Abstract
BackgroundThere are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management.MethodsThis randomized controlled trial with early stage breast cancer patients will assess the effect of OWise use on patient activation at 3 months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status, and National Health Service (NHS) health resource utilization over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3, 6, and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilization data from Discover, an integrated care record of primary, secondary, and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per-protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results.DiscussionThis study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate, and assess the effects of contamination.Trial registrationThe study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019.
Highlights
There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects
With the incidence of breast cancer expected to increase in the United Kingdom (UK) over the 15 years [1], the National Health Service (NHS) is promoting increased self-management of care [3]
Aim This study aims to understand the impact of OWise on health behaviors, health-related quality of life (HRQoL), and health care utilization in early stage breast cancer patients compared to standard care alone
Summary
There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. We will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management. MHealth is the application of mobile technology by patients or health care providers to monitor health and improve outcomes [5]. A recent review has found 12 studies assessing mHealth tools to support self-management in breast cancer patients [6]. Many of the studies assessing mHealth tools found promising results with a wound monitoring application reducing health resource utilization [7], an electronic daily journal stabilizing daily functional activity [8] and an application providing information and support improving selfefficacy and quality of life and reducing symptom interference [9]. The inconsistency in effects highlights the need to rigorously assess the impact of mHealth tools before encouraging use
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