Clinical trial NCT06781996: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
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
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
Collaborators: name: Resilience
name: WeShare
name: National Cancer Institute, France
First posted: 2025-01-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. Documentation of Disease:

   1. Subjects must have histologically confirmed ER and/or PgR positive HR+ invasive BC;
   2. 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;
2. Indication to receive adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) with or without targeted agents (e.g., CDK 4/6 inhibitors, PARP inhibitors, bisphosphonates);
3. 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;
4. Documentation of side effects of ongoing ET: Any endocrine therapy related adverse effects should be reported during treatment with endocrine therapy;
5. Others:

   1. Age ≥ 18 years;
   2. ECOG Performance Status 0,1 or 2;
   3. Patients should possess a smartphone;
   4. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed;
   5. Patient should be able and willing to comply with study visits and procedures as per protocol;
   6. Patients must be affiliated to a social security system or beneficiary of the same;
   7. 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.

Exclusion Criteria:

1. 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;
2. Patient under guardianship or deprived of her/his liberty by a judicial or administrative decision or incapable of giving her/his consent;
3. Patients participating at enrollment in a behavioral interventional trial;
4. 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.

Primary outcomes:
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.
timeFrame: up to 12 weeks of intervention
Secondary outcomes:
measure: To evaluate the impact of the intervention on other EORTC QLQ-C30 domains, including fatigue, emotional distress, pain, and sleep quality;
timeFrame: after 12 months of randomization
measure: To evaluate the impact of the intervention on insomnia measured by a wearable device;
timeFrame: up to 12 months after randomization
measure: To evaluate the impact of the intervention on adherence to endocrine therapy, assessed through the modified MIS-A questionnaire
timeFrame: up to 12 months after randomization
measure: To evaluate the impact of the intervention on the perceived self-efficacy of symptom management;
timeFrame: up to 12 months after randomization
measure: To evaluate the impact of the intervention on eHealth Literacy levels
timeFrame: up to 12 months after randomization
measure: To evaluate the implementation process including the adoption of the HOPE digitally enabled supportive care pathway (Resilience mobile application)
timeFrame: up to 12 weeks of intervention
measure: To evaluate the patient experience in using a web platform (WeShare) for collecting ePROs data.
timeFrame: up to 12 weeks of intervention
measure: To evaluate the impact of the intervention on physical activity levels measured by a wearable device;
timeFrame: up to 12 weeks of intervention
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Ines VAZ-LUIS, MD
role: STUDY_DIRECTOR
References: