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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT06781996
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • multimodal Resilience© digital companion — OTHER
    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 — OTHER
    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 Details

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.

Key Dates

Start date
Sep 9, 2025
Status verified
Jan 2025
Primary completion
Mar 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Standard supportive care and multimodal Resilience© digital companion with digital self care program
    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.
  • Active Comparator: 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.

Primary Outcome Measure

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. [ Time Frame: up to 12 weeks of intervention ]

Central Contacts

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