The trials and tribulations of conducting an m-health pilot randomized controlled trial to improve oral cancer therapy adherence: recommendations for future multisite, non-drug clinical trials.

Authors:
Lahiru Russell
Lahiru Russell
Department of Cancer Experiences Research
Michaela C Pascoe
Michaela C Pascoe
Swinburne University
Australia
John F Seymour
John F Seymour
Derriford Hospital
United Kingdom
Sanchia Aranda
Sanchia Aranda
The University of Melbourne
Australia
Phyllis Butow
Phyllis Butow
School of Psychology
Chicago | United States
Karla Gough
Karla Gough
The University of Melbourne
Australia
Penelope Schofield
Penelope Schofield
University of Sydney
Australia

BMC Res Notes 2019 Apr 15;12(1):226. Epub 2019 Apr 15.

Peter MacCallum Cancer Centre, Parkville, Melbourne, VIC, Australia.

Objective: Integrating mobile phone-based health (m-health) interventions into healthcare systems is one solution to improve access to services for the growing number of patients with chronic illness. Practical challenges such as poor recruitment and inadequate resource allocation can hamper the assessment of such interventions with clinical trial methodology. This paper highlights the challenges encountered during a pilot randomized controlled trial of an m-health medication adherence intervention and offers recommendations for future multi-site, non-drug clinical trials.

Results: Eighteen patients were recruited to the study; eight were randomly allocated to the intervention arm. Intervention participants responded to their daily medication-reminder text messages, indicating that medication had been taken or not, and nurses were able to organize their calls around their workload. The trial closed prematurely primarily due to inadequate numbers of eligible patients; however, other potentially resolvable feasibility issues were identified. These included lack of infrastructure at study sites, poor screening data acquisition and management processes, and inexperience in conducting supportive care trials at participating sites. M-health intervention trials are designed to inform implementation of best supportive care practice. Adequate skills and infrastructure are research prerequisites that require careful consideration and sufficient investment for the successful execution of multi-site supportive care trials. Trial registration Australian and New Zealand Clinical Trials Register: ACTRN12612000635864.

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http://dx.doi.org/10.1186/s13104-019-4264-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6466650PMC
April 2019
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