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.
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
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
Parallel
Structured Telenursing Follow-up
BehavioralA structured telenursing follow-up program consisting of scheduled telephone or video consultations conducted by trained oncology nurses during treatment with CDK inhibitors. The intervention includes systematic symptom assessment, patient education, adherence support, and early identification and management of treatment-related adverse events.
Standard Nursing Care
Other interventionRoutine clinical and nursing care provided according to standard local practice, including scheduled outpatient visits and patient-initiated contacts as needed.
Incidence of treatment-related adverse events assessed by CTCAE (v5.0)
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.
Severity of adverse events assessed by CTCAE (v5.0)
Incidence of treatment-related adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events will be classified by grade (1-5), with higher grades indicating increased severity.
Treatment adherence assessed by dose intensity and treatment interruptions
Treatment adherence evaluated as relative dose intensity (RDI), expressed as the percentage of the prescribed dose actually received (0-100%), with higher values indicating better adherence.
Rate of unplanned hospital visits related to treatment toxicity
Number of unplanned emergency department visits or hospital admissions related to treatment-related adverse events during the study period.
Quality of life assessed by EORTC QLQ-C30 questionnaire
Patient-reported quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores range from 0 to 100; higher scores indicate better functioning for functional scales and worse symptom burden for symptom scales.
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