Phase 3 Study of a Digital Self-Management App to Improve Quality of Life During Adjuvant Hormonal Therapy for Early Breast Cancer Patients

What this Trial Is About

Researchers are evaluating a personalized digital support program delivered through a mobile app alongside standard care compared to standard care alone for patients with hormone receptor-positive HR early breast cancer who experience side effects from endocrine therapy. This Phase III, open-label, randomized trial conducted in France aims to improve quality of life during adjuvant hormonal treatment. The study involves 180 patients randomly assigned to either the digital support plus standard care group or the standard care-only group. Participants in one group will use the Resilience digital companion, a multi-component mobile application offering educational information, self-symptom management tools, and remote healthcare provider evaluations tailored to patient needs. Both groups will continue receiving standard supportive care from their oncologists and care teams at local cancer centers, which may include referrals to supportive care programs and remote patient monitoring. The intervention period lasts 12 weeks. Throughout the trial, participants will complete assessments to measure quality of life, fatigue, emotional distress, pain, sleep quality, adherence to endocrine therapy, self-efficacy in symptom management, eHealth literacy, and physical activity, some measured by wearable devices. Data collection includes patient-reported outcomes via a web platform. Follow-up and evaluation extend up to 12 months after randomization, with ongoing monitoring of patient experience and intervention adoption.

A Study to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuvant HOrmonal Therapy for Patients With Early Breast Cancer