RecruitingNot ApplicableNCT07524829

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


Sponsor

Azienda Sanitaria Locale di Asti

Enrollment

124 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This multicenter randomized controlled trial evaluates whether a structured telenursing program — scheduled phone or video check-ins with trained oncology nurses — can help breast cancer patients on CDK 4/6 inhibitor therapy (such as palbociclib, ribociclib, or abemaciclib) detect and manage treatment side effects earlier, reducing hospital visits and treatment interruptions. CDK inhibitors are effective but often cause side effects like low white blood cell counts and fatigue that can disrupt treatment. Eligible participants are adult women (18 or older) with histologically confirmed breast cancer who are currently receiving CDK 4/6 inhibitor therapy, have access to a phone or digital device, and can provide informed consent; those with severe cognitive impairment or concurrent interventional trials are excluded. Participation involves being randomly assigned to receive either standard oncology care or standard care plus scheduled nursing follow-up calls at set points during each treatment cycle. This summary was prepared using AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALStructured 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.

OTHERStandard Nursing Care

Routine clinical and nursing care provided according to standard local practice, including scheduled outpatient visits and patient-initiated contacts as needed.


Locations(1)

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

Asti, ASTI, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07524829


Related Trials