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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rozpoznaniem histologicznym nowotworu piersi wrażliwego na hormony (ER i/lub PgR dodatni)
- •Rak piersi w stopniu I-III bez przerzutów odległych i bez wznowy lokalnej
- •Aktualnie leczony hormonalnie (tamoksyfen lub inhibitory aromatazy, z dodatkowymi lekami lub bez)
- •Doświadczający niepożądanych skutków ubocznych leczenia hormonalnego
- •Wiek co najmniej 18 lat
- •Posiadający smartfon
- •Zdolny do czytania i rozumienia instrukcji w języku francuskim
- •Podpisany świadomą zgodę na udział w badaniu
✗ Disqualifies
- •Poważne problemy ze zdolnością myślenia lub zaburzenia psychiatryczne mogące wpłynąć na współpracę w badaniu
- •Pod opieką sądową lub pozbawiony wolności
- •Uczestniczący jednocześnie w innym badaniu behawioralnym
- •Cierpią na inną wyleczalną przyczynę skutków ubocznych leczenia (np. niedokrwistość, zaburzenia elektrolitów, zakażenia, zaburzenia funkcji nerek)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- December 1, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Gustave Roussy
Villejuif, France
Trial contact
Maria Alice FRANZOI, MD
Chloé Serhal, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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