Single early palliative care intervention added to usual oncology care for patients with advanced cancer: A randomized controlled trial (SENS Trial).

BACKGROUND: International oncology societies recommend early palliative care. Specific models to integrate early palliative care efficiently into clinical practice are debated. The authors designed a study to look at the quantitative and qualitative outcomes of an early palliative care intervention in oncological care to decrease stress and improve quality of life. AIMS: To compare a single structured early palliative care intervention added to a usual oncology care in terms of distress and health-related quality of life at baseline compared to 6 months after enrollment. DESIGN: This multicenter randomized controlled trial (NCT01983956) enrolled adult patients with advanced cancer. Participants were either randomly assigned to usual oncology care alone or usual care plus a structured early palliative care intervention. SETTING/PARTICIPANTS: One hundred fifty adult patients with a variety of advanced cancer diagnoses were randomized. Seventy-four participants were in the intervention and 76 participants in the control group. The primary outcome was the change in patient distress assessed by the National Comprehensive Cancer Network distress thermometer at 6 months. Health-related quality of life, the secondary outcome, was assessed by the Functional Assessment of Cancer Therapy-General Questionnaire. RESULTS: The results showed no significant effect of the early palliative care intervention neither on patient distress nor on health-related quality of life. CONCLUSION: The addition of an early intervention to usual care for patients with advanced cancer did not improve distress or quality of life. Thus, patients may need more intensive early palliative care with continuous professional support to identify and address their palliative needs early.

An early palliative care intervention can be confronting but reassuring: A qualitative study on the experiences of patients with advanced cancer.

BACKGROUND: Intervention trials confirm that patients with advanced cancer receiving early palliative care experience a better quality of life and show improved knowledge about and use of palliative care services. To involve patients in future health-care decisions, health professionals should understand patients' perspectives. However, little is known about how patients' experience such interventions. AIM: To explore advanced cancer patients' experiences with a structured early palliative care intervention, its acceptability and impact on the patients' life including influencing factors. DESIGN: Qualitative content analysis of in-depth, semi-structured interviews. SETTING/PARTICIPANTS: Patients with various advanced cancer diagnoses were enrolled in a multicenter randomized controlled trial (NCT01983956), which investigated the impact of "Symptoms, End-of-life decisions, Network, Support," a structured early palliative care intervention, on distress. Of these, 20 patients who underwent the intervention participated in this study. RESULTS: Participants received the intervention well and gained a better understanding of their personal situation. Patients reported that the intervention can feel "confronting" but with the right timing it can be confirming and facilitate family conversations. Patients' personal background and the intervention timing within their personal disease trajectory influenced their emotional and cognitive experiences; it also impacted their understanding of palliative care and triggered actions toward future care planning. CONCLUSION: Early palliative care interventions like "Symptoms, End-of-life decisions, Network, Support" may provoke emotions and feel "confrontational" often because this is the first time when issues about one's end of life are openly discussed; yet, advanced cancer patients found it beneficial and felt it should be incorporated into routine care.

The Oncological Patient in the Palliative Situation.

Palliative care approaches patients and their suffering with a bio-psycho-social-spiritual model. Thus, it is the strength of palliative care to complement the diagnosis driven approach of medical cancer care by a problem and resources-based assessment, participatory care plan and person-directed interventions. Interventions need to reflect timely prognosis, target population (the patient, the family carer, the professional) and level of trust and remaining energy. In palliative care the relevance of psycho-oncological aspects in the care of the terminally ill is considerable in the understanding of the overall suffering of patients approaching death and their loved ones and in their care and support. There is little evidence to date in terms of clinical benefit of specific psycho-oncological interventions in the last months or weeks of life, but there is evidence on effects of stress reduction and reduced anxiety if locus of control can stay within the patient as long as possible. One major challenge in psychosocial and palliative care research, however, is defining patient relevant outcomes.

Framework for Evaluating the Impact of Advanced Practice Nursing Roles.

PURPOSE: To address the gap in evidence-based information required to support the development of advanced practice nursing (APN) roles in Switzerland, stakeholders identified the need for guidance to generate strategic evaluation data. This article describes an evaluation framework developed to inform decisions about the effective utilization of APN roles across the country. APPROACH: A participatory approach was used by an international group of stakeholders. Published literature and an evidenced-based framework for introducing APN roles were analyzed and applied to define the purpose, target audiences, and essential elements of the evaluation framework. Through subsequent meetings and review by an expert panel, the framework was developed and refined. FINDINGS: A framework to evaluate different types of APN roles as they evolve to meet dynamic population health, practice setting, and health system needs was created. It includes a matrix of key concepts to guide evaluations across three stages of APN role development: introduction, implementation, and long-term sustainability. For each stage, evaluation objectives and questions examining APN role structures, processes, and outcomes from different perspectives (e.g., patients, providers, managers, policy-makers) were identified. CONCLUSIONS: A practical, robust framework based on well-established evaluation concepts and current understanding of APN roles can be used to conduct systematic evaluations. CLINICAL RELEVANCE: The evaluation framework is sufficiently generic to allow application in developed countries globally, both for evaluation as well as research purposes.

The oncological patient in the palliative situation.

Palliative care approaches the patient and his or her suffering with a biopsychosocial-spiritual model. Thus, it is the strength of palliative care to complement the diagnosis driven approach of medical cancer care by a problem and resources-based assessment, participatory care plan, and patient-directed interventions. Interventions need to reflect timely prognosis, target population (the patient, the family carer, the professional), and level of trust and remaining energy. In palliative care the relevance of psycho-oncological aspects in the care of the terminally ill is considerable in the understanding of the overall suffering of patients approaching death and their loved ones and in their care and support. There is little evidence to date in terms of clinical benefit of specific psycho-oncological interventions in the last months or weeks of life, but there is evidence on effects of stress reduction and reduced anxiety if locus of control can stay within the patient as long as possible. One major difficulty in psychosocial research at the end-of-life, however, is defining patient relevant outcomes.

An economic evaluation of an early palliative care intervention among patients with advanced cancer.

BACKGROUND: Early integration of palliative care into oncology care has shown positive effects on patient symptoms and quality of life. It may also reduce health care costs. However given the heterogeneity of settings and interventions and the lack of information on the minimally effective dose for influencing care utilisation and costs, it remains uncertain whether early palliative care reduces costs. OBJECTIVES: We sought to determine whether an early palliative care intervention integrated in usual oncology care in a Swiss hospital setting reduced utilisation and costs of health care in the last month of life when compared with usual oncology care alone. METHODS: We performed a cost-consequences analysis alongside a multicentre trial. We extracted costs from administrative health insurance data and health care utilisation from family caregiver surveys to compare two study arms: usual oncology care and usual oncology care plus the palliative care intervention. The intervention consisted of a single-structured, multiprofessional conversation with the patient about symptoms, end-of-life decisions, network building and support for carers (SENS). The early palliative care intervention was performed within 16 weeks of the diagnosis of a tumour stage not amenable or responsive to curative treatment. RESULTS: We included 58 participants with advanced cancer in our economic evaluation study. Median overall health care costs in the last month of life were 7892 Swiss Francs (CHF) (interquartile range: CHF 5637-13,489) in the intervention arm and CHF 8492 [CHF 5411-12,012] in the control arm. The average total intervention treatment cost CHF 380 per patient. Integrating an early palliative care intervention into usual oncology care showed no significant difference in health care utilisation or overall health care costs between intervention and control arms (p = 0.98). CONCLUSION: Although early palliative care is often presented as a cost-reducing care service, we could not show a significant effect of the SENS intervention on health care utilisation and costs in the last month of life. However, it may be that the intervention was not intensive enough, the timeframe too short or the study population too small for measurable effects. Patients appreciated the intervention. Single-structured early palliative care interventions are easy to implement in clinical practice and present low treatment costs. Further research about the economic impact of early palliative care should focus on extracting large, detailed cost databases showing potential shifts in cost and cost-effectiveness. CLINICAL TRIALS: gov Identifier: NCT01983956.

Systematic review of oral cryotherapy for management of oral mucositis caused by cancer therapy.

PURPOSE: This systematic review analyzed the strength of the literature and defined clinical practice guidelines for the use of oral cryotherapy for the prevention and/or treatment of oral mucositis caused by cancer therapy. METHODS: A systematic review on relevant oral cryotherapy studies indexed prior to 31 December 2010 was conducted by the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO) using OVID/MEDLINE, with publications selected for review based on defined inclusion and exclusion criteria. Findings from the reviewed studies were integrated into guidelines based on the overall level of evidence for each intervention. Guidelines were classified into three types: recommendation, suggestion, or no guideline possible. RESULTS: Twenty-two clinical studies and two meta-analyses were analyzed. Results were compared with the MASCC/ISOO guidelines published in 2007. The recommendation for the use of oral cryotherapy to prevent oral mucositis in patients receiving bolus fluorouracil (5-FU) was maintained, in agreement with the 2007 guidelines. A suggestion for use of oral cryotherapy to prevent oral mucositis in patients receiving high-dose melphalan as conditioning regimen with or without total body irradiation for HCST was revised from the 2007 guidelines. No guideline was possible for any other intervention, due to insufficient evidence. CONCLUSIONS: The evidence continues to support the use of oral cryotherapy for prevention of oral mucositis in patients receiving bolus 5-FU chemotherapy or high-dose melphalan. This intervention is consistent with the MASCC/ISOO guidelines published in 2007. The literature is limited by the fact that utilization of a double-blind study design is not feasible. Future studies that compare efficacy of oral cryotherapy with other mucositis agents in patients receiving chemotherapy with relatively short plasma half-lives would be useful.

Swallowing dysfunction in cancer patients.

PURPOSE: Dysphagia (swallowing dysfunction) is a debilitating, depressing, and potentially life-threatening complication in cancer patients that is likely underreported. The present paper is aimed to review relevant dysphagia literature between 1990 and 2010 with a focus on assessment tools, prevalence, complications, and impact on quality of life in patients with a variety of different cancers, particularly in those treated with curative chemoradiation for head and neck cancer. METHODS: The literature search was limited to the English language and included both MEDLINE/PubMed and EMBASE. The search focused on papers reporting dysphagia as a side effect of cancer and cancer therapy. We identified relevant literature through the primary literature search and by articles identified in references. RESULTS: A wide range of assessment tools for dysphagia was identified. Dysphagia is related to a number of factors such as direct impact of the tumor, cancer resection, chemotherapy, and radiotherapy and to newer therapies such as epidermal growth factor receptor inhibitors. Concomitant oral complications such as xerostomia may exacerbate subjective dysphagia. Most literature focuses on head and neck cancer, but dysphagia is also common in other types of cancer. CONCLUSIONS: Swallowing impairment is a clinically relevant acute and long-term complication in patients with a wide variety of cancers. More prospective studies on the course of dysphagia and impact on quality of life from baseline to long-term follow-up after various treatment modalities, including targeted therapies, are needed.

Public perception of palliative care: a survey of the general population.

BACKGROUND: The public's view of palliative care often involves its potential to improve of quality-of-life as well as its use as a last resource prior to death. OBJECTIVE: To obtain an idea of the image of palliative care held by the public in the German-speaking part of Switzerland, the authors sought to understand (1) the perceptions of palliative care and the (2) elements important when thinking about their own end of life. METHODS AND SAMPLE: A qualitative design with an inductive reasoning approach based on Mayring (2014) was chosen. Visitors at an exhibition about palliative care in six locations provided hand-written answers on provided cards to two statements: (1) if I hear the term 'Palliative Care' I think of … and (2) when thinking about my own end of life, the following is important to me …. RESULTS: Answers of 199 visitors (mean age 52, mostly in a good/very good health status) were analysed. In response to hearing the term palliative care, six areas were categorized: (1) the main focus; (2) ways of providing palliative care; (3) the best timing; (4) places where palliative care is provided; (5) who is seen as provider and (6) outcomes of palliative care. Five categories to the statement about their own end-of-life were identified: (1) the ability to look back on a fulfilled life and being satisfied; (2) maintaining trusting relationships until the end; (3) organizing affairs and having everything settled; (4) having their family being cared for and (5) relief of suffering with the support of knowledgeable people. CONCLUSION: Palliative care was mostly associated with positive terms acknowledging an interprofessional approach. Maintaining one's dignity as well as dying without suffering pointed at the persisting stigma that palliative care is mainly limited to end-of-life care. The results may help healthcare professionals to better understand how the public view palliative care.

[Telemedicine in Palliative Care: Digital Communication in a Relationship-Based Speciality - Does It Make Sense?] / Telemedizin in der Palliative Care: Digitale Kommunikation in einem beziehungsbasierten Fachgebiet ­ ist das sinnvoll?

Telemedicine in Palliative Care: Digital Communication in a Relationship-Based Speciality - Does It Make Sense? Abstract. Telemedicine in palliative care is established especially in countries with large geographical distances. Digital forms of communication (virtual consultations) are most frequently used and well-accepted by patients and caregivers. The main benefit lies in the reduction of the access barrier in the outpatient setting. Advantages are stress reduction for patients (travel, accessibility) and reduction in the care burden for relatives. Additional benefits compared to the physical visit for symptom-control, quality of life and costs are unclear. Risks are influenced by the lack of physical interaction and data security. To what extent telepalliative care makes sense in a high-density health system is difficult to predict. It is therefore important to use these new tools in a carefully adapted and scientifically verified way.

Roles and Responsibilities of Nurses in Advance Care Planning in Palliative Care in the Acute Care Setting: A Scoping Review.

Palliative care focuses on symptom management, discussion of treatment and care decisions, network organization, and support of the family. As part of the advance care planning (ACP) process, staff nurses in the acute care setting are often involved in all of the above areas. It is yet unclear what nurses' roles and responsibilities are and what skills are needed in the ACP process. The themes that staff nurses and advanced practice registered nurses (APRNs) discuss in relationship to ACP are manifold. This scoping review demonstrates that staff nurses' core role is advocating for the wishes and values of patients with any life-limiting disease. Staff nurses also serve as facilitators, educators, and advocates to help start ACP conversations and ease patients' transitions between settings based on well-discussed decisions. To be able to engage in ACP discussions, APRNs must have excellent communication skills. Continuous training to improve these skills is mandatory. In the future, clarifying the contribution of staff nurses and APRNs in the ACP process in relation to other members of the interprofessional team can lay the groundwork for improved interprofessional collaboration.

Does Time for (in)Direct Nursing Care Activities at the End of Life for Patients With or Without Specialized Palliative Care in a University Hospital Differ? A Retrospective Analysis.

BACKGROUND: Nurses' end of life (EoL) care focuses on direct (eg, physical) and indirect (e,g, coordination) care. Little is known about how much time nurses actually devote to these activities and if activities change due to support by specialized palliative care (SPC) in hospitalized patients. AIMS: (1) Comparing care time for EoL patients receiving SPC to usual palliative care (UPC);(2) Comparing time spent for direct/indirect care in the SPC group before and after SPC. METHODS: Retrospective observational study; nursing care time for EoL patients based on tacs® data using nonparametric and parametric tests. The Swiss data method tacs measures (in)direct nursing care time for monitoring and cost analyses. RESULTS: Analysis of tacs® data (UPC, n = 642; SPC, n = 104) during hospitalization before death in 2015. Overall, SPC patients had higher tacs® than UPC patients by 40 direct (95% confidence interval [CI]: 5.7-75, P = .023) and 14 indirect tacs® (95% CI: 6.0-23, P < .001). No difference for tacs® by day, as SPC patients were treated for a longer time (mean number of days 7.2 vs 16, P < .001).Subanalysis for SPC patients showed increased direct care time on the day of and after SPC (P < .001), whereas indirect care time increased only on the day of SPC. CONCLUSIONS: This study gives insight into nurses' time for (in)direct care activities with/without SPC before death. The higher (in)direct nursing care time in SPC patients compared to UPC may reflect higher complexity. Consensus-based measurements to monitor nurses' care activities may be helpful for benchmarking or reimbursement analysis.

Development and Use of the 'SENS'-Structure to Proactively Identify Care Needs in Early Palliative Care-An Innovative Approach.

Anticipatory planning for end of life requires a common language for discussion among patients, families, and professionals. Studies show that early Palliative Care (PC) interventions based on a problem-oriented approach can improve quality of life, support decision-making, and optimize the timing of medical treatment and transition to hospice services. The aim of this quality-improvement project was to develop a pragmatic structure meeting all clinical settings and populations needs. Based on the Medical Research Council (MRC) framework, a literature review identifying approaches commonly used in PC was performed. In addition, more than 500 hospital-based interprofessional consultations were analyzed. Identified themes were structured and compared to published approaches. We evaluated the clinical usefulness of this structure with an online survey among professionals. The emerged 'SENS'-structure stands for: Symptoms patients suffer from; End-of-life decisions; Network around the patient delivering care; and Support for the carer. Evaluation among professionals has confirmed that the 'SENS'-structure covers all relevant areas for anticipatory planning in PC. 'SENS' is useful in guiding patient-centered PC conversations and pragmatic anticipatory planning, alongside the regular diagnosis-triggered approach in various settings. Following this approach, 'SENS' may facilitate systematic integration of PC in clinical practice. Depending on clearly defined outcomes, this needs to be confirmed by future randomized controlled studies.

Guidelines for the assessment of oral mucositis in adult chemotherapy, radiotherapy and haematopoietic stem cell transplant patients.

Oral mucositis (OM) is a serious consequence of some chemotherapy and radiotherapy regimens. A number of reliable instruments are available to assess OM, but none are universally accepted. A unique collaboration of multi-disciplinary experts from Europe was formed to make recommendations on OM assessment, based on a systematic literature review and the experts' experience. The main recommendations are listed. There should be a comprehensive baseline assessment. OM should be frequently assessed using a standardised instrument, or a combination of instruments. Physical, functional and subjective changes should be measured. Subjective measures should be assessed prior to any physical examination. The use of pain scoring, in particular patient self-reporting, should form part of any OM assessment. Any assessment instrument should be validated, easy to use and comfortable for the patient. Training of, and monitoring in, the use of the instrument is vital to successful monitoring of OM.

[The contribution of oncology nursing to the Swiss Research Agenda for Nursing - SRAN]. / Der Beitrag der Onkologiepflege zur Swiss Research Agenda for Nursing - SRAN.

Worldwide, cancer remains the second most frequent cause of death in adults and children. A cancer diagnosis often marks the beginning of therapies that may continue over months and years. These therapies frequently consist in surgical interventions in combination with chemotherapy and radiotherapy. For all healthcare professionals involved, cancer also signifies a very complex illness with high demands. It is therefore important to identify research priorities in order to successfully and comprehensively address these demands and to provide high quality patient care. In order to identify research priorities in oncology care in Switzerland, a systematic review of literature was conducted. A total of 30 research priorities emerged from the literature. In accordance with SRAN guidelines, 25 were passed on to the SRAN. The systematic identification of research priorities in oncology nursing has, for the first time, resulted in a list of topics in need of investigation in Switzerland. Completing the list of research priorities for oncology nursing with an updated systematic review of literature and presenting it to a larger and more representative group of oncology nurses, experts, and nurse scientists with oncology nursing experience for assessment and valuation, will be crucial for any future revision of the SRAN. In the future, it will be indispensable to include patients and their families in the process.

Palifermin for patients with haematological malignancies: shifting nursing practice from symptom relief to prevention of oral mucositis.

Oral mucositis (OM) is an extremely debilitating side effect of certain high-dose chemotherapy and radiotherapy regimens. It is especially prevalent in patients with haematological malignancies who undergo myeloablative therapy and autologous haematopoietic stem cell transplantation (HSCT). Severe erosion of the lining of the oral cavity can make patients' everyday activities, including eating, drinking, swallowing, and talking, difficult or even impossible. Palifermin (Kepivance) was approved in Europe in 2005 for both prevention and treatment of this painful condition. It works at the epithelial level to help protect cells in the mouth and throat from the damage caused by chemotherapy and radiation, and to stimulate growth and development of new epithelial cells to build up the mucosal barrier. In the pivotal clinical trial, palifermin reduced the incidence, severity, and duration of severe OM. Palifermin was also well-tolerated; common adverse reactions reported included rash, pruritus, erythema, edema, pain, fever, arthralgia, mouth or tongue disorders, and taste alteration. In this article, nurses who are skilled in caring for patients undergoing HSCT review their clinical experience with palifermin, sharing practical advice about its reconstitution, dosing, and administration. By familiarising themselves with the use of palifermin, nurses can influence a shift in clinical practice away from OM symptom management to the more satisfactory situation of protecting patients against severe OM.

The impact of early palliative care on the quality of care during the last days of life: what does the evidence say?

PURPOSE OF REVIEW: The aim of this review is to critically appraise the existing evidence on 'early palliative care' (EPC), discuss its relationship with advance care planning, and to reflect on the impact of EPC on the quality of care provided during the last days of life. RECENT FINDINGS: There are indicators that EPC may help to avoid aggressive treatment, shorten hospital stay, improve overall quality of life, and to see more frequently dying and death at the preferred place of care. SUMMARY: The evidence from randomized controlled trials supports the integration of palliative care early in the disease trajectory. However, in terms of outcomes and quality indicators for care in the last days of life, evidence is still lacking. Predominantly, when it comes to the outcomes which may be more difficult to assess, such as spiritual aspects, or the social network, for which more comprehensive information is needed. These outcomes should not be neglected in palliative care studies, particularly when they can provide meaningful information about patient and family adjustment, and focus on psychosocial aspects rather than physical symptom control.

Recommendations for symptom management in women with vulvar neoplasms after surgical treatment: An evidence-based guideline.

PURPOSE: To develop an evidence-based guideline for nurses and other health care professionals involved in pre- and postsurgical care of women with vulvar cancer (VC) or vulvar intraepithelial neoplasia (VIN). METHODS: This evidence-based guideline was developed according to six domains of the methodological framework AGREE II. Literature research with focus on cancer care, symptom management and self-management/counselling was conducted from April to August 2013 in the databases CINAHL, Cochrane Library, PsycINFO, PubMed as well as in 14 international guideline databases. Interdisciplinary experts (n = 14) were involved in the development of the guideline from December 2013 to January 2014. This guideline is currently tested in the WOMAN-PRO II RCT (Clinical Trial No: NCT01986725). RESULTS: For the definition of recommendations, five guidelines, one meta-analysis, two systematic reviews and two randomized controlled trials were included. In total, 24 recommendations were formulated to answer 22 clinical questions based on patients' perspective and experts' opinion. Evidence ranged from 3.5 to 5 (3.5 = weak evidence and/or clinical relevance, 5 = best evidence and/or clinical relevance). The recommendations were subsumed under different themes regarding physical, psychological and psychosocial aspects. CONCLUSIONS: The clinical practice guideline developed in this study firstly provides recommendations for symptom management issues focusing on self-management interventions for women with VC or VIN. As an interdisciplinary guideline it should be used in addition to the existing medical guideline in the German speaking context.