Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy Toxicity | — | UNRESOLVED | — |
| Drug-Related Side Effects and Adverse Reactions | — | UNRESOLVED | — |
| Treatment Adherence | — | UNRESOLVED | — |
| Treatment-Related Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Nursing Care | Other | — | UNRESOLVED |
| Structured Telenursing Follow-up | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Care
- description
- Participants receive routine clinical and nursing management according to standard local practice during treatment with CDK inhibitors.
- interventionNames
- Other: Standard Nursing Care
- type
- EXPERIMENTAL
- label
- Telenursing Intervention
- description
- Participants receive routine care plus a structured telenursing follow-up program with scheduled remote nursing contacts during treatment with CDK inhibitors.
- interventionNames
- Behavioral: Structured Telenursing Follow-up
Primary outcomes (1)
- measure
- Incidence of treatment-related adverse events assessed by CTCAE (v5.0)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
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