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

Russell, Lahiru, Pascoe, Michaela C, Seymour, John F, Aranda, Sanchia, Butow, Phyllis, Gough, Karla and Schofield, Penelope 2019, 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, BMC research notes, vol. 12, pp. 1-5, doi: 10.1186/s13104-019-4264-6.

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Title 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
Author(s) Russell, LahiruORCID iD for Russell, Lahiru orcid.org/0000-0002-3806-0020
Pascoe, Michaela C
Seymour, John F
Aranda, Sanchia
Butow, Phyllis
Gough, Karla
Schofield, Penelope
Journal name BMC research notes
Volume number 12
Article ID 226
Start page 1
End page 5
Total pages 5
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2019
ISSN 1756-0500
Keyword(s) m-health
Feasibility
Chronic myeloid leukemia
Supportive care trials
Summary 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.
Language eng
DOI 10.1186/s13104-019-4264-6
Indigenous content off
Field of Research 1199 Other Medical and Health Sciences
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2019, The Author(s)
Persistent URL http://hdl.handle.net/10536/DRO/DU:30128401

Document type: Journal Article
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School of Nursing and Midwifery
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