Digital self-management support to improve quality of life during adjuvant hormonal therapy

Phase III Randomized Controlled Open Label Clinical Trial 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 trial tests whether a personalized mobile app plus usual care can help people with early hormone receptor–positive breast cancer have fewer endocrine therapy side effects and better quality of life.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Academic / other)
• Locations: 1 site (Villejuif)
• Trial ID: NCT06781996 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, open-label trial in France will enroll 180 patients with stage I–III hormone receptor–positive breast cancer who are currently on adjuvant endocrine therapy and reporting related side effects. Participants are randomized 1:1 to 12 weeks of the multimodal Resilience© digital companion delivered via a mobile app plus standard supportive care or to standard supportive care alone. The app provides personalized education, self-care modules, and collects patient-reported outcomes to track symptoms and well-being. The study compares quality of life and symptom burden between groups over the 12-week intervention period.

Who should consider this trial

Good fit: Ideal candidates are adults in France with stage I–III hormone receptor–positive breast cancer who are actively receiving adjuvant endocrine therapy and report endocrine therapy–related adverse effects.

Not a fit: Patients with distant metastatic or locally recurrent disease, those not taking endocrine therapy, or people without a compatible smartphone or reliable internet access are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the app could reduce endocrine therapy side effects, improve quality of life, and support patients to remain on their prescribed hormonal treatment.

How similar studies have performed: Previous smaller studies and patient-reported outcome–based oncology interventions have shown promise for digital symptom-support tools, but robust phase 3 evidence is still limited.

Eligibility criteria

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.

Where this trial is running

Villejuif

• Gustave Roussy — Villejuif, France (Recruiting)

Study contacts

• Study coordinator: Maria Alice FRANZOI, MD

Conditions Breast Cancer; Breast Cancer Early Stage Breast Cancer; early stage breast cancer; Hormone-receptor positive; endocrine therapy-related adverse events