A Phase 3 interventional study of multimodal Resilience© digital companion and Standard supportive care in Breast Cancer and Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 3, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 180 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Documentation of 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;
Others:
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:
Patients will receive standard of care provided by the oncologist and supportive care team at the patient local cancer center including referrals for local supportive care programs. In addition, patients will have access to Resilience© 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.
Other: multimodal Resilience© digital companion · Other: Standard supportive care
Patients will receive 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.
Other: Standard supportive care
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 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.
Time frame: up to 12 weeks of intervention
To evaluate the impact of the intervention on other EORTC QLQ-C30 domains, including fatigue, emotional distress, pain, and sleep quality;
Time frame: after 12 months of randomization
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);
Time frame: up to 12 months after randomization
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.
Time frame: up to 12 months after randomization
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.
Time frame: up to 12 months after randomization
To evaluate the impact of the intervention on eHealth Literacy levels
Ability of the patients to find, understand and use information to improve their health from electronic sources using the eHLQ questionnaire
Time frame: up to 12 months after randomization
To evaluate the implementation process including the adoption of the HOPE digitally enabled supportive care pathway (Resilience mobile application)
Information on digital health adoption and implementation process will be measured by different criteria: \- Willingness rate (Resilience© digital companion): will be defined as the rate of patients that activated a Resilience account adoption rate (Resilience© digital companion): will be defined as the rate of users who used Resilience as intended Full digital usage experience: using the experience questionnaire developped for the study
Time frame: up to 12 weeks of intervention
To evaluate the patient experience in using a web platform (WeShare) for collecting ePROs data.
Using the experience questionnaire developped for the study and the French System Usability Scale
Time frame: up to 12 weeks of intervention
To evaluate the impact of the intervention on physical activity levels measured by a wearable device;
Physical activity levels will be captured through a wearable device (number of steps, distance in Km and calories burned) (Withings © Pulse HR smartwatch)
Time frame: up to 12 weeks of intervention
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gustave Roussy, Cancer Campus, Grand Paris