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.
Subjects must have histologically confirmed ER and/or PgR positive HR+ invasive BC;
Subjects must have stage I to III breast cancer and no evidence of distant metastatic or locally recurrent disease;
Indication to receive adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) with or without targeted agents (e.g., CDK 4/6 inhibitors, PARP inhibitors, bisphosphonates);
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;
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;
Patient under guardianship or deprived of her/his liberty by a judicial or administrative decision or incapable of giving her/his consent;
Patients participating at enrollment in a behavioral interventional trial;
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.
Parallel
multimodal Resilience© digital companion
Other interventionResilience© 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
Other interventionstandard 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.
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.
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.
To evaluate the impact of the intervention on other EORTC QLQ-C30 domains, including fatigue, emotional distress, pain, and sleep quality;
To evaluate the impact of the intervention on insomnia measured by a wearable device;
Insomnia by a wearable device capturing sleep quality and sleep cycle (Withings© Pulse HR smartwatch);
To evaluate the impact of the intervention on adherence to endocrine therapy, assessed through the modified MIS-A questionnaire
reliable, easy-to-use, self-administered questionnaire, validated in France that is able to longitudinally capture granular data on non-adherence to chronic medication over short and long time.
To evaluate the impact of the intervention on the perceived self-efficacy of symptom management;
Perceived self-efficacy in symptom management will be evaluated using the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a questionnaire.
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Gustave Roussy, Cancer Campus, Grand Paris
Lead sponsor
Resilience
Collaborator
WeShare
Collaborator
National Cancer Institute, France
Collaborator
