Sexual satisfaction and its predictors in patients with advanced cancer and their family caregivers in six European countries: Baseline data from the DIAdIC study.

OBJECTIVE: To identify predictors of sexual satisfaction in patients with advanced cancer and their family caregivers. METHODS: Cross-sectional study using baseline survey data from a randomized controlled trial in six European countries. Patients with advanced cancer and their family caregiver completed measures on sexual satisfaction (one item from Functional Assessment of Cancer Therapy - General questionnaire for patients and Caregiver Quality of Life Index-Cancer scale for family caregivers) and health-related characteristics. Multivariable linear regressions were performed for all predictors (identified based on literature) with sexual satisfaction as dependent variable. RESULTS: The sample comprised 431 patient-family caregiver dyads. Patients with prostate or gynecological cancer reported lower sexual satisfaction (respectively B = -0.267 95% CI: -1.674, -0.594 and B = -0.196, 95% CI -2.103, -0.452). Higher emotional (B = 0.278, 95% CI 0.024, 0.057) physical (B = 0.305, 95% CI 0.012, 0.025) and social functioning (B = 0.151, 95% CI 0.001, 0.013), global health (B = 0.356, 95% CI 0.007, 0.013) and social wellbeing (B = 0.161, 95% CI 0.013, 0.082) among patients were associated with higher sexual satisfaction. Among family caregivers, sexual satisfaction was lower with increased age (B = -0.142, 95% CI -0.022, -0.004). Higher emotional functioning (B = 0.027, 95% CI 0.011, 0.043) and quality of life (B = 0.165, 95% CI -0.165, 0.716) were associated with higher sexual satisfaction in family caregivers. CONCLUSIONS: The results underscore that sexual wellbeing of patients and family caregivers is related to health related factors in physical, emotional, and social domains. Patients and family caregivers could benefit from a dyadic approach to address sexual wellbeing.

Defining a balance by compromising with fear: A grounded theory study on returning to eating after a total gastrectomy.

OBJECTIVES: Gastric cancer patients undergoing total gastrectomy face nutrition-related complications and worsening quality of life after surgery. In this context, gastrectomized cancer patients are required to cope with new conditions. Little is known about their accommodating feeding to the new life condition as a negotiated process among stakeholders in real contexts. This study aimed to investigate the shaping of this process as influenced by the perspectives of patients, health-care professionals (HPs), and caregivers (CGs). METHODS: A constructivist grounded theory study, through semi-structured interviews and interpretative coding, was designed to answer the following research question: "what is the process of returning to eating and feeding after a gastrectomy?" RESULTS: The final sample included 18 participants. "Defining a balance by compromising with fear" is the core category explaining returning to eating as a process negotiated by all actors involved, with patients trying to find a feeding balance through a multi-layer compromise: with the information received by HPs, the proprioception drastically altered by gastric resection, new dietary habits to accept, and complex and often minimized conviviality. This process involves 4 main conceptual phases: relying on the doctors' advice, perceptive realignment, rearranging food intake, and food-regulated social interaction. Those categories are also shaped by the fear of being unwell from eating and the constant fear of tumor relapse. SIGNIFICANCE OF RESULTS: Multiple actors can meet patients' and their CGs' nutritional, care, and psychosocial needs. A multidisciplinary approach involving nutritionists, psychologists, occupational therapists, social workers, and anthropologists can be key to effectively managing these patients' survivorship care. We suggest training all the professionals on the first level of nutritional counseling.

Systematic translation and adaptation of the FOCUS program, a USA-based supportive intervention for persons with cancer and their family caregivers, for use in six European countries.

PURPOSE: Having advanced cancer presents many challenges for patients and family caregivers. The FOCUS program is a psychoeducational nurse-led intervention, developed in the USA, to support dyads of patients with cancer and their family caregivers to live with the illness. The program includes a conversation manual and information resources for dyads. We aimed to develop a version of the program for dyads facing advanced cancer in six European countries. METHOD: The Participatory and Iterative Process Framework for Language Adaptation (PIPFLA) was used to guide the translation of the program to the local contexts of Belgium, Denmark, Ireland, Italy, the Netherlands, and the UK. In several rounds, potential program users (e.g., nurses, clinicians, patients, family caregivers) and researchers from all six countries reviewed program materials and advised on adaptations. RESULTS: The PIPFLA process resulted in one European version of the program in different languages (FOCUS +). The FOCUS + conversation manual is uniform across all countries. The main adaptations included additional attention to both family caregiver and patient needs; more emphasis on self-management, advance care planning, and shared responsibilities; discussing the dyad's outlook rather than optimism; addressing the role of nurses as educational rather than therapeutic; and more suggestions to refer dyads to health care professionals for specific care needs. The information resources for dyads were adapted to fit with local contexts. CONCLUSION: The PIPFLA methodology is an efficient and effective framework to thoroughly translate and culturally adapt a complex USA-based program for use in six European countries in collaboration with end users.

How parents and health professionals experience prematurity in an Italian neonatal intensive care: A grounded theory study.

PURPOSE: The aim of this study was to explore prematurity as a psycho-social process from the point of view of both parents and healthcare professionals. DESIGN AND METHODS: We conducted a Grounded Theory study through semi-structured interviews. Participants were from an Italian Neonatal Intensive Care Unit, including parents of premature children, and health professionals. Interviews were analyzed according to Grounded Theory coding strategies, to hypothesize a theoretical model. RESULTS: On one side, behaviors, emotions, and feelings of parental couples; on the other one, the activities and reactions of professionals have been interpreted in a four-phase negotiated process: 1) the initial breakup; 2) the floating family; 3) the event processing; 4) the reconstruction of a new family. CONCLUSIONS: Managing prematurity is a negotiated process which could be better managed through a family-centered approach as fundamental in neonatal and pediatric services. Being open in listening, coherent in the given answers, and knowing the entire process and story of being suddenly parents of a premature child can make the difference in the future definition of a new family. PRACTICE IMPLICATIONS: Perinatal care would benefit from the following suggested practical implications: i) reducing feelings of separation and solitude by integrating diverse professionals around the family systems; ii) expediting prematurity-related changes through peer-support during hospitalization and attention to rooms' organization; iii) enhancing information exchange between all professionals involved in the care of dyads/parents and new-borns, starting since the pregnancy and continuing after the child's birth by implementing multidisciplinary meetings or appropriate care pathways.

"Challenging Professional Boundaries": A Grounded Theory Study of Health Professionals' First Experiences of End-of-Life Care in Hospital.

Little is known about health professionals first experiences of End-of-Life care in hospital. This study aims to understand the psycho-social process that occurs when hospital-based health professionals engage in caring for a dying patient for the first time. We conducted a Grounded Theory study, with 19 health professionals. Challenging professional boundaries is the core category which explains the overall process. The theoretical model we conceptualized evidenced three phases: 1) building a relationship between patient/family and professionals, 2) the disrupting impact and 3) the reaction phase. Our analysis highlighted the initial strong impact of this experience, which brought professionals to perceive emotional suffering and feelings of inadequacy. The new aspect our grounded theory revealed is that all the categories are pertinent to all the professionals involved, therefore they explain important aspects of interprofessional collaboration in End-of-Life care.

"Achieve the best while rushing against time": A grounded theory study on caring for low-income immigrant cancer patients at end of life.

BACKGROUND: Between 2000 and 2020, Europe experienced an annual net arrival of approximately 1.6 million immigrants per year. While having lower mortality rates, in the setting of severe diseases, immigrants bear a greater cancer-related burden due to linguistic and cultural barriers and socio-economic conditions. Professionals face a two-fold task: managing clinical conditions while considering the social, economic, cultural, and spiritual sphere of patients and their families. In this regard, little is known about the care provision to low-income immigrant cancer patients in real contexts. AIM: To investigate the perspective of professionals, family members, and stakeholders on the caring process of low-income immigrant cancer patients at the end of life. DESIGN: A Constructivist Grounded Theory study. SETTING/PARTICIPANTS: The study, conducted at a Hospital in Northern Italy, involved 27 participants among health professionals, family caregivers, and other stakeholders who had recently accompanied immigrant cancer patients in their terminal phase of illness. RESULTS: Findings evidenced that professionals feel they were not adequately trained to cope with immigrant cancer patients, nonetheless, they were highly committed in providing the best care they could, rushing against the (short) time the patients have left. Analyses evidenced four main categories: "providing and receiving hospitality," "understanding each other," "addressing diversity," and "around the patient," which we conceptualized under the core category "Achieve the best while rushing against time." CONCLUSIONS: The model reveals the activation of empathic and compassionate behavior by professionals. It evidences the need for empowering professionals with cultural competencies by employing interpreters and specific training programs.

Providing dignity therapy to patients with advanced cancer: a feasibility study within the setting of a hospital palliative care unit.

BACKGROUND: Dignity is a basic principle of palliative care and is intrinsic in the daily practice of professionals assisting individuals with incurable diseases. Dignity Therapy (DT) is a short-term intervention aimed at improving the sense of purpose, meaning and self-worth and at reducing the existential distress of patients facing advanced illness. Few studies have examined how DT works in countries of non-Anglo Saxon culture and in different real-life settings. Moreover, most studies do not provide detailed information on how DT is conducted, limiting a reliable assessment of DT protocol application and of its evaluation procedure. The aim of this study was to assess the feasibility and acceptability of a nurse-led DT intervention in advanced cancer patients receiving palliative care. METHOD: This is a mixed-method study using before and after evaluation and semistructured interviews. Cancer patients referred to a hospital palliative care unit were recruited and provided with DT. The duration of sessions, and timeframes concerning each step of the study, were recorded, and descriptive statistical analyses were performed. The patients' dignity-related distress and feedback toward the intervention were assessed through the Patient Dignity Inventory and the Dignity Therapy Patient Feedback Questionnaire, respectively. Three nurses were interviewed on their experience in delivering the intervention, and the data were analyzed qualitatively. RESULTS: A total of 37/50 patients were enrolled (74.0%), of whom 28 (75.7%) completed the assessment. In 76.7% of cases, patients completed the intervention in the time limit scheduled in the study. No statistically significant reduction in the Patient Dignity Inventory scores was observed at the end of the intervention; most patients found DT to be helpful and satisfactory. Building opportunities for personal growth and providing holistic care emerged among the facilitators to DT implementation. Nurses also highlighted too great of a time commitment and a difficult collaboration with ward colleagues among the barriers. CONCLUSIONS: Our findings strongly support the acceptability, but only partially support the feasibility, of nurse-led DT in advanced cancer patients in a hospital setting. Further research is needed on how to transfer the potential benefits of DT into clinical practice. TRIAL REGISTRATION: Retrospectively registered on ClinicalTrial.gov NCT04738305 .

Effectiveness of a nurse-delivered (FOCUS+) and a web-based (iFOCUS) psychoeducational intervention for people with advanced cancer and their family caregivers (DIAdIC): study protocol for an international randomized controlled trial.

BACKGROUND: Worldwide, millions of people with advanced cancer and their family caregivers are experiencing physical and psychological distress. Psychosocial support and education can reduce distress and prevent avoidable healthcare resource use. To date, we lack knowledge from large-scale studies on which interventions generate positive outcomes for people with cancer and their informal caregivers' quality of life. This protocol describes the DIAdIC study that will evaluate the effectiveness of two psychosocial and educational interventions aimed at improving patient-family caregiver dyads' emotional functioning and self-efficacy. METHODS: We will conduct an international multicenter three-arm randomized controlled trial in Belgium, Denmark, Ireland, Italy, The Netherlands, and the United Kingdom. In each country, 156 dyads (936 in total) of people with advanced cancer and their family caregiver will be randomized to one of the study arms: 1) a nurse-led face-to-face intervention (FOCUS+), 2) a web-based intervention (iFOCUS) or 3) a control group (care as usual). The two interventions offer tailored psychoeducational support for patient-family caregiver dyads. The nurse-led face-to-face intervention consists of two home visits and one online video session and the web-based intervention is completed independently by the patient-family caregiver dyad in four online sessions. The interventions are based on the FOCUS intervention, developed in the USA, that addresses five core components: family involvement, optimistic outlook, coping effectiveness, uncertainty reduction, and symptom management. The FOCUS intervention will be adapted to the European context. The primary outcomes are emotional functioning and self-efficacy of the patient and the family caregiver, respectively. The secondary outcomes are quality of life, benefits of illness, coping, dyadic communication, and ways of giving support of the patient and family caregiver. DISCUSSION: DIAdIC aims to develop cost-effective interventions that integrate principles of early palliative care into standard care. The cross-country setup in six European countries allows for comparison of effectiveness of the interventions in different healthcare systems across Europe. By focusing on empowerment of the person with cancer and their family caregiver, the results of this RCT can contribute to the search for cost-effective novel interventions that can relieve constraints on professional healthcare. TRIAL REGISTRATION: Registration on ClinicalTrials.gov on 12/11/2020, identifier NCT04626349 . DATE AND VERSION IDENTIFIER: 20211209_DIAdIC_Protocol_Article.

Health professionals and students' experiences of reflective writing in learning: A qualitative meta-synthesis.

BACKGROUND: Reflective writing provides an opportunity for health professionals and students to learn from their mistakes, successes, anxieties, and worries that otherwise would remain disjointed and worthless. This systematic review addresses the following question: "What are the experiences of health professionals and students in applying reflective writing during their education and training?" METHODS: We performed a systematic review and meta-synthesis of qualitative studies. Our search comprised six electronic databases: MedLine, Embase, Cinahl, PsycINFO, Eric, and Scopus. Our initial search produced 1237 titles, excluding duplicates that we removed. After title and abstract screening, 17 articles met the inclusion criteria. We identified descriptive themes and the conceptual elements explaining the health professionals' and students' experience using reflective writing during their academic and in-service training by performing a meta-synthesis. RESULTS: We identified four main categories (and related sub-categories) through the meta-synthesis: reflection and reflexivity, accomplishing learning potential, building a philosophical and empathic approach, and identifying reflective writing feasibility. We placed the main categories into an interpretative model which explains the users' experiences of reflective writing during their education and training. Reflective writing triggered reflection and reflexivity that allows, on the one hand, skills development, professional growth, and the ability to act on change; on the other hand, the acquisition of empathic attitudes and sensitivity towards one's own and others' emotions. Perceived barriers and impeding factors and facilitating ones, like timing and strategies for using reflective writing, were also identified. CONCLUSIONS: The use of this learning methodology is crucial today because of the recognition of the increasing complexity of healthcare contexts requiring professionals to learn advanced skills beyond their clinical ones. Implementing reflective writing-based courses and training in university curricula and clinical contexts can benefit human and professional development.

Health professionals learning qualitative research in their workplace: a focused ethnography.

BACKGROUND: The interest for qualitative research methodology has expanded beyond theoretical academic research on medical education, gathering interest from all healthcare professionals. Qualitative research has potentials in exploring the social, emotional, psychological aspects of care and in broadening professionals' scientific competencies. Nonetheless, qualitative research has still not been embraced within formal and academic curricula for future professionals, preventing newer generations from appreciating the value of its epistemological and methodological aspects and from using it in the development and implementation of clinical research. The purpose of this study was to comprehend the attitudes of health professionals learning and conducting qualitative studies within a practical training program developed in their workplace. METHODS: The present work consisted of a focused ethnography, including 14 professionals during their one-year attendance training on qualitative research methodology. Strategies used for collecting data included participant observations, field notes, semi-structured interviews, and a focus group. All the data were analyzed consistently with ethnographic indications. RESULTS: Analyses allowed us to evidence the educational, motivational, group-related and organizational factors influencing the attitudes and skill acquisition of healthcare professionals learning and conducting qualitative research within a practical training program developed in their workplace. Prior educational background was perceived as a sort of barrier. Nonetheless, the training boosted a change in attitude both in terms of appreciation of the research approach and trainees' emotional involvement with research participants. Doing a qualitative study in a multidisciplinary team raised in-group dynamics that hindered bringing the studies to conclusion. Trainees repeatedly lamented the difficulty in managing time to devote to research-related activities and questioned the feasibility of adopting this methodology for conducting research in their workplace. CONCLUSIONS: Continual education training on the methodological aspects and practical implications of qualitative research may foster a renewed attitude towards one's professional education, while making inter-professional relationship issues emerge. Nonetheless, broadening the perspectives of professionals on their clinical practice by means of learning qualitative methodology may have an evident quality improvement return. Strategies for future qualitative research methodology hands-on training addressed to health professionals in continuing education are proposed.

Undergoing head and neck cancer surgery: A grounded theory.

Surgery is the treatment of choice in most head and neck cancers. Very often, the surgery is radical with high impact on the psychosocial, functional and aesthetic fields. The aim of this study is to gain a deeper understanding of the patient's, clinician's and key informant's point of view when surgery is proposed, to improve the quality of pathways in terms of patients' practical, psychological and relational needs. We followed a Grounded Theory approach with semi-structured interviews. Seventeen participants (six patients, nine healthcare professionals and two volunteers) were interviewed immediately before surgery. The study generated a process of "persuading the patient of an obligation" as the core category. The other principal categories that emerged highlighted the patients' doubts and fears regarding the surgery consequences and, in parallel, strategies employed by the healthcare professionals to rebut hindering issues impeding surgery. In particular, healthcare professionals involved patients in an affiliation process through simplified communication to sustain the choice of surgery; the family plays a supportive role in this process. The interplay between the organisational process and patients' experience results in "I will let you convince me" at the end of the decision-making process, where the main aim was to save and be saved.

"I go into crisis when ": ethics of care and moral dilemmas in palliative care.

BACKGROUND: Recognising and knowing how to manage ethical issues and moral dilemmas can be considered an ethical skill. In this study, ethics of care is used as a theoretical framework and as a regulatory criterion in the relationship among healthcare professionals, patients with palliative care needs and family members. This study is a part of a larger project aimed at developing and implementing a training programme on "ethical communication" addressed to professionals caring for patients with palliative care needs. The aim of this study was comprehending whether and how the ethics of care informs the way healthcare professionals make sense of and handle ethical issues in palliative care. METHODS: Qualitative study employing a theoretically driven thematic analysis performed on semi-structured interviews. The research was conducted in a clinical cancer centre in northern Italy. Eligible participants were physicians and nurses from eleven hospital wards who assisted patients with chronic advanced disease daily and had previously attended a 4-h training on palliative care held by the hospital Palliative Care Unit. RESULTS: The researchers identified five themes: morality is providing global care; morality is knowing how to have a relationship with patients; morality is recognizing moral principles; moral dimension and communication; and moral dilemmas are individual conflicts. CONCLUSIONS: Ethics of care seems to emerge as a theoretical framework that includes the belief systems of healthcare professionals, especially those assisting patients with palliative care needs; moreover, it allows the values of both the patients and professionals to come to light through the relationship of care. Ethics of care is also appropriate as a framework for ethical training.

Is early integration of palliative care feasible and acceptable for advanced respiratory and gastrointestinal cancer patients? A phase 2 mixed-methods study.

BACKGROUND: There is evidence that early integration of palliative care improves quality of life, lowers spending and helps clarify preferences and goals for advanced cancer patients. Little is known about the feasibility and acceptability of early integration. AIM: Assessing feasibility of early integration of palliative care, and exploring concerns perceived and problems encountered by patients, relatives and oncologists. DESIGN: A phase 2 mixed-methods study ( ClinicalTrials.Gov :NCT02078700). METHODS: Oncologists of two outpatient clinics offered a specialised palliative care intervention integrated with standard oncological care to all consecutive newly diagnosed metastatic respiratory/gastrointestinal cancer patients. We interviewed samples of patients, relatives and oncologists to explore strengths and weaknesses of the intervention. RESULTS: The intervention was proposed to 44/54 eligible patients (81.5%), 40 (90.1%) accepted, 38 (95.0%) attended the first palliative care visit. The intervention was completed for 32 patients (80.0%). It did not start for three (7.5%) and was interrupted for three patients who refused (7.5%). The Palliative Care Unit performed 274 visits in 38 patients (median per patient 4.5), and 24 family meetings with relatives of 16 patients. All patients and most relatives referred to the usefulness of the intervention, specifically for symptoms management, information and support to strategies for coping. Oncologists highlighted their difficulties in informing patients on palliative intervention, sharing information and coordinating patient's care with the palliative care team. CONCLUSION: Early integration of palliative care in oncological setting seems feasible and well accepted by patients, relatives and, to a lesser extent, oncologists. Some difficulties emerged concerning patient information and inter-professional communication.

Validity, reliability and responsiveness to change of the Italian palliative care outcome scale: a multicenter study of advanced cancer patients.

BACKGROUND: There is an increasing requirement to assess outcomes, but few measures have been tested for advanced medical illness. We aimed to test the validity, reliability and responsiveness of the Palliative care Outcome Scale (POS), and to analyse predictors of change after the transition to palliative care. METHODS: Phase 1: multicentre, mixed method study comprising cognitive and qualitative interviews with patients and staff, cultural refinement and adaption. Phase 2: consecutive cancer patients on admission to 8 inpatient hospices and 7 home-based teams were asked to complete the POS, the EORTC QLQ-C15-PAL and the FACIT-Sp (T0), to assess internal consistency, convergent and divergent validity. After 6 days (T1) patients and staff completed the POS to assess responsiveness to change (T1-T0), and agreement between self-assessed POS and POS completed by the staff. Finally, we asked hospices an assessment 24-48 h after T1 to assess its reliability (test re-test analysis). RESULTS: Phase I: 209 completed POS questionnaires and 29 cognitive interviews were assessed, revisions made and one item substituted. Phase II: 295 consecutive patients admitted to 15 PCTs were approached, 175 (59.3 %) were eligible, and 150 (85.7 %) consented. Consent was limited by the severity of illness in 40 % patients. We found good convergent validity, with strong and moderate correlations (r ranged 0.5-0.8) between similar items from the POS, the QLQ-C15-PAL and the FACIT-Sp. As hypothesised, the physical function subscale of QLQ-C15-PAL was not correlated with any POS item (r ranged -0.16-0.02). We found acceptable to good test re-test reliability in both versions for 6 items. We found significant clinical improvements during the first week of palliative care in 7/10 items assessed-pain, other symptoms, patient and family anxiety, information, feeling at peace and wasted time. CONCLUSIONS: Both the patient self-assessed and professional POS versions are valid and with an acceptable internal consistency. POS detected significant clinical improvements during palliative care, at a time when patients are usually expected to deteriorate. These results suggest that there is room for substantial improvement in the management of patients with advanced disease, across all key domains-symptoms, psychological, information, social and spiritual.

'Less ticking the boxes, more providing support': A qualitative study on health professionals' concerns towards the Liverpool Care of the Dying Pathway.

BACKGROUND: Despite being widely used, research into the effectiveness of the Liverpool Care of the Dying Pathway (LCP) and associated cases of malpractice does not match dissemination. No study exists focusing on concerns voiced by professionals. AIM: To explore the views of professionals who, during the hospital implementation of the Italian version of the Liverpool Care of the Dying Pathway (LCP-I), voiced or showed concerns towards it. DESIGN: A qualitative study nested within the LCP-I randomized cluster trial, with semi-structured interviews analysed using thematic analysis. SETTING AND PARTICIPANTS: Six nurses and five physicians from six out of the eight hospital wards who completed the LCP-I implementation were interviewed. Eligibility criteria were having taken part in all steps of the LCP-I Programme, voiced or somehow shown concerns, or failed to fully engage with the implementation process. RESULTS: A total of 12 categories were identified, referring to four topics: the Implementation Programme, the LCP-I clinical documentation, the hospital environment and the educational and professional background of hospital healthcare staff. Issues raised by participants concerned both 'real' characteristics of the LCP-I and a misinterpretation of the LCP-I approach and clinical documentation. Furthermore, difficulties were reported which were not linked to the Programme but rather to end-of-life care. CONCLUSION: This study provides insights into the experience of professionals with negative opinions of or concerns with the LCP-I. A more comprehensive approach to professional training in palliative care is needed and may envisage the development of new interventions aimed at improving the quality of care throughout the illness trajectory.

The Liverpool Care Pathway for cancer patients dying in hospital medical wards: a before-after cluster phase II trial of outcomes reported by family members.

BACKGROUND: Hospital is the most common place of cancer death but concerns regarding the quality of end-of-life care remain. AIM: Preliminary assessment of the effectiveness of the Liverpool Care Pathway on the quality of end-of-life care provided to adult cancer patients during their last week of life in hospital. DESIGN: Uncontrolled before-after intervention cluster trial. SETTINGS/PARTICIPANTS: The trial was performed within four hospital wards participating in the pilot implementation of the Italian version of the Liverpool Care Pathway programme. All cancer patients who died in the hospital wards 2-4 months before and after the implementation of the Italian version of Liverpool Care Pathway were identified. A total of 2 months after the patient's death, bereaved family members were interviewed using the Toolkit After-Death Family Interview (seven 0-100 scales assessing the quality of end-of-life care) and the Italian version of the Views of Informal Carers - Evaluation of Services (VOICES) (three items assessing pain, breathlessness and nausea-vomiting). RESULTS: An interview was obtained for 79 family members, 46 (73.0%) before and 33 (68.8%) after implementation of the Italian version of Liverpool Care Pathway. Following Italian version of Liverpool Care Pathway implementation, there was a significant improvement in the mean scores of four Toolkit scales: respect, kindness and dignity (+16.8; 95% confidence interval = 3.6-30.0; p = 0.015); family emotional support (+20.9; 95% confidence interval = 9.6-32.3; p < 0.001); family self-efficacy (+14.3; 95% confidence interval = 0.3-28.2; p = 0.049) and coordination of care (+14.3; 95% confidence interval = 4.2-24.3; p = 0.007). No significant improvement in symptom' control was observed. CONCLUSIONS: These results provide the first robust data collected from family members of a preliminary clinically significant improvement, in some aspects, of quality of care after the implementation of the Italian version of Liverpool Care Pathway programme. The poor effect for symptom control suggests areas for further innovation and development.

Feasibility of assessing quality of care at the end of life in two cluster trials using an after-death approach with multiple assessments.

BACKGROUND: In 2009 two randomised cluster trials took place to assess the introduction of the Italian Version of the Liverpool Care Pathway in hospitals and hospices. Before and after data were gathered. The primary aim of this study is to evaluate the feasibility of using a combination of assessment methods aimed at different proxy respondents to create a means of measuring quality of care at the end of life. We also aim to explore whether there are differences in response to this approach between the hospice and hospital inpatient settings. METHODS: A retrospective design was used. Eligible deaths were traced through death registries, and proxies were used to give information. Four procedures of assessment were used to measure different dimensions. Feasibility was assessed through compliance and adherence to the study instruments, and measured against standards derived from previous after-death studies. The proxy caregiver's rating of the study tools was also measured, to gauge feasibility and effectiveness. All consecutive cancer deaths that occurred in the study period were eligible. In both trials, deaths were excluded if the patient was a relative of hospital/hospice staff. 145 patients were recruited from the Hospital setting, and 127 from Hospice. RESULTS: A high proportion of non-professional caregivers were interviewed - in both hospital (76.6%) and hospice (74.8%). There was no significant difference in the median number of days in each setting. 89.0% of hospital patients' GPs and 85.0% of hospice patients' GPs were interviewed. Care procedures were recorded in all hospice cases, and were missing in only 1 hospital case.52.7% of Hospital patients' relatives and 64.12% Hospice relatives were assessed to have been caused a low level of distress through the study. CONCLUSIONS: The data shows high levels of compliance and adherence to the study instruments. This suggests that this approach to assessing quality of care is feasible, and this coupled with low levels of distress caused by the study instruments suggest effectiveness. There were no substantial differences between the hospice and hospital settings.

Content and Face Validity of the Evaluation Tool of Health Information for Consumers (ETHIC): Getting Health Information Accessible to Patients and Citizens.

BACKGROUND: Health information concerns both individuals' engagement and the way services and professionals provide information to facilitate consumers' health decision making. Citizens' and patients' participation in the management of their own health is related to the availability of tools making health information accessible, thus promoting empowerment and making care more inclusive and fairer. A novel instrument was developed (Evaluation Tool of Health Information for Consumers-ETHIC) for assessing the formal quality of health information materials written in Italian language. This study reports ETHIC's content and face validity. METHODS: A convenience sample of 11 experts and 5 potential users was involved. The former were requested to evaluate relevance and exhaustiveness, the latter both readability and understandability of ETHIC. The Content Validity Index (CVI) was calculated for ETHIC's sections and items; experts and potential users' feedback were analyzed by the authors. RESULTS: All sections and most items were evaluated as relevant. A new item was introduced. Potential users provided the researchers with comments that partly confirmed ETHIC's clarity and understandability. CONCLUSIONS: Our findings strongly support the relevance of ETHIC's sections and items. An updated version of the instrument matching exhaustivity, readability, and understandability criteria was obtained, which will be assessed for further steps of the validation process.

Mindfulness-based therapies for cancer patients and families: a systematic review.

BACKGROUND: Mindfulness-based therapies (MBTs) addressed to patients with cancer have been widely studied in the last two decades, and their efficacy has been systematically reviewed and meta-analysed. Although findings from literature highlight benefits of MBTs on several patients' health outcomes, these should be appraised taking into consideration the characteristics of the selected studies. In this systematic review, we summarised the current evidence of the efficacy of MBTs in improving the quality of life of both patients with cancer and their relatives, with a focus on the methodological quality, type of MBT evaluated and population involved in existing randomised controlled trials (RCTs). METHODS: We searched English language articles published until February 2021. Couples of authors independently applied inclusion criteria and extracted findings. Thirty RCTs were included. RESULTS: Nearly half of the studies were performed in English-speaking countries outside of Europe, with females diagnosed with breast cancer. Most considered heterogeneous phases of illness; one study only was performed on relatives. In most cases, different measures were employed to evaluate the same outcome. The efficacy of MBTs has been demonstrated in 25 of the 30 included articles. The methodological quality of RCTs was acceptable. CONCLUSION: The heterogeneity of studies' characteristics makes findings on the efficacy of MBTs poorly informative with reference to different clinical and cancer-related psychological conditions. Studies on more homogeneous samples by cancer site and phase, as well as performed in different cultural contexts, could provide a basis for better evaluating and targeting MBTs' protocols for the specific needs of patients with cancer and their relatives.