Ireland
--:--IST
Recruiting Phase 3

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

NCT06781996 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-09-09
Last updated
2025-12-01

Condition(s) studied

Breast CancerBreast Cancer Early Stage Breast Cancer (Stage 1-3)

Investigational drug(s) / intervention(s)

multimodal Resilience© digital companionStandard supportive care

multimodal Resilience© digital companion: Resilience© is a multi-component, multi-level interventional mobile application that will offer: (a) supportive educational care information (b) self-symptom management resources with availability of a remote health-care provider evaluation that addresses patient-specific needs in survivorship care and recommends personalized digital self-management resources at onboarding and if needed in case of low engagement in the mobile app. Intervention duration : 3 weeks

Standard supportive care: standard of care provided by the oncologist and supportive care team at the patient local cancer center including referrals for local supportive care programs. Local supportive care programs may also include the use of already deployed remote patient monitoring and solutions, digital and in person education.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • To determine the efficacy of a personalized approach, consisting of a multi-component, interventional mobile application in addition to standard of care, compared with standard care alone in improving quality of life (QOL) after 12 weeks. — up to 12 weeks of intervention
    The primary endpoint of the study is the ET symptoms scale of the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire (QLQ)-BR45 over a 12-weeks period.

Trial sites (1)

FacilityCityRegionStatus
Gustave Roussy Villejuif France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06781996 on ClinicalTrials.gov ↗ ← All trials in France