Recruiting

Telenursing for the Early Detection and Management of Side Effects Associated With Cyclin-Dependent Kinase Inhibitors in Breast Cancer Patients

ClinicalTrials.gov IDNCT07524829

PhaseNA

Enrollment124

SponsorAzienda Sanitaria Locale di Asti

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer, Drug-Related Side Effects and Adverse Reactions, Chemotherapy Toxicity, Treatment Adherence, Treatment-Related Toxicity

About this study

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.

Interventions

Behavioral: Structured Telenursing Follow-up — A 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.
Other: Standard Nursing Care — Routine clinical and nursing care provided according to standard local practice, including scheduled outpatient visits and patient-initiated contacts as needed.

Primary outcomes

Incidence of treatment-related adverse events assessed by CTCAE (v5.0) (From treatment initiation up to 6 months)

Eligibility information

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations

Cardinal Massaia Hospital - S.C. Oncology, Azienda Sanitaria Locale AT (ASL AT), Asti, ASTI 14100 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.