Breast CancerPhase 3HOPENCT06781996
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
A Phase 3 study testing multimodal Resilience© digital companion and Standard supportive care in people with Breast Cancer and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- multimodal Resilience© digital companion and Standard supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2025to 15 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 20Show fewer
- 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;
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif
Ines Vas-luis, +33142114211 ext. 4827, INES-MARIA.VAZ-DUARTE-LUIS@gustaveroussy.fr
About this study
Official title: Phase III Randomized Controlled Open Label Clinical Trial 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
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.
- Being tested
- multimodal Resilience© digital companion, Standard supportive care
- Keywords
- early stage breast cancer, Hormone-receptor positive, endocrine therapy-related adverse events
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal Resilience© digital companionOther
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 careOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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;
Measured: 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);
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: up to 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start9 Sep 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Resilience, WeShare, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Ines VAZ-LUIS, MD, Study director, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781996
- Sponsor's protocol ID
- 2024-A01127-40
- Other IDs
- 2024/3897
- Acronym
- HOPE
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Franzoi MA, Michels S, Ball S, Barbier A, Serhal C, Bernatowiez A, Ferreira A, D'Andon JF, Gernier F, Morel A, Demetz J, Le Du F, Lapidari P, Vaz-Luis I. Multicenter randomized effectiveness/implementation trial of a digital self-management support tool to improve the quality of life during adjuvant hormonal therapy for patients with early breast cancer: The HOPE trial. Contemp Clin Trials. 2026 Jul 25;169:108407. doi: 10.1016/j.cct.2026.108407. Online ahead of print.
PubMed 42501860
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Controlled Open Label Clinical Trial 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
- ClinicalTrials.gov ID
- NCT06781996
- Acronym / sponsor ID
- HOPE / 2024-A01127-40
- Keywords
- early stage breast cancer, Hormone-receptor positive, endocrine therapy-related adverse events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- Resilience, WeShare, National Cancer Institute, France
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard supportive care and multimodal Resilience© digital companion with digital self care program | Experimental | Other: multimodal Resilience© digital companion, Other: Standard supportive carePatients 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. |
| Standard supportive care | Active comparator | Other: Standard supportive carePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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;
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimodal Resilience© digital companionResilience© 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 | Other | Standard supportive care and multimodal Resilience© digital companion with digital self care program |
| Standard supportive carestandard 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, Standard supportive care and multimodal Resilience© digital companion with digital self care program |
Primary outcome
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
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.
8 secondary outcomes
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;
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
Time frame: up to 12 months after randomization
To evaluate the impact of the intervention on the perceived self-efficacy of symptom management;
Time frame: up to 12 months after randomization
To evaluate the impact of the intervention on eHealth Literacy levels
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)
Time frame: up to 12 weeks of intervention
To evaluate the patient experience in using a web platform (WeShare) for collecting ePROs data.
Time frame: up to 12 weeks of intervention
To evaluate the impact of the intervention on physical activity levels measured by a wearable device;
Time frame: up to 12 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Derived from this study: PubMed 42501860Franzoi MA, Michels S, Ball S, Barbier A, Serhal C, Bernatowiez A, Ferreira A, D'Andon JF, Gernier F, Morel A, Demetz J, Le Du F, Lapidari P, Vaz-Luis I. Multicenter randomized effectiveness/implementation trial of a digital self-management support tool to improve the quality of life during adjuvant hormonal therapy for patients with early breast cancer: The HOPE trial. Contemp Clin Trials. 2026 Jul 25;169:108407. doi: 10.1016/j.cct.2026.108407. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ines VAZ-LUIS, MD study director
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing multimodal Resilience© digital companion and Standard supportive care in people with Breast Cancer and Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Alice FRANZOI, MD (+33142114211 ext. 48 27, Mariaalice.BORINELLI-FRANZOI@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06781996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.