The relevance of the contribution of psychoneuroendocrinoimmunology and psychology of reasoning and decision making to nursing science: A discursive paper.

AIM: Patients' death or adverse events appear to be associated with poor healthcare decision-making. This might be due to an inability to have an adequate representation of the problem or of the connections among problem-related elements. Changing how a problem is formulated can reduce biases in clinical reasoning. The purpose of this article is to explore the possible contributions of psychoneuroendocrinoimmunology (PNEI) and psychology of reasoning and decision-making (PRDM) to support a new nursing theoretical frame. DESIGN: Discursive paper. METHOD: This article discusses the main assumptions about nursing and nurses' ability to face patient's problems, suggesting a new approach that integrates knowledge from PNEI and PRDM. While PNEI explains the complexity of systems, highlighting the importance of systems connections in affecting health, PRDM underlines the importance of the informative context in creating a mental representation of the problem. Furthermore, PRDM suggests the need to pay attention to information that is not immediately explicit and its connections. CONCLUSION: Nursing recognizes the patient-nurse relationship as the axiom that governs care. The integration of PNEI and PRDM in nursing theoretics allows the expansion of the axiom by providing essential elements to read a new type of relationship: the relationship among information. PNEI explains the relationships between biological systems and the psyche and between the whole individual and the environment; PRDM provides tools for the nurse's analytical thinking system to correctly process information and its connections. IMPACT ON NURSING PRACTICE: A theoretical renewal is mandatory to improve nursing reasoning and nursing priority identification. Integrating PNEI and PRDM into nursing theoretics will modify the way professionals approach patients, reducing cognitive biases and medical errors. NO PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public involvement in the design or writing of this discursive article.

Support for Chronic Pain Management for Breast Cancer Survivors Through Novel Digital Health Ecosystems: Pilot Usability Study of the PainRELife Mobile App.

BACKGROUND: Chronic pain is one of the most common and critical long-term effects of breast cancer. Digital health technologies enhance the management of chronic pain by monitoring physical and psychological health status and supporting pain self-management and patient treatment decisions throughout the clinical pathway. OBJECTIVE: This pilot study aims to evaluate patients' experiences, including usability, with a novel digital integrated health ecosystem for chronic pain named PainRELife. The sample included patients with breast cancer during survivorship. The PainRELife ecosystem comprises a cloud technology platform interconnected with electronic health records and patients' devices to gather integrated health care data. METHODS: We enrolled 25 patients with breast cancer (mean age 47.12 years) experiencing pain. They were instructed to use the PainRELife mobile app for 3 months consecutively. The Mobile Application Rating Scale (MARS) was used to evaluate usability. Furthermore, pain self-efficacy and participation in treatment decisions were evaluated. The study received ethical approval (R1597/21-IEO 1701) from the Ethical Committee of the European Institute of Oncology. RESULTS: The MARS subscale scores were medium to high (range: 3.31-4.18), and the total app quality score was 3.90. Patients with breast cancer reported reduced pain intensity at 3 months, from a mean of 5 at T0 to a mean of 3.72 at T2 (P=.04). The total number of times the app was accessed was positively correlated with pain intensity at 3 months (P=.03). The engagement (P=.03), information (P=.04), and subjective quality (P=.007) subscales were positively correlated with shared decision-making. Furthermore, participants with a lower pain self-efficacy at T2 (mean 40.83) used the mobile app more than participants with a higher pain self-efficacy (mean 48.46; P=.057). CONCLUSIONS: The data collected in this study highlight that digital health technologies, when developed using a patient-driven approach, might be valuable tools for increasing participation in clinical care by patients with breast cancer, permitting them to achieve a series of key clinical outcomes and improving quality of life. Digital integrated health ecosystems might be important tools for improving ongoing monitoring of physical status, psychological burden, and socioeconomic issues during the cancer survivorship trajectory. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/41216.

Balancing benefits and risks in lung cancer therapies: patient preferences for lung cancer treatment alternatives.

Background: In the treatment of Non-Small Cell Lung Cancer (NSCLC) the combination of Immuno- Oncotherapy (IO) and chemotherapy (CT) has been found to be superior to IO or CT alone for patients' survival. Patients and clinicians are confronted with a preference sensitive choice between a more aggressive treatment with a greater negative effect on quality of life versus alternatives that are less effective but have fewer side effects. Objectives: The aims of this study were to: (a) quantify patients' preferences for relevant attributes related to Immuno-Oncotherapy treatment alternatives, and (b) evaluate the maximum acceptable risk (MAR)/Minimum acceptable benefit (MAB) that patients would accept for treatment alternatives. Methods: An online preference survey using discrete-choice experiment (DCE) was completed by NSCLC patients from two hospitals in Italy and Belgium. The survey asked patients' preferences for five patient- relevant treatment attributes. The DCE was developed using a Bayesian D-efficient design. DCE analyses were performed using mixed logit models. Information regarding patient demographics, health literacy, locus of control, and quality of life was also collected. Results: 307 patients (158 Italian, 149 Belgian), stage I to IV, completed the survey. Patients preferred treatments with a higher 5-year survival chance as the most important attribute over all the other attributes. Preference heterogeneity for the attribute weights depended on health literacy, patients' age and locus of control. Patients were willing to accept a substantially increased risks of developing side effects in exchange for the slightest increase (1%) in the chance of surviving at least 5 years from the diagnosis of cancer. Similarly, patients were willing to accept a switch in the mode of administration or complete loss of hair to obtain an increase in survival. Conclusion: In this study, the proportion of respondents who systematically preferred survival over all other treatment attributes was particularly high. Age, objective health literacy and locus of control accounted for heterogeneity in patients' preferences. Evidence on how NSCLC patients trade between survival and other NSCLC attributes can support regulators and other stakeholders on assessing clinical trial evidence and protocols, based on patients' conditions and socio-demographic parameters.

Usability Testing of a New Digital Integrated Health Ecosystem (PainRELife) for the Clinical Management of Chronic Pain in Patients With Early Breast Cancer: Protocol for a Pilot Study.

BACKGROUND: Chronic pain (CP) and its management are critical issues in the care pathway of patients with breast cancer. Considering the complexity of CP experience in cancer, the international scientific community has advocated identifying cutting-edge approaches for CP management. Recent advances in the field of health technology enable the adoption of a novel approach to care management by developing integrated ecosystems and mobile health apps. OBJECTIVE: The primary end point of this pilot study is to evaluate patients' usability experience at 3 months of a new digital and integrated technological ecosystem, PainRELife, for CP in a sample of patients with breast cancer. The PainRELife ecosystem is composed of 3 main technological assets integrated into a single digital ecosystem: Fast Healthcare Interoperability Resources-based cloud platform (Nu platform) that enables care pathway definition and data collection; a big data infrastructure connected to the Fast Healthcare Interoperability Resources server that analyzes data and implements dynamic dashboards for aggregate data visualization; and an ecosystem of personalized applications for patient-reported outcomes collection, digital delivery of interventions and tailored information, and decision support of patients and caregivers (PainRELife app). METHODS: This is an observational, prospective pilot study. Twenty patients with early breast cancer and chronic pain will be enrolled at the European Institute of Oncology at the Division of Medical Senology and the Division of Pain Therapy and Palliative Care. Each patient will use the PainRELife mobile app for 3 months, during which data extracted from the questionnaires will be sent to the Nu Platform that health care professionals will manage. This pilot study is nested in a large-scale project named "PainRELife," which aims to develop a cloud technology platform to interoperate with institutional systems and patients' devices to collect integrated health care data. The study received approval from the Ethical Committee of the European Cancer Institute in December 2021 (number R1597/21-IEO 1701). RESULTS: The recruitment process started in May 2022 and ended in October 2022. CONCLUSIONS: The new integrated technological ecosystems might be considered an encouraging affordance to enhance a patient-centered approach to managing patients with cancer. This pilot study will inform about which features the health technological ecosystems should have to be used by cancer patients to manage CP. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41216.

The EU-funded I3LUNG Project: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy.

Although immunotherapy (IO) has changed the paradigm for the treatment of patients with advanced non-small cell lung cancers (aNSCLC), only around 30% to 50% of treated patients experience a long-term benefit from IO. Furthermore, the identification of the 30 to 50% of patients who respond remains a major challenge, as programmed Death-Ligand 1 (PD-L1) is currently the only biomarker used to predict the outcome of IO in NSCLC patients despite its limited efficacy. Considering the dynamic complexity of the immune system-tumor microenvironment (TME) and its interaction with the host's and patient's behavior, it is unlikely that a single biomarker will accurately predict a patient's outcomes. In this scenario, Artificial Intelligence (AI) and Machine Learning (ML) are becoming essential to the development of powerful decision-making tools that are able to deal with this high-complexity and provide individualized predictions to better match treatments to individual patients and thus improve patient outcomes and reduce the economic burden of aNSCLC on healthcare systems. I3LUNG is an international, multicenter, retrospective and prospective, observational study of patients with aNSCLC treated with IO, entirely funded by European Union (EU) under the Horizon 2020 (H2020) program. Using AI-based tools, the aim of this study is to promote individualized treatment in aNSCLC, with the goals of improving survival and quality of life, minimizing or preventing undue toxicity and promoting efficient resource allocation. The final objective of the project is the construction of a novel, integrated, AI-assisted data storage and elaboration platform to guide IO administration in aNSCLC, ensuring easy access and cost-effective use by healthcare providers and patients.

Evidence for Choosing Qigong as an Integrated Intervention in Cancer Care: An Umbrella Review.

Cancer is the second leading cause of noncommunicable disease death, with an increasing incidence. Qigong practice can moderate non-intrinsic, modifiable risk factors that act on the stress response using physical movements, breathing, and focused attention. The purpose of this umbrella review is to provide a concise summary to facilitate an evidence-based decision to integrate Qigong into cancer patients' care. Relevant systematic reviews and meta-analyses were identified and retrieved from the JBI database, Cochrane Library, PubMed, Embase, and CINAHL. Of all of the studies assessed, none found evidence of a risk to cancer patients, indicating that Qigong is a safe practice that can be used even by frail patients. The overall quality of life, cancer-related fatigue, and cognitive impairment were improved by Qigong. Different Qigong programs have different impacts on sleep quality and gastrointestinal problems, suggesting that longer practice sessions are required to achieve improvements. To maintain Qigong's effectiveness, an ordinary practice is essential, or such effectiveness will wear off. The use of biological markers in efficacy assessments needs to be more systematically studied. However, positive WBC, RBC, and CRP trends in Qigong practitioners are evident. Higher-quality clinical studies are necessary to measure variables more closely related to Qigong functioning and consider cancer's multifactorial nature.

Ethical issues in oncology practice: a qualitative study of stakeholders' experiences and expectations.

BACKGROUND: Clinical Ethics Support Services (CESS) have been established to support healthcare professionals in addressing ethically sensitive issues in clinical practice and, in many countries, they are under development. In the context of growing CESS, exploring how healthcare professionals experience and address clinical ethics issues in their daily practice represents a fundamental step to understand their potential needs. This is even more relevant in the context of extremely sensitive diseases, such as cancer. On this basis, we carried out a qualitative study conducting in-depth semi-structured interviews with stakeholders of a major comprehensive cancer centre in Italy, with the twofold aim of investigating what ethical issues arise in the context of clinical oncology and how they are addressed, as well as stakeholders' expectations about a potential CESS to be implemented within the Institution. METHODS: The study was conducted within the theoretical framework of Grounded Theory. Participants were healthcare professionals and other key stakeholders working within the cancer centre. The semi-structured interview aimed at exploring common ethical aspects of oncology, investigating stakeholders' professional experience in dealing with clinical ethics issues, their expectations and requests regarding ethics support services. Transcripts of the interviews were coded and analysed according to the principles of Grounded Theory. RESULTS: Twenty-one stakeholders were interviewed. Our analysis showed a wide consensus on the identification of ethically relevant issues, above all those concerning communication, end-of-life, and resource allocation. The absence of institutional tools or strategies to address and manage ethical issues at the patient bedside emerged, and this is reflected in the widespread request for their development in the future. The ideal support service should be fast and flexible in order to adapt to different needs and clinical cases. CONCLUSIONS: The interviewees showed a limited degree of 'ethical awareness': despite having reported many issues in clinical practice, they could hardly identify and describe the ethical aspects, while  complaining about a lack of ethical resources in their management. To build a truly effective support service, it therefore seems appropriate to take such context into consideration and address the emerged needs. Ethical sensitivity seems to be key and it becomes even more relevant in critical clinical areas, such as the therapeutic pathways of terminally ill patients.

A meta-analysis on heart rate variability biofeedback and depressive symptoms.

Heart rate variability biofeedback (HRVB) has been used for a number of years to treat depressive symptoms, a common mental health issue, which is often comorbid with other psychopathological and medical conditions. The aim of the present meta-analysis is to test whether and to what extent HRVB is effective in reducing depressive symptoms in adult patients. We conducted a literature search on Pubmed, ProQuest, Ovid PsycInfo, and Embase up to October 2020, and identified 721 studies. Fourteen studies were included in the meta-analysis. Three meta-regressions were also performed to further test whether publication year, the questionnaire used to assess depressive symptoms, or the interval of time between T0 and T1 moderated the effect of HRVB. Overall, we analysed 14 RCTs with a total of 794 participants. The random effect analysis yielded a medium mean effect size g = 0.38 [95% CI = 0.16, 0.60; 95% PI = - 0.19, 0.96], z = 3.44, p = 0.0006. The total heterogeneity was significant, QT = 23.49, p = 0.03, I2 = 45%, which suggested a moderate variance among the included studies. The year of publication (χ2(1) = 4.08, p = 0.04) and the questionnaire used to assess symptoms (χ2(4) = 12.65, p = 0.01) significantly moderated the effect of the interventions and reduced heterogeneity. Overall, results showed that HRVB improves depressive symptoms in several psychophysiological conditions in adult samples and should be considered as a valid technique to increase psychological well-being.

An Internet-Based Intervention to Alleviate Stress During Social Isolation With Guided Relaxation and Meditation: Protocol for a Randomized Controlled Trial.

BACKGROUND: Psychophysiological stress and decreased well-being are relevant issues during prolonged social isolation periods. Relaxation practices may represent helpful exercises to cope with anxiety and stressful sensations. OBJECTIVE: The aim of this research protocol is to test whether remote relaxation practices such as natural sounds, deep respiration, and body scan meditation promote relaxation and improved emotional state and reduce psychomotor activation and the preoccupation related to the coronavirus disease (COVID-19) pandemic. METHODS: The study population will consist of 3 experimental groups that will randomly receive one of 3 internet-based audio clips containing a single session of guided breathing exercise, guided body scan exercise, or natural sounds. The participants will listen to the fully automated audio clip for 7 minutes and complete pre-post self-assessment scales on their perceived relaxation, psychomotor activation, level of worry associated with COVID-19, and emotional state. At the end of the session, the participants will also be asked to provide qualitative reports on their subjective experiences. RESULTS: Analyses will be performed to test the differences in the efficacy of the different audio clips in an internet-based intervention on 252 participants (84 per group), investigating whether natural sounds or remote guided practices such as deep respiration and body scan meditation positively enhance the participants' perceived psychological state. CONCLUSIONS: The study will provide information on if and to what extent guided practices can help in reducing psychological side effects related to social isolation during the COVID-19 pandemic. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/19236.

Distress and Psychosocial Needs in Patients Accessing a Cancer Day Surgery Division: Implications for Clinical Decision Making.

Introduction: The Distress Thermometer (DT) was built and validated for screening cancer patients for distress, as suggested by the National Comprehensive Cancer Network. The current work was designed to measure the rates of distress in a sample of patients being hospitalized in a multidisciplinary outpatient surgery clinic. OBJECTIVE: To measure the rates of distress in a sample of patients referring to a multidisciplinary day surgery division in a comprehensive cancer center based in Northern Italy. Methods: A total of 177 patients were asked to fill in the (DT) before surgery. Results: Out of 177 patients, 154 (87%) patients completed the DT. While 13% of the patients indicated a total absence of distress, more than half of the sample declared a moderate or high distress. A total of 55% of patients presented at least three difficulties in the Problem List Checklist. Distress was not correlated with age or other medical and clinical variables. Number of emotional problems was the best predictor of distress at admission (ß = 0.655, p = 0.000). Conclusion: Screening for distress in a day surgery multidisciplinary oncology division is feasible and a relevant percentage of patients can be identified as clinically distressed. Outcomes also highlight the impact of age and precise physical and psycho-social signs as prognostic indicators of clinically significant distress. Measurement of distress and associated problems list represent the preliminary endpoint toward adequate recommendations that contribute to taking care of distress in cancer patients in cost-effective clinical setting.

Clinical Trials, Data Protection and Patient Empowerment in the Era of the New EU Regulations.

Cancer clinical trials and, in general, cancer clinical research by definition need a multi-modality approach. It is not enough to discover and register new drugs. To get cancer under control requires us to perform complex clinical studies that integrate drugs, companion diagnostics, new or improved surgical procedures and new radiotherapy approaches as well as, most importantly, to integrate all available information. This includes biological material and, of increasing importance, large amounts of data using big data technologies. To personalise treatment, genetic data are more and more frequently used. Therefore, the general approach is holistic. Legislators, on the other hand, work in a silo mentality; the needs of clinical research are poorly understood, and legislation focuses on either health care or the commercialisation of a product, and not on clinical research. In the last 2 years the EU has drafted several major regulations touching on clinical trials, in vitro diagnostics, medical devices and data protection, all of which will impact clinical research, although the silo mentality makes the overall framework inconsistent and potentially highly damaging to the EU's capacity to make rapid progress in the field of personalised medicine.

The relation of post-work ruminative thinking with eating behaviour.

Inability to unwind about work during leisure time has been associated with a number of negative health outcomes. This study was concerned with a possible behavioural pathway between unwinding and disease and examined the relationship between work-related rumination and food choice. Work-related rumination is arguably a core to understanding the 'unwinding process', and food choice is a well-established indicator of nutritional health. Two hundred and sixty-eight full-time workers from a range of white-collar occupations completed a self-report measure of ruminative thinking about work and an eating behaviour questionnaire. Three types of ruminative thinking were identified by factor analysis and labelled affective rumination, problem-solving pondering and detachment. In terms of food choice, high-relative to low-affective ruminators reported eating more unhealthy foods, and low detachers reported eating less cooked meals and more processed foods compared to high detachers. Problem-solving pondering was not associated with food choice, and none of the factors were associated with healthy food choice. It was concluded that failure to unwind from work is not necessarily related to unhealthy food choices. What appears to be the crucial factor is the type of perseverative thinking that people engage in post-work. Limitations and future directions are discussed.