Breast CancerNCT07524829
Telenursing for the Early Detection and Management of Side Effects Associated With Cyclin-Dependent Kinase Inhibitors in Breast Cancer Patients
A study testing Structured Telenursing Follow-up and Standard Nursing Care in people with Breast Cancer and Drug-Related Side Effects and Adverse Reactions, run by Azienda Sanitaria Locale di Asti at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Drug-Related Side Effects and Adverse Reactions, Chemotherapy Toxicity
- What is being tested?
- Structured Telenursing Follow-up and Standard Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteItaly
- Study dates
- 9 Apr 2024to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Cardinal Massaia Hospital - S.C. Oncology, Azienda Sanitaria Locale AT (ASL AT)
Asti, ASTI, 14100
MANUELA CANICATTI', RN, MSc, PhD(c), +39 03297278131 ext. +39 0141486557, mcanicatti@asl.at.it
MANUELA CANICATTi', RN, MSc, PhD(c)
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer, Drug-Related Side Effects and Adverse Reactions, Chemotherapy Toxicity, Treatment Adherence, Treatment-Related Toxicity
- Being tested
- Structured Telenursing Follow-up, Standard Nursing Care
- Keywords
- Breast Cancer, Telenursing, Telemedicine, Cyclin-Dependent Kinase Inhibitors, CDK4/6 Inhibitors, Treatment Toxicity, Adverse Events, Supportive Care, Treatment Adherence, Oncology Nursing
- Medical subject headings
- Breast Neoplasms, Drug-Related Side Effects and Adverse Reactions, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Telenursing Follow-upBehavioural
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.
Standard Nursing CareOther
Routine clinical and nursing care provided according to standard local practice, including scheduled outpatient visits and patient-initiated contacts as needed.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Participants receive routine clinical and nursing management according to standard local practice during treatment with CDK inhibitors. Receives: 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. Receives: Behavioral: Structured Telenursing Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From treatment initiation up to 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start9 Apr 2024
- Primary completionApr 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale di Asti
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- MANUELA CANICATTI', RN, MSc, PhD(c), Principal investigator, ASL ATMichela PIREDDA, RN, MSc, PhD, Study director, University of Rome Tor Vergata, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524829
- Sponsor's protocol ID
- Nursing-PREEFFECT
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Yahyaei A, Madani T, Vesali S, Mashayekhi M. Intrauterine infusion of autologous platelet rich plasma can be an efficient treatment for patients with unexplained recurrent implantation failure. Sci Rep. 2024 Oct 29;14(1):26009. doi: 10.1038/s41598-024-77578-1.
PubMed 39472511Hsieh 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.
PubMed 36264639Robinson 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.
PubMed 33958197Courtin-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.
PubMed 26776934Sood 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.
PubMed 24706053
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NURSING-Preeffect: Telenursing for the Early Detection and Management of Side Effects Associated With Cyclin-Dependent Kinase Inhibitors in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07524829
- Acronym / sponsor ID
- Nursing-PREEFFECT
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale di AstiOther government
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Standard Nursing CareParticipants receive routine clinical and nursing management according to standard local practice during treatment with CDK inhibitors. |
| Telenursing Intervention | Experimental | Behavioral: Structured Telenursing Follow-upParticipants receive routine care plus a structured telenursing follow-up program with scheduled remote nursing contacts during treatment with CDK inhibitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Telenursing Follow-upA 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. | Behavioural | Telenursing Intervention |
| Standard Nursing CareRoutine clinical and nursing care provided according to standard local practice, including scheduled outpatient visits and patient-initiated contacts as needed. | Other | Standard Care |
Primary outcome
Incidence of treatment-related adverse events assessed by CTCAE (v5.0)
Time frame: From treatment initiation up to 6 months
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.
5 secondary outcomes
Severity of adverse events assessed by CTCAE (v5.0)
Time frame: Up to 6 months
Treatment adherence assessed by dose intensity and treatment interruptions
Time frame: Up to 6 months
Rate of unplanned hospital visits related to treatment toxicity
Time frame: Up to 6 months
Quality of life assessed by EORTC QLQ-C30 questionnaire
Time frame: Baseline to 6 months
Time to detection of adverse events (patient-reported vs clinically identified)
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 39472511Yahyaei A, Madani T, Vesali S, Mashayekhi M. Intrauterine infusion of autologous platelet rich plasma can be an efficient treatment for patients with unexplained recurrent implantation failure. Sci Rep. 2024 Oct 29;14(1):26009. doi: 10.1038/s41598-024-77578-1.
- Background: PubMed 36264639Hsieh 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.
- Background: PubMed 33958197Robinson 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.
- Background: PubMed 26776934Courtin-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.
- Background: PubMed 24706053Sood 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MANUELA CANICATTI', RN, MSc, PhD(c) principal investigator
ASL AT
Michela PIREDDA, RN, MSc, PhD study director
University of Rome Tor Vergata, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Telenursing Follow-up and Standard Nursing Care in people with Breast Cancer and Drug-Related Side Effects and Adverse Reactions, run by Azienda Sanitaria Locale di Asti at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MANUELA CANICATTI', RN, MSc, PhD(c) (+39 3297278131 ext. +39 0141486557, mcanicatti@asl.at.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related adverse events assessed by CTCAE (v5.0) (time frame: From treatment initiation up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07524829, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.