Can a smartphone app ease the burden of breast cancer hormone therapy?
NCT ID NCT06781996
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a mobile app called Resilience© can improve quality of life for early-stage breast cancer patients undergoing hormone therapy. The app provides education, symptom management tips, and personalized support. 180 participants in France will be randomly assigned to use the app plus standard care, or standard care alone, for 12 weeks. The goal is to see if the app helps reduce side effects and improve well-being.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mobile app (Resilience© digital companion)
- What this could lead to
- If it works, this could give doctors a simple, scalable way to help breast cancer patients feel better during hormone therapy.
- What could go wrong
- This is a relatively small trial (180 people) testing a digital tool, not a drug. The effect on quality of life may be modest, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Documentation of Disease: 1. Subjects must have histologically confirmed ER and/or PgR positive HR+ invasive BC; 2. Subjects must have stage I to III breast cancer and no evidence of distant metastatic or locally recurrent disease; NB: Bilateral breast carcinoma is allowed; NB: Patients with personal history of previous breast cancer or Ductal Carcinoma in situ (DCIS) are eligible for the protocol; 2. Indication to receive adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) with or without targeted agents (e.g., CDK 4/6 inhibitors, PARP inhibitors, bisphosphonates); 3. Prior treatment: Patients must be actively on ET for their breast cancer diagnosis (any type, including either tamoxifen or an aromatase-inhibitor with or without targeted agents) at the time of study enrollment; 4. Documentation of side effects of ongoing ET: Any endocrine therapy related adverse effects should be reported during treatment with endocrine therapy; 5. Others: 1. Age ≥ 18 years; 2. ECOG Performance Status 0,1 or 2; 3. Patients should possess a smartphone; 4. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed; 5. Patient should be able and willing to comply with study visits and procedures as per protocol; 6. Patients must be affiliated to a social security system or beneficiary of the same; 7. Able to readily read and understand French; NB: Patients may have breast reconstruction during protocol participation; NB: Biologic therapy, targeted therapy and bisphosphonates are acceptable during protocol participation; NB: Male patients can be included in the trial; NB: Pharmacological or other non-pharmacological interventions for endocrine treatment for adverse effects are accepted at physician discretion. Exclusion Criteria: 1. Severe cognitive impairments or severe psychiatric disorders (assessed by the investigator or mentioned in the medical file of the patient) which in the investigator's opinion would jeopardize compliance with the protocol; 2. Patient under guardianship or deprived of her/his liberty by a judicial or administrative decision or incapable of giving her/his consent; 3. Patients participating at enrollment in a behavioral interventional trial; 4. Patients suffering from physical related reversible and treatable causes of the entry endocrine therapy-related adverse events (e.g. but not limited to anemia, electrolytes unbalance, infections, renal dysfunction, active metastases hormonal unbalances \[hypothyroidism, adrenal insufficiency, etc.\] - according to physician's judgement.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gustave Roussy
RECRUITINGVillejuif, France
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