Actively Recruiting
Phase III Randomized Controlled Trial of a Digital Self-management Support Tool to Improve 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
39 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
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.
CONDITIONS
Brief 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 metastasis or local recurrence
- Indicated for adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) with or without targeted agents
- Currently receiving endocrine therapy for breast cancer
- Reporting adverse effects related to ongoing endocrine therapy
- Age 18 years or older
- ECOG Performance Status 0, 1, or 2
- Possess a smartphone
- Able to understand, sign, and date informed consent
- Willing and able to comply with study procedures
- Affiliated with a social security system or beneficiary
- Able to read and understand French
- Male patients are eligible
- Patients with previous breast cancer or DCIS are eligible
- Biologic, targeted therapies, and bisphosphonates allowed during participation
- Patients may have breast reconstruction during the study
You will not qualify if you...
- Severe cognitive impairment or severe psychiatric disorders that may affect study compliance
- Under guardianship or deprived of liberty, incapable of giving consent
- Currently participating in another behavioral interventional trial
- Physical causes of endocrine therapy side effects that are reversible and treatable (e.g., anemia, infections, hormonal imbalances) according to physician judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 3 weeks
Participants receive either the standard supportive care alone or standard supportive care plus access to a digital self-management support tool called Resilience© to help manage symptoms during adjuvant hormonal therapy.
1 baseline visit and weekly remote assessments during the 3-week intervention
Duration - Up to 12 months
Participants are monitored for quality of life, symptom management, physical activity, and adherence to therapy up to 12 months after starting the intervention.
Monthly remote follow-up visits up to 12 months
Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
M
Maria Alice FRANZOI, MD
C
Chloé Serhal, PhD
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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