Abstract 272P
Background
OWise Breast Cancer is a digital tool for supported self-management in people affected by breast cancer. This study reports the findings from the ADAPT randomized controlled trial (RCT), concerning the impact of OWise on patient activation (Patient Activation Measure, PAM-13) as the primary outcome, with health-related quality of life (HRQoL, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire, EORTC QLQ-C30), and health status (EuroQol 5-Dimension 5-Level questionnaire, EQ-5D-5L) as secondary outcomes.
Methods
Women with early-stage breast cancer were randomly assigned to standard care (control) or standard care in addition to OWise (intervention). Data were collected using a demographic questionnaire, the PAM-13, the EORTC QLQ-C30, and the EQ-5D-5L at baseline, six weeks, three months, six months, and one year from diagnosis. Linear mixed effect model regression was used to assess the effect of OWise over the first year from diagnosis while correcting for intra-participant correlation.
Results
A total of 166 participants were included, with 85 being randomized into the intervention. No significant differences (p>0.05) in the PAM13 scores, EORTC QLQ-C30 (global QoL, physical functioning, emotional functioning, pain, and fatigue), and EQ-5D-5L index between the control and intervention group were observed over time. It is important to note that there was significant non-adherence to using OWise among the intervention group.
Conclusions
OWise had no statistically significant impact on patient activation, HRQoL, and health status over time compared to standard care alone. Future research should focus on identifying and addressing barriers to digital tool engagement to improve efficacy.
Clinical trial identification
NCT03866655; on 7 March 2019.
Legal entity responsible for the study
The authors.
Funding
Part funding was awarded through Innovate UK in the Competition: Support for SMEs to Evaluate Innovative Medical Technologies [Grant 12462]. Additional funding was provided by Px Healthcare who developed OWise. Innovate UK and Px Healthcare monitored the progress of the study but were not involved in study design, collection, analysis, and interpretation of the data, writing the manuscript or decision to submit the report for publication. We would also like to acknowledge the indirect support of the NIHR Biomedical Research Centre at the Royal Marsden and the Institute of Cancer Research, London.
Disclosure
All authors have declared no conflicts of interest.