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.
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.
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 .