Actively Recruiting
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
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-12-01
180
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
R
Resilience
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed hormone receptor-positive (ER and/or PgR) invasive breast cancer
- Stage I to III breast cancer with no distant metastases or local recurrence
- Currently receiving adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) with or without targeted agents
- Reporting side effects related to ongoing endocrine therapy
- Age 18 years or older
- ECOG Performance Status of 0, 1, or 2
- Possess a smartphone
- Able to understand, sign, and date informed consent
- Willing and able to comply with study visits and procedures
- Affiliated with a social security system
- Able to read and understand French
- Male patients are eligible
- Patients with prior breast cancer or ductal carcinoma in situ (DCIS) are eligible
- Biologic therapy, targeted therapy, and bisphosphonates are allowed during participation
- Pharmacological or non-pharmacological treatments for endocrine therapy adverse effects are allowed at physician discretion
- Patients may have breast reconstruction during the trial
You will not qualify if you...
- Severe cognitive impairments or severe psychiatric disorders that may affect compliance
- Under guardianship or deprived of liberty, or unable to give consent
- Participation in another behavioral interventional trial at enrollment
- Physical reversible and treatable causes of endocrine therapy-related adverse events (e.g., anemia, electrolyte imbalance, infections, renal dysfunction, active metastases, hormonal imbalances such as hypothyroidism or adrenal insufficiency) as judged by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
M
Maria Alice FRANZOI, MD
CONTACT
C
Chloé Serhal, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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