NURSING-Preeffect: Telenursing for the Early Detection and Management of Side Effects Associated With Cyclin-Dependent Kinase Inhibitors in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Incidence of treatment-related adverse events assessed by CTCAE (v5.0)
研究概览
简要总结
This study is a multicenter randomized controlled trial designed to evaluate the effectiveness of a structured telenursing intervention in patients with breast cancer receiving cyclin-dependent kinase (CDK) inhibitor therapy.
Patients undergoing treatment with CDK inhibitors frequently experience adverse effects that may negatively impact treatment adherence, quality of life, and clinical outcomes. Early detection and timely management of these side effects are essential to optimize therapy and reduce complications, including unplanned hospitalizations and treatment interruptions.
In this study, participants are randomly assigned to one of two groups: standard care or standard care plus a structured telenursing follow-up program. The intervention consists of scheduled remote contacts (telephone or video consultations) conducted by trained nursing staff at predefined time points during treatment. These contacts aim to monitor symptoms, provide education, reinforce adherence, and facilitate early identification and management of treatment-related toxicities.
The primary objective of the study is to assess whether the telenursing intervention reduces the incidence and severity of treatment-related adverse events compared to standard care alone. Secondary objectives include evaluating its impact on emergency department visits, hospitalizations, treatment adherence, dose intensity, and patient-reported outcomes.
The study is currently recruiting participants across multiple centers. Results from this trial may provide evidence to support the integration of structured telenursing programs into routine oncology care, with the potential to improve patient safety, treatment continuity, and overall clinical outcomes.
详细描述
Breast cancer patients receiving cyclin-dependent kinase (CDK) inhibitors represent a growing population in oncology practice. These therapies, although highly effective, are frequently associated with a range of treatment-related adverse events, including hematologic toxicities (such as neutropenia), gastrointestinal symptoms, fatigue, and other systemic effects. These side effects may lead to treatment interruptions, dose reductions, decreased adherence, and increased healthcare utilization, including unplanned emergency department visits and hospitalizations.
Early detection and proactive management of treatment-related toxicities are essential to ensure treatment continuity and optimize clinical outcomes. In routine clinical practice, however, symptom monitoring is often limited to scheduled outpatient visits, which may delay the identification and management of adverse events. Innovative care models, including telemedicine and telenursing interventions, have been proposed to enhance patient monitoring and support between visits.
The present study (NURSING PRE-EFFECT) is a multicenter, randomized, controlled, open-label clinical trial designed to evaluate the effectiveness of a structured telenursing intervention in patients with breast cancer undergoing treatment with CDK inhibitors. The study aims to assess whether the integration of scheduled remote nursing follow-up can improve early detection and management of treatment-related adverse events and positively influence clinical outcomes.
This study is a randomized, parallel-group interventional trial. Participants are prospectively assigned to one of two arms using a computerized randomization system: (1) a telenursing intervention group receiving standard care plus a structured telenursing program, and (2) a control group receiving standard care alone.
Standard care consists of routine clinical and nursing management according to local practice at each participating center. The study aims to compare the effectiveness of the telenursing intervention in improving early detection and management of treatment-related adverse events.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥18 years
- •Histologically confirmed breast cancer
- •Ongoing treatment with CDK 4/6 inhibitors (e.g., palbociclib, ribociclib, abemaciclib)
- •Ability to understand and provide informed consent
- •Access to a telephone or digital communication device for telenursing follow-up
排除标准
- •Inability to comply with the study procedures
- •Cognitive impairment or psychiatric conditions interfering with participation
- •Participation in another interventional clinical trial that may affect study outcomes
- •Severe comorbidities limiting life expectancy or follow-up
研究组 & 干预措施
Standard Care
Participants receive routine clinical and nursing management according to standard local practice during treatment with CDK inhibitors.
干预措施: Standard Nursing Care (Other)
Telenursing Intervention
Participants receive routine care plus a structured telenursing follow-up program with scheduled remote nursing contacts during treatment with CDK inhibitors.
干预措施: Structured Telenursing Follow-up (Behavioral)
结局指标
主要结局
Incidence of treatment-related adverse events assessed by CTCAE (v5.0)
时间窗: From treatment initiation up to 6 months
Incidence of treatment-related adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, during CDK 4/6 inhibitor therapy.
次要结局
- Severity of adverse events assessed by CTCAE (v5.0)(Up to 6 months)
- Treatment adherence assessed by dose intensity and treatment interruptions(Up to 6 months)
- Rate of unplanned hospital visits related to treatment toxicity(Up to 6 months)
- Quality of life assessed by EORTC QLQ-C30 questionnaire(Baseline to 6 months)
- Time to detection of adverse events (patient-reported vs clinically identified)(Up to 6 months)