Abstract
METHODS
Women with early-stage breast cancer were randomly assigned (1:1) to standard care (control) or standard care plus the breast cancer digital tool (intervention). Data were collected using a demographic questionnaire, the European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire BR45 (EORTC QLQ-BR45) for breast cancer-specific HRQoL, and the Hospital Anxiety and Depression Scale (HADS) for psychological distress at baseline, 6 weeks, 3 months, 6 months, and 1 year from diagnosis. Linear mixed effect model regression was used to assess the effect of the digital tool over time while correcting for intra-participant correlation.
CONCLUSION
The breast cancer digital tool did not have a significant effect on breast cancer-specific HRQoL and psychological distress over time. The results are consistent with the findings of the primary ADAPT paper, which demonstrated that the digital tool did not have a significant effect on patient activation, HRQoL, and health status. There is a need for personalized support and strategies to enhance digital tool adherence, offering more customized self-management approaches for people affected by breast cancer in the future.
RESULTS
There were no significant differences (p > 0.05) in the EORTC QLQ-BR45 scales and items and HADS scores between participants in the intervention and control groups when adjusted for the primary tumor stage.
TRIAL REGISTRATION
The study was registered at https://clinicaltrials.gov (NCT03866655) on 7 March 2019 ( https://clinicaltrials.gov/study/NCT03866655 ). The full protocol is accessible through the following link: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3971-6 .
PURPOSE
This report presents the secondary outcomes of the ADAPT trial, focusing on the impact of a digital tool designed to support people affected by breast cancer, on breast cancer-specific health-related quality of life (HRQoL) and psychological distress over the first year from diagnosis.