Prevalence of treatment-related adverse events (TRAEs) with antibody-drug conjugates in metastatic breast cancer patients: A systematic review and meta-analysis.

Antibody-drug conjugates (ADCs) are revolutionizing metastatic breast cancer treatment, resulting in a better prognosis and a higher safety profile than chemotherapy. Nevertheless, treatment-related adverse events (TRAE) have been extensively documented. We searched five databases for articles published up to December 2023 and conducted a meta-analysis on 23 clinical trials to estimate TRAE prevalence related to currently approved ADCs. The prevalence of the most common TRAEs ranged from 12 % to 33 %, depending on the ADC type and study design. Gastrointestinal disorders were highly prevalent during Trastuzumab Deruxtecan, general disorders were extremely common during Trastuzumab Emtansine, and blood system disorders and gastrointestinal disorders were the most prevalent during Sacituzumab Govitecan. This study provides an estimate of ADC-related TRAEs for each treatment based on study design. Despite each ADC having specific toxicities, gastrointestinal symptoms were highly prevalent in all treatments. This study lays the groundwork for developing personalized risk-stratified care pathways.

Identifying Clusters of Curatively-Treated Esophageal Cancer Patients Using Patient-Reported Outcome Measures at Three Months from Discharge: A Secondary Analysis from a Longitudinal Single Center Study.

AIM: This study aims to identify meaningful clusters based on Patient-Reported Outcome Measures (PROMs) in curatively-treated esophageal cancer patients at three months post-discharge. METHODS: This secondary analysis of a longitudinal single-center study included 46 esophageal cancer patients who underwent curative surgery. Patients were selected based on their completion of PROMs surveys at three months post-discharge, were aged 18 years or older, and had undergone surgical resection (esophagectomy) with or without neoadjuvant chemotherapy and/or radiotherapy. The analysis utilized t-distributed Stochastic Neighbor Embedding (t-SNE) for dimensionality reduction and hierarchical clustering to analyze PROMs data collected three months post-discharge. Clustering was performed on physical, emotional, cognitive, and social functioning variables, symptom burden, and health literacy. RESULTS: Three distinct clusters were identified: Cluster 1 (n = 24) with higher functioning and moderate symptoms, Cluster 2 (n = 14) with moderate functioning, higher symptoms, and lower health literacy, and Cluster 3 (n = 8) with the highest functioning, lowest symptoms, and highest health literacy. Significant differences between squamous cell carcinoma and adenocarcinoma subtypes were observed across several PROMs domains, including critical health literacy, general health status/quality of life, nausea and vomiting, and insomnia. These clusters provide an exploratory framework for tailoring post-operative interventions to enhance patient recovery, which necessitates further confirmatory investigations, including outcomes such as complications and mortality, in the analysis. CONCLUSIONS: This study fills a research gap by demonstrating the utility of PROMs in identifying distinct recovery patterns in esophageal cancer patients post-surgery. The findings support the use of PROMs to guide personalized post-operative care, potentially improving patient outcomes and quality of life. Further research is needed to validate these findings in larger, diverse populations.

Shaping the future research agenda of Cancer Nursing in Italy: Insights and strategic directions.

This report analyzes the evolution of cancer nursing research in Italy, focusing on 207 publications from nursing journals indexed in MEDLINE. Using Latent Dirichlet Allocation, we identified four primary research topics from the included abstracts: Patient-Centered Care, Clinical Nursing Practice, Healthcare Institutions and Systems, and Research and Data Analysis. The temporal trends reveal a shift from foundational studies on healthcare systems in the late 1990s to more recent emphases on patient-centered care and clinical practice. This progression underscores the growing importance of personalized healthcare approaches. Our findings highlight the need for continued investment in innovative nursing interventions and advanced technologies, such as telehealth, to enhance patient outcomes. Research priorities need to investigate how to tailor nursing interventions to individual patient characteristics, such as their cultural background, lifestyle, and personal values, in the area of clinical nursing practice, which is less represented in the literature thus far. The limited publications regarding clinical nursing practice in the Italian context might reflect the need to strengthen cancer nursing as a specialization in Italy to trigger research and practice that address unmet patient needs. The current analysis provides a foundation for future comprehensive studies and strategic development of a research agenda for cancer nursing research in Italy, led by the Italian Association of Cancer Nursing.

[BRCA mutations and decision regret: a comprehensive analysis of existing research through a scoping review and reflections from a nursing perspective.] / Mutazioni BRCA e rimpianto decisionale: un'analisi approfondita della ricerca esistente tramite scoping review e riflessioni da una prospettiva infermieristica.

INTRODUCTION: Given the significance of healthcare decisions in women with BRCA1 and BRCA2 mutations and their impact on patients' lives, this study aims to map the existing literature on decision regret in women with BRCA1 and BRCA2 mutations. METHODS: A scoping review was conducted in the following databases: PubMed, Embase, Scopus, CINAHL, Cochrane, and Google Scholar. Inclusion criteria focused on decision regret in the female population with BRCA1 and/or BRCA2 mutations, with no restrictions on the methodologies of the included studies, but only in the English language. The selection process led to the inclusion of 13 studies. RESULTS: The analysis revealed a significant trend toward decision regret among patients facing complex medical choices. The quality of healthcare communication, decision support, and genetic counselling emerged as key factors influencing patients' perceptions and experiences, with direct implications for their quality of life and psychological well-being. The results suggest that these decisions considerably impact patients, both in terms of clinical outcomes and emotional experiences. DISCUSSION: The investigation highlights the vital importance of a personalized care approach, emphasizing the critical role of managing patients' emotional and psychological complexity. Managing decision regret requires acute attention to individual needs and effective communication to mitigate emotional impact and improve patient outcomes. CONCLUSIONS: Insights from a nursing perspective in the analysis of results indicate the need for informed, empathetic, and integrated care that considers the emotional complexity of women with BRCA1 and/or BRCA2 mutations in their lives and health choices.

Global Trends of Medical Misadventures Using International Classification of Diseases, Tenth Revision Cluster Y62-Y69 Comparing Pre-, Intra-, and Post-COVID-19 Pandemic Phases: Protocol for a Retrospective Analysis Using the TriNetX Platform.

BACKGROUND: The COVID-19 pandemic has sharpened the focus on health care safety and quality, underscoring the importance of using standardized metrics such as the International Classification of Diseases, Tenth Revision (ICD-10). In this regard, the ICD-10 cluster Y62-Y69 serves as a proxy assessment of safety and quality in health care systems, allowing researchers to evaluate medical misadventures. Thus far, extensive research and reports support the need for more attention to safety and quality in health care. The study aims to leverage the pandemic's unique challenges to explore health care safety and quality trends during prepandemic, intrapandemic, and postpandemic phases, using the ICD-10 cluster Y62-Y69 as a key tool for their evaluation. OBJECTIVE: This research aims to perform a comprehensive retrospective analysis of incidence rates associated with ICD-10 cluster Y62-Y69, capturing both linear and nonlinear trends across prepandemic, intrapandemic, and postpandemic phases over an 8-year span. Therefore, it seeks to understand how these trends inform health care safety and quality improvements, policy, and future research. METHODS: This study uses the extensive data available through the TriNetX platform, using an observational, retrospective design and applying curve-fitting analyses and quadratic models to comprehend the relationships between incidence rates over an 8-year span (from 2015 to 2023). These techniques will enable the identification of nuanced trends in the data, facilitating a deeper understanding of the impacts of the COVID-19 pandemic on medical misadventures. The anticipated results aim to outline complex patterns in health care safety and quality during the COVID-19 pandemic, using global real-world data for robust and generalizable conclusions. This study will explore significant shifts in health care practices and outcomes, with a special focus on geographical variations and key clinical conditions in cardiovascular and oncological care, ensuring a comprehensive analysis of the pandemic's impact across different regions and medical fields. RESULTS: This study is currently in the data collection phase, with funding secured in November 2023 through the Ricerca Corrente scheme of the Italian Ministry of Health. Data collection via the TriNetX platform is anticipated to be completed in May 2024, covering an 8-year period from January 2015 to December 2023. This dataset spans pre-pandemic, intra-pandemic, and early post-pandemic phases, enabling a comprehensive analysis of trends in medical misadventures using the ICD-10 cluster Y62-Y69. The final analytics are anticipated to be completed by June 2024. The study's findings aim to provide actionable insights for enhancing healthcare safety and quality, reflecting on the pandemic's transformative impact on global healthcare systems. CONCLUSIONS: This study is anticipated to contribute significantly to health care safety and quality literature. It will provide actionable insights for health care professionals, policy makers, and researchers. It will highlight critical areas for intervention and funding to enhance health care safety and quality globally by examining the incidence rates of medical misadventures before, during, and after the pandemic. In addition, the use of global real-world data enhances the study's strength by providing a practical view of health care safety and quality, paving the way for initiatives that are informed by data and tailored to specific contexts worldwide. This approach ensures the findings are applicable and actionable across different health care settings, contributing significantly to the global understanding and improvement of health care safety and quality. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54838.

Microbiome-Modifiers for Cancer-Related Fatigue Management: A Systematic Review.

OBJECTIVES: This study systematically investigates the evidence regarding the use of probiotics in managing cancer-related fatigue (CRF). STUDY DESIGN: We conducted a systematic review of randomized controlled trials. DATA SOURCES: The systematic search encompassed six databases: PubMed, CINHAL, Cochrane Database of Systematic Reviews, Web of Science, Scopus, and EMBASE, covering the period from inception to December 2023. The assessment of risk of bias employed the Cochrane risk of bias tool (RoB 2). A narrative synthesis and an exploratory meta-analysis were conducted to summarize the evidence. RESULTS: Among 460 records, three studies met the eligibility criteria and were included in the review. These studies involved a total of 284 participants with colorectal and breast cancer. One study demonstrated a marginal improvement in CRF postchemotherapy in colorectal cancer patients using probiotics. Another study, also using probiotics, reported a significant reduction in CRF among colorectal cancer patients undergoing chemotherapy. Additionally, a study employing synbiotics showed a substantial decrease in CRF severity in breast cancer patients receiving chemotherapy. CONCLUSION: The study presents initial but varied evidence suggesting the potential of probiotics and synbiotics as adjunctive therapies in managing CRF alongside anticancer treatments. IMPLICATIONS FOR NURSING PRACTICE: In nursing practice, large-scale clinical trials are urgently needed to evaluate the effectiveness of probiotics in treating cancer-related fatigue during cancer therapy. Insights from this review could guide nurses in selecting appropriate probiotic strains and integrating microbiome modifiers into comprehensive care plans, potentially enhancing the quality of life for cancer patients.

Synbiotics in Oncology: A Scoping Review Protocol on Their Impact and Outcomes in Cancer Care.

Symptom management remains challenging in cancer care. Emerging from nutritional science, nutritional metabolomics has seen exponential growth over recent years, aiming to discern the relationship between dietary habits and health consequences. This protocol aims to present the rationale and methodology for conducting a scoping review to summarize the extent of evidence on synbiotics utilization in cancer symptom management among adults. The scoping review will be undertaken in accordance with the Joanna Briggs Institute (JBI) principles and the research process guided by the PRISMA 2020 scoping reviews extension. The following electronic databases will be searched from the inception: PubMed, Cinahl, Web of Science and Scopus. The authors expect to map the literature regarding the clinical outcomes, including patient-report measures and patient-experience measures, on which the effects of probiotics were tested, and identify potential gaps. This protocol presents a rigorous methodological approach to map the literature on the clinical outcomes that the utilization of synbiotics might improve. This analysis will shape future researchers to examine the efficacy of probiotics on specific clinical outcomes in oncology care. Nurses are uniquely positioned to influence cancer symptom management through the selection and use of appropriate interventions in the field of nutritional supplements, along with nutritional counseling.

Non-pharmacologic interventions for improving cancer-related fatigue (CRF): A systematic review of systematic reviews and pooled meta-analysis.

INTRODUCTION: Literature encloses numerous systematic reviews (SRs) on nonpharmacologic interventions for improving cancer-related fatigue (CRF). The effect of these interventions remains controversial, and the available SRs have not been synthesized yet. We conducted a systematic synthesis of SRs and meta-analysis to determine the effect of nonpharmacologic interventions on CRF in adults. MATERIAL AND METHODS: We systematically searched 4 databases. The effect sizes (standard mean difference) were quantitatively pooled using a random-effects model. Chi-squared (Q) and I-square statistics (I²) tested the heterogeneity. RESULTS: We selected 28 SRs, including 35 eligible meta-analyses. The pooled effect size (standard mean difference, 95% CI) was -0.67 (-1.16, -0.18). The subgroup analysis by types of interventions showed a significant effect in all the investigated approaches (complementary integrative medicine, physical exercise, self-management/e-health interventions). CONCLUSIONS: There is evidence that nonpharmacologic interventions are associated with CRF reduction. Future research should focus on testing these interventions on specific population clusters and trajectories. PROSPERO REGISTRATION: CRD42020194258.

Development and Psychometric Validation of the Nursing Self-Efficacy Scale for Managing Cancer Treatment-Induced Cardiotoxicity: An Exploratory Mixed-Method Study.

OBJECTIVE: Assessing nursing self-efficacy could be strategic to sustain nursing competence. This study aimed to develop and validate the nursing self-efficacy scale for managing cancer treatment-induced cardiotoxicity (NSS-CTC). DATA SOURCES: An exploratory mixed-method study was performed by including two main phases. The first comprised the developmental tasks to generate the initial pool of items, including a literature review and a consensus meeting based on a nominal group technique. The second phase initially involved an external panel of experts in assessing the content validity of the novel scale, followed by a cross-sectional data collection to perform exploratory factor analysis by employing a multicenter and convenience sampling approach. The most plausible psychometric structure derived from the exploratory factor analysis was tested with a confirmatory factor analysis using a second data collection round on another sample enrolled with a multicenter and convenience sampling approach. Internal consistency was assessed using Cronbach's alfa. CONCLUSION: The NSS-CTS is a novel 15-item self-report measure for assessing nurse self-efficacy in dealing with cancer treatment-related cardiotoxicity. Its two plausible domains were labeled knowledge-related self-efficacy (Cronbach's α = 0.924) and practice-related self-efficacy (Cronbach's α = 0.937); the factor analyses in both samples showed adequate fit to sample statistics. Future studies are necessary to corroborate its construct validity and assess its measurement invariance across various country contexts. IMPLICATIONS FOR NURSING PRACTICE: Assessing nursing self-efficacy for managing cancer treatment-induced cardiotoxicity is a promising approach for identifying educational gaps and promoting nursing competency in this particular area of cancer care.

A Systematic Review of Systematic Reviews and Pooled Meta-Analysis on Psychosocial Interventions for Improving Cancer-Related Fatigue.

OBJECTIVES: Psychosocial care is essential in oncology to address specific cancer-related fatigue dimensions. Psychosocial interventions have been defined as nonpharmacologic interventions that address psychological or social factors rather than biological mechanisms and might positively influence symptoms, quality of life, and social functioning. This systematic review of systematic reviews pooled the effects from the recent systematic reviews describing the relationships between psychosocial interventions and fatigue in adult patients with cancer, providing an overall estimate of their effect on cancer-related fatigue. DATA SOURCES: PubMed, CINAHL, Cochrane Database of Systematic Reviews, PEDro, and PsycINFO were searched from 2010 through 2022. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The risk of bias in eligible systematic reviews was assessed using the Cochrane Collaboration's risk of bias tool (ROBIS). PROTOCOL REGISTRATION: Prospero (CRD42020194254). CONCLUSION: Psychosocial interventions are a promising option to reduce cancer-related fatigue, albeit with short-term effects. However, further research is needed to evaluate the efficacy of specific interventions within population clusters and to examine their long-term effectiveness. IMPLICATIONS FOR NURSING PRACTICE: Nurses play a crucial role in promoting psychosocial dimensions in cancer care. This study provides clinicians and researchers with up-to-date information on the efficacy of psychosocial interventions for reducing cancer-related fatigue overcoming the limits of several separate systematic reviews. The results might guide future research and facilitate the translation of the evidence into clinical practice, acknowledging that a gap between the unmet needs of patients with cancer and appropriate health care services still needs addressing.

Trajectories of Health-Related Quality of Life, Health Literacy, and Self-Efficacy in Curatively-Treated Patients with Esophageal Cancer: A Longitudinal Single-Center Study in Italy.

This prospective longitudinal study aimed to describe the trajectories of HRQoL, health literacy, and self-efficacy in patients with esophageal cancer, which have been thus far poorly described. Data were collected at baseline (preoperative phase) and in the postoperative period (two weeks, and one, two, and three months after esophagectomy). The study hypothesis was that health literacy and self-efficacy might predict better health status and quality of life over time. Forty-five patients were enrolled between 2018 and 2019. HRQoL, health literacy, and self-efficacy were assessed using validated scales. The ability to analyze information to exert greater control over life events critically (critical health literacy) (η2 p = 0.660) and the individual's confidence in dealing with challenging tasks (self-efficacy) (η2 p = 0.501) strongly predicted the scores of general health status over time. Overall, the functional status improved at 3 months after surgery, and this trend paralleled the decline of cancer-specific and surgery-related symptoms. In conclusion, researchers and clinicians should pay greater attention to optimizing baseline health literacy and self-efficacy levels. Future educational and motivational interventions should be further tested and possibly integrated into the prehabilitation programs.

[Italian Version of Chemotherapy-induced Alopecia Distress Scale (I-CADS): linguistic cultural adaptation, content validity and psychometrics assessment.] / Versione italiana della Chemotherapy-induced Alopecia Distress Scale (I-CADS): adattamento linguistico culturale, validità di contenuto e valutazione delle proprietà psicometriche.

Distress could be often experienced by breast cancer patients with chemotherapy-induced alopecia. Those distress assessment is strategic to deliver care in a tailored way, enhancing the overall wellbeing. So far, those distress is measurable by the Chemotherapy-induced Alopecia Distress Scale (CADS), which is not yet available in Italian, due to there are no validation studies on this topic. For this reason, the aim of this study was to validate and adapt Chemotherapy-induced Alopecia Distress Scale within the Italian context (I-CADS). Specifically, the following validations were assessed: cultural-linguistic, qualitative and quantitative content validity, psychometrics and internal consistency (reliability) assessments. To answer to the specific aims, the study design was multiphase: 1) firstly, authors provided a linguistic and cultural validation; 2) then a panel of expert (n=16) was involved to assess qualitative and quantitative content validity, using CVR, I-CVIs, S-CVI; finally 3) a cross-sectional sampling was used to establish the psychometric proprieties and the internal consistency. In the third phase the data were analyzed through different exploratory factorial analysis models, using Maximum Likelihood Robust estimator and Geomin factor rotation. I-CADS has 16 items, measuring three domains, which are self-perception, emotivism and social engaging. The items internal consistency (α Cronbach was always major of 0.93) within their domain shows a good reliability. I-CADS could be routinely used to support clinical decision-making, due to it is useful to intercept distress related to low self-perception, emotivism and social engaging. Moreover, I-CAD clear psychometric structure could facilitate its usefulness in those researches where it is needed to measure distress amongst breast cancer patients with chemotherapy-induced alopecia.