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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: multimodal Resilience© digital companion (Other)
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.
干预措施: Standard supportive care (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.
干预措施: Standard supportive care (Other)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
- To evaluate the implementation process including the adoption of the HOPE digitally enabled supportive care pathway (Resilience mobile application)(up to 12 weeks of intervention)
- To evaluate the patient experience in using a web platform (WeShare) for collecting ePROs data.(up to 12 weeks of intervention)
- To evaluate the impact of the intervention on physical activity levels measured by a wearable device;(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;(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)
- To evaluate the implementation process including the adoption of the HOPE digitally enabled supportive care pathway (Resilience mobile application)(up to 12 weeks of intervention)
- To evaluate the patient experience in using a web platform (WeShare) for collecting ePROs data.(up to 12 weeks of intervention)
- To evaluate the impact of the intervention on physical activity levels measured by a wearable device;(up to 12 weeks of intervention)