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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Drug-Related Side Effects and Adverse Reactions; Treatment Adherence; Chemotherapy Toxicity; Treatment-Related Toxicity
• Intervention / Treatment: Other: Standard Nursing Care; Behavioral: Structured Telenursing Follow-up

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.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MANUELA CANICATTI', RN, MSc, PhD(c); Phone Number: +39 0141486557 +39 3297278131; Email: mcanicatti@asl.at.it

Study Locations

• Italy
  • ASTI
    • Asti, ASTI, Italy, 14100
      • Recruiting
      • Cardinal Massaia Hospital - S.C. Oncology, Azienda Sanitaria Locale AT (ASL AT)
      • Contact: MANUELA CANICATTI', RN, MSc, PhD(c); Phone Number: +39 0141486557 +39 03297278131; Email: mcanicatti@asl.at.it
      • Principal Investigator: MANUELA CANICATTi', RN, MSc, PhD(c)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care; Participants receive routine clinical and nursing management according to standard local practice during treatment with CDK inhibitors.	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.
Experimental: Telenursing Intervention; Participants receive routine care plus a structured telenursing follow-up program with scheduled remote nursing contacts during treatment with CDK inhibitors.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From treatment initiation up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months
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.	Up to 6 months
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.	Up to 6 months
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.	Baseline to 6 months
Time to detection of adverse events (patient-reported vs clinically identified)	Time interval between patient-reported onset of symptoms and clinical identification of treatment-related adverse events, measured in days.	Up to 6 months

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale di Asti
• Investigators: Principal Investigator: MANUELA CANICATTI', RN, MSc, PhD(c), ASL AT; Study Director: Michela PIREDDA, RN, MSc, PhD, University of Rome Tor Vergata, Italy

Publications and helpful links

General Publications

• Yahyaei A, Madani T, Vesali S, Mashayekhi M. Intrauterine infusion of autologous platelet rich plasma can be an efficient treatment for recurrent implantation failure. Sci Rep. 2024;14(1):26009.
• Hsieh CY, Lin CC, Huang YW, Chen JH, Tsou YA, Chang LC, Fan CC, Lin CY, Chang WC. Macrophage secretory IL-1beta promotes docetaxel resistance in head and neck squamous carcinoma via SOD2/CAT-ICAM1 signaling. JCI Insight. 2022 Dec 8;7(23):e157285. doi: 10.1172/jci.insight.157285.
• Robinson NB, Gaudino M. Commentary: Acute type A dissection and sex: A matter of biology or of imperfect adjustment? J Thorac Cardiovasc Surg. 2023 Mar;165(3):982-983. doi: 10.1016/j.jtcvs.2021.04.005. Epub 2021 Apr 12. No abstract available.
• Courtin-Tanguy L, Rayar M, Bergeat D, Merdrignac A, Harnoy Y, Boudjema K, Meunier B, Sulpice L. The true prognosis of resected distal cholangiocarcinoma. J Surg Oncol. 2016 Apr;113(5):575-80. doi: 10.1002/jso.24165. Epub 2016 Jan 18.
• Sood A, Midha V, Goyal O, Goyal P, Sood P, Sharma SK, Sood N. Skin and soft tissue infections in cirrhotics: a prospective analysis of clinical presentation and factors affecting outcome. Indian J Gastroenterol. 2014 May;33(3):281-4. doi: 10.1007/s12664-014-0454-2. Epub 2014 Apr 5.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Telemedicine; Breast Cancer; Supportive Care; Adverse Events; Treatment Adherence; Telenursing; Oncology Nursing; CDK4/6 Inhibitors; Treatment Toxicity; Cyclin-Dependent Kinase Inhibitors
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Chemically-Induced Disorders; Skin Diseases; Breast Diseases; Behavior; Skin and Connective Tissue Diseases; Health Behavior; Breast Neoplasms; Drug-Related Side Effects and Adverse Reactions; Treatment Adherence and Compliance
• Other Study ID Numbers: Nursing-PREEFFECT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to privacy and confidentiality restrictions. The dataset contains sensitive clinical information, and data sharing is not planned within the scope of this study. Aggregated results will be disseminated through scientific publications and presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No