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 | Recruiting Phase 3

• 2 other identifiers: 2024-A01127-402024/3897
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

early stage breast cancer; Hormone-receptor positive; endocrine therapy-related adverse events

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 12 weeks of intervention

Secondary Outcomes (8)

• To evaluate the impact of the intervention on other EORTC QLQ-C30 domains, including fatigue, emotional distress, pain, and sleep quality;

  after 12 months of randomization

• To evaluate the impact of the intervention on insomnia measured by a wearable device;

  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

  up to 12 months after randomization

• To evaluate the impact of the intervention on the perceived self-efficacy of symptom management;

  up to 12 months after randomization

• To evaluate the impact of the intervention on eHealth Literacy levels

  up to 12 months after randomization

Study Arms (2)

Standard supportive care and multimodal Resilience© digital companion with digital self care program

EXPERIMENTAL

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

Standard supportive care

ACTIVE COMPARATOR

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

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 and multimodal Resilience© digital companion with digital self care program

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.

Standard supportive care; Standard supportive care and multimodal Resilience© digital companion with digital self care program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documentation of Disease:
• 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;
• 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;
• 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;
• Documentation of side effects of ongoing ET: Any endocrine therapy related adverse effects should be reported during treatment with endocrine therapy;
• Others:
• Age ≥ 18 years;
• ECOG Performance Status 0,1 or 2;
• Patients should possess a smartphone;
• Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed;
• Patient should be able and willing to comply with study visits and procedures as per protocol;
• Patients must be affiliated to a social security system or beneficiary of the same;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• Resilience: collaborator
• WeShare: collaborator
• National Cancer Institute, France: collaborator

Study Sites (1)

Gustave Roussy

Villejuif, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ines VAZ-LUIS, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY DIRECTOR

Central Study Contacts

Maria Alice FRANZOI, MD

CONTACT

+33142114211; Mariaalice.BORINELLI-FRANZOI@gustaveroussy.fr

Chloé Serhal, PhD

CONTACT

+33142114211; Chloé.serhal@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model 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.

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 17, 2025
• Study Start: September 9, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-01

Locations

FR (1)