Discussion
toxicity, TTD
RECRUITMENT, CHRONIC DISEASE
Since MBC is a chronic disease, maintaining a good QoL is of foremost importance. Enrolled patients receive an approved therapy (aromatase inhibitor + palbociclib or fulvestrant + palbociclib) in both arms of this randomized study. Potential risks (e.g., toxicity) should be equally distributed between both arms. A theoretical, albeit unlikely, risk might be that an eHealth-based high density observation using CANKADO could have a negative impact on clinical outcome or QoL. Therefore, the primary objective is to demonstrate superiority of time to deterioration (TTD) of quality of life for patients with eHealth-based high-density observation using CANKADO (CANKADO active) versus eHealth-based static observation on site (CANKADO inform). This clear focus on QoL should provide a benefit for all patients enrolled to this trial.To our knowledge, PreCycle is the largest world-wide trial evaluation of the benefits of an eHealth therapy support in oncology. This trial should lead to an increased awareness of eHealth tools like CANKADO to monitor QoL under systemic treatment. Continuous PRO documentation may lead to increased patient empowerment in oncology and addresses an urgent need as oral therapies are becoming much more frequent [PreCycle started recruitment in mid-2017 and has already recruited almost 500 patients.