% of participants reporting that they enjoyed the health education podcasts. RESULTS: A total of 96 patients with MPN were enrolled in the study; however, 19 never began the intervention. Of the 77 patients who participated in the intervention, 39 completed the entire study (ie, sustained participation through the follow-up period). Participation averaged 103.2 (SD 29.5) min/week. For 83.3% (10/12) of the weeks, at least 70% of participants completed at least 70% of their total prescribed use. Almost half of participants reported that they enjoyed the health education podcasts (19/39, 48.7%) and were satisfied with the intervention (17/39, 43.6%). There were no significant changes in cancer-related outcomes from baseline to postintervention. CONCLUSIONS: A 12-week, health education podcast mobile app was demanded but not accepted in a sample of patients with cancer. Using the mobile app was not associated with significant changes in cancer-related symptoms. Based on findings from this study, a health education podcast mobile app may be a feasible option as a time- and attention-matched control group for efficacy trials with more extensive formative research for the content of the podcasts and its acceptability by the specific population. TRIAL REGISTRATION: ClinicalTrials.gov NCT03907774; https://clinicaltrials.gov/ct2/show/NCT03907774.
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How We Design Feasibility Studies
Deborah J. Bowen, Matthew W. Kreuter, Bonnie Spring et al. · American Journal of Preventive Medicine · 2009 · 3.8K citations · Full text
Ron D. Hays, Dennis A. Revicki, Karen L. Spritzer et al. · Quality of Life Research · 2009 · 2K citations · Full text