The breast cancer digital tool had no statistically significant impact on patient activation, HRQoL, and health status over time compared to standard care alone in women with early-stage breast cancer. Future research should focus on identifying and addressing barriers to digital tool engagement to improve efficacy. Clinical trial information The study was registered at https://clinicaltrials.gov (NCT03866655) on 7 March 2019 ( https://clinicaltrials.gov/study/NCT03866655 ).
A total of 166 participants were included, with 85 being randomized into the intervention. No significant differences (p > 0.05) in the PAM-13 scores, EORTC QLQ-C30 scales (global QoL, physical functioning, emotional functioning, pain, fatigue), and EQ-5D-5L Index between the control and intervention groups were observed. It is important to note that there was significant non-adherence within the intervention group.
This study reports the findings from the ADAPT randomized controlled trial (RCT), concerning the impact of a digital tool for supported self-management in people affected by breast cancer on patient activation as the primary outcome, with health-related quality of life (HRQoL), and health status as secondary outcomes.
Women with early-stage breast cancer were randomly assigned to standard care (control) or standard care in addition to the breast cancer digital tool (intervention). Data were collected using a demographic questionnaire, the Patient Activation Measure (PAM-13), the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), and the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) 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 the first year from diagnosis while correcting for intra-participant correlation.
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