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

NCT07524829 | Recruiting

• 1 other identifier: Nursing-PREEFFECT
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast Cancer; Telenursing; Telemedicine; Cyclin-Dependent Kinase Inhibitors; CDK4/6 Inhibitors; Treatment Toxicity; Adverse Events; Supportive Care; Treatment Adherence; Oncology Nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Severity of adverse events assessed by CTCAE (v5.0)

  Up to 6 months

• Treatment adherence assessed by dose intensity and treatment interruptions

  Up to 6 months

• Rate of unplanned hospital visits related to treatment toxicity

  Up to 6 months

• Quality of life assessed by EORTC QLQ-C30 questionnaire

  Baseline to 6 months

• Time to detection of adverse events (patient-reported vs clinically identified)

  Up to 6 months

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Participants receive routine clinical and nursing management according to standard local practice during treatment with CDK inhibitors.

Other: Standard Nursing Care

Telenursing Intervention

EXPERIMENTAL

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

Interventions

Structured Telenursing Follow-up BEHAVIORAL

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.

Telenursing Intervention

Standard Nursing Care OTHER

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

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Locale di Asti: lead

Study Sites (1)

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

Asti, ASTI, 14100, Italy

RECRUITING

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  PMID: 36264639 BACKGROUND

• 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.

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• 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.

  PMID: 26776934 BACKGROUND

• 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.

  PMID: 24706053 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Drug-Related Side Effects and Adverse Reactions; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Chemically-Induced Disorders; Health Behavior; Behavior

Study Officials

• MANUELA CANICATTI', RN, MSc, PhD(c)

  ASL AT

  PRINCIPAL INVESTIGATOR

• Michela PIREDDA, RN, MSc, PhD

  University of Rome Tor Vergata, Italy

  STUDY DIRECTOR

Central Study Contacts

MANUELA CANICATTI', RN, MSc, PhD(c)

CONTACT

+39 3297278131; mcanicatti@asl.at.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either the telenursing intervention group or the standard care group using a computerized allocation system. The study follows a parallel assignment design with two arms.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 13, 2026
• Study Start: April 9, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)