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Can a smartphone app ease the burden of breast cancer hormone therapy?

NCT ID NCT06781996

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Gustave Roussy

    RECRUITING

    Villejuif, France

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