Trials / Recruiting

RecruitingNCT07524829

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

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 124 (estimated)

Sponsor: Azienda Sanitaria Locale di Asti · Other Government
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. The experimental intervention consists of a structured telenursing follow-up program delivered by trained oncology nurses. The program includes scheduled remote contacts (telephone calls or video consultations) at predefined time points during treatment (e.g., at approximately day 7, day 14, and day 21 of each treatment cycle, or according to protocol specifications). During these contacts, nurses systematically assess patient-reported symptoms, monitor treatment-related toxicities, provide education on symptom management, reinforce treatment adherence, and identify early warning signs requiring clinical intervention. When clinically relevant symptoms or adverse events are identified, patients are promptly referred to the treating physician or appropriate healthcare services for further evaluation and management, according to predefined clinical pathways. This proactive approach aims to reduce delays in care, prevent worsening of toxicities, and minimize the need for acute care services. The primary objective of the study is to evaluate the effect of the telenursing intervention on the incidence and severity of treatment-related adverse events, assessed using standardized criteria (e.g., Common Terminology Criteria for Adverse Events, CTCAE). Secondary objectives include: evaluation of the impact on unplanned emergency department visits and hospitalizations; assessment of treatment adherence and relative dose intensity; evaluation of treatment modifications (dose reductions, delays, or discontinuations); assessment of patient-reported outcomes, including quality of life and satisfaction with care; evaluation of healthcare resource utilization. Data are collected prospectively using standardized case report forms and institutional electronic health records. Clinical, treatment-related, and outcome data are recorded at baseline, during treatment, and at predefined follow-up time points. The study is conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval has been obtained from the competent Ethics Committee, and all participants provide written informed consent prior to enrollment. This trial is expected to provide evidence on the effectiveness of structured telenursing interventions in oncology, supporting the integration of remote nursing care models into routine clinical practice. If effective, this approach may contribute to improving patient safety, enhancing treatment adherence, reducing healthcare utilization, and optimizing overall outcomes in patients receiving CDK inhibitor therapy.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2024-04-09
Primary completion: 2028-04-01
Completion: 2028-09-01
First posted: 2026-04-13
Last updated: 2026-04-13

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT07524829. Inclusion in this directory is not an endorsement.