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

NCT07524829 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Azienda Sanitaria Locale di Asti

    lead OTHER_GOV

Principal Investigators

  • MANUELA CANICATTI', RN, MSc, PhD(c) · ASL AT

  • Michela PIREDDA, RN, MSc, PhD · University of Rome Tor Vergata, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-09
Primary Completion
2028-04-30
Completion
2028-09-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07524829 on ClinicalTrials.gov