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

Randomized trial that compares a personalized digitally-enabled pathway delivered by a mobile application in addition to standard of care vs. standard of care alone in patients with HR+ early breast cancer reporting endocrine therapy related adverse events. The HOPE study is a national, prospective, randomized, open-label trial conducted in France. 180 patients will be randomly assigned 1:1 to receive either 12 weeks of multimodal Resilience© digital companion including education and self-care modules in addition to the standard of care provided by their treating oncologists and supportive care team at their care centers or 12 weeks of standard of care provided by their treating oncologists and supportive care team at their care centers. Data from the literature in oncology trials with Patient-Reported Outcomes suggests that in the absence of double-blind concealment, clinically important differences could still be detected.

NCT Number	NCT06781996
Lead Sponsor	Gustave Roussy, Cancer Campus, Grand Paris Collaborators: Resilience, WeShare, National Cancer Institute, France
Conditions	Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Enrollment	180 participants
Start Date	2025-09-09
Primary Completion	2026-03-15 (estimated)
Study Completion	2026-12-15 (estimated)
Updated on ClinicalTrials.gov	2025-12-01