Evaluating a digital tool for supporting breast cancer patients: a randomised controlled trial protocol (ADAPT)

Abstract

Background: There is 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. Methods: This randomised 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 NHS health resource utilisation 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 months, 6 months and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilisation 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. Discussion: This 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 tumour 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 registration: The study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019.