Telenursing to detect and manage side effects from CDK4/6 inhibitors in breast cancer
Official title: NURSING-Preeffect: Telenursing for the Early Detection and Management of Side Effects Associated With Cyclin-Dependent Kinase Inhibitors in Breast Cancer Patients
Run by Azienda Sanitaria Locale di Asti · NCT07524829 · Data updated 2026-11-12
This project tests whether scheduled phone or video contacts from trained nurses, added to usual care, help people with breast cancer taking CDK4/6 inhibitors notice and manage side effects earlier and stay on treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 124 (estimated) |
| Sponsor | Azienda Sanitaria Locale di Asti Government |
| Locations | 1 site (Asti, ASTI) |
| Status | Recruiting |
| Started | April 9, 2024 |
| Main results expected | April 2028 |
| Study ends | September 2028 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07524829 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women with histologically confirmed breast cancer who are currently receiving a CDK4/6 inhibitor (e.g., palbociclib, ribociclib, abemaciclib) and have access to a telephone or digital device are ideal candidates.
✕Probably not a fit
Patients without reliable access to phone/video communication, those with severe cognitive or psychiatric impairment preventing participation, or those not receiving CDK4/6 inhibitors are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized, open-label trial comparing standard care alone versus standard care plus a structured telenursing follow-up program for patients receiving CDK4/6 inhibitors. Participants are randomly assigned to receive scheduled remote contacts (telephone or video) by trained nursing staff at predefined time points to monitor symptoms, provide education, and reinforce adherence. The intervention aims to enable earlier detection and management of common toxicities such as neutropenia, gastrointestinal symptoms, and fatigue, with the goal of reducing treatment interruptions and unplanned healthcare use. Outcomes include measures of symptom detection, treatment adherence, and healthcare utilization.
Why it matters
Potential benefit: If successful, the program could lead to earlier symptom detection, fewer unplanned hospital visits, better treatment adherence, and fewer dose reductions or interruptions.
How similar studies have gone: Telemedicine and telenursing interventions in oncology have shown benefits for symptom monitoring and adherence in prior research, though specific data focused on CDK4/6 inhibitor side effects are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Cardinal Massaia Hospital - S.C. Oncology, Azienda Sanitaria Locale AT (ASL AT)
Asti, Asti, Italy Recruiting
Study contacts
- Principal investigator: MANUELA CANICATTI', RN, MSc, PhD(c) — Asl at
- Study coordinator: MANUELA CANICATTI', RN, MSc, PhD(c)
- Email: mcanicatti@asl.at.it
- Phone: +39 3297278131
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.