Background:Providing oncological care to children is demanding and ethical issues concerning what is best for the child can contribute to moral distress.Objectives:To explore healthcare professionals’ experiences of situations that generate moral distress in Swedish paediatric oncology.Research design:In this national study, data collection was conducted using the Swedish Moral Distress Scale-Revised. The data analysis included descriptive statistics and non-parametric analysis of differences between groups.Participants and research context:Healthcare professionals at all paediatric oncology centres in Sweden were invited to participate. A (...) total of 278 healthcare professionals participated. The response rate was 89%.Ethical considerations:In its advisory statement, the Regional Ethical Review Board decided that the study was of such a nature that the legislation concerning ethical reviews was not applicable. All participants received written information about the aim of the study and confidentiality. Participants demonstrated their consent by returning the survey.Findings:The two situations with the highest moral distress scores concerned lack of competence and continuity of personnel. All professional groups reported high levels of disturbance. Nurses rated significantly higher frequencies and higher total Moral Distress Scale scores compared to medical doctors and nursing assistants.Discussion:Lack of competence and continuity, as the two most morally distressing situations, confirms the findings of studies from other countries, where inadequate staffing was reported as being among the top five morally distressing situations. The levels of total Moral Distress Scale scores were more similar to those reported in intensive care units than in other paediatric care settings.Conclusion:The two most morally distressing situations, lack of competence and continuity, are both organisational in nature. Thus, clinical ethics support services need to be combined with organisational improvements in order to reduce moral distress, thereby maintaining job satisfaction, preventing a high turnover of staff and ensuring the quality of care. (shrink)

The image of “the good nurse” is mainly studied from the perspective of nurses, which often does not match the image held by patients. Therefore, a descriptive study was conducted to examine oncology patients’ perceptions of “the good nurse” and the influence of patient- and context-related variables. A cross-sectional, comparative, descriptive design was used. The sample comprised 557 oncology patients at one of six Flemish hospitals, where they were treated in an oncology day-care unit, oncology hospital (...) ward, or palliative care unit. Data were collected using the Flemish Care-Q instrument. Factor analysis summarised the most important characteristics of “the good nurse”. We reassessed the reliability and construct validity of the Flemish Care-Q and examined the influence of patient- and context-related variables on patient perceptions. Using factor analysis, we grouped the different items of the Flemish Care-Q according to three characteristics: “the good nurse” (I) has a supportive and communicative attitude towards patient and family, (II) is competent and employs a professional attitude, and (III) demonstrates personal involvement towards patient and family. Median factor scores of Factors I, II, and III, respectively, were 8.00, 9.00, and 8.00 (varying from 1, not important, to 10, very important). In order of importance, Factors II, I, and III were identified as valuable characteristics of “the good nurse”. Gender, care setting, and province were influential variables. As perceived by oncology patients, “the good nurse” has a broad range of qualities, of which competence and professionalism are the most valuable. (shrink)

The National Cancer Institute’s Thesaurus (NCIT) has been created with the goal of providing a controlled vocabulary which can be used by specialists in the various sub-domains of oncology. It is intended to be used for purposes of annotation in ways designed to ensure the integration of data and information deriving from these various sub-domains, and thus to support more powerful cross-domain inferences. In order to evaluate its suitability for this purpose, we examined the NCIT’s treatment of the kinds (...) of entities which are fundamental to an ontology of colon carcinoma. We here describe the problems we uncovered concerning classification, synonymy, relations and definitions, and we draw conclusions for the work needed to establish the NCIT as a reference ontology for the cancer domain in the future. (shrink)

Definition of the problem: A `experimental treatment' is defined as the use of a not yet approved medical treatment or product in a single patient outside the scope of regular clinical trials. Especially in oncology the patient is usually in a desperate situation and does not respond to other treatments. Even if he or she is fully informed about the risks he or she may occasionally make an irrational decision.Discussion of the problem: The moral problems in experimental treatments have (...) to do with the medical and scientific quality of the treatment and the patient-physician relationship. It is argued that there are also moral duties for pharmaceutical manufacturers and health insurrance companies.Conclusion: A regulation of experimental treatment trials is necessary both for physicians and for pharmaceutical manufacturers. (shrink)

The objective of this study was to determine whether consent forms in oncology clinical trials of commercially available treatments inform subjects that they may be able to obtain the treatments being investigated without participating in research. We acquired consent forms from a random sample of U.S. oncology clinical trials in the ClinicalTrials.gov database. We then examined a subgroup of the sample consisting of studies in which the treatments under investigations were commercially available. Less than 20% of the consent (...) forms in that group disclosed to subjects that they may be able to obtain the treatment being investigated without participating in the study . Our results suggest that potential research subjects are frequently not informed about important alternatives to research participation in studies involving commercially available treatments, which is a violation of both ethical and regulatory standards. (shrink)

BackgroundDiagnosis and treatment of differentiated thyroid carcinomas cause anxiety and depression. Additionally, these patients suffer hormonal alterations that are associated with psychological symptoms. This study aims to evaluate the effectiveness of a psycho-oncological intervention based on counseling to reduce anxiety and depression related to the treatment in patients with DTC.MethodsA non-randomized controlled study, with two groups [experimental group, n = 37, and control group, n = 38] and baseline and posttreatment measures, was designed. Patients in the EG received a psycho-oncological (...) intervention based on counseling in addition to the standard treatment. The independent variable was the assigned group and the dependent one was the evolution of anxiety and depression, which were analyzed separately, and both were evaluated using the Hospital Anxiety and Depression Scale. Other relevant covariables related to the quality of life were also analyzed using Short Form-36 Health Survey and Psychological General Wellbeing Index scales.ResultsThe difference of the posttreatment-baseline variation showed a statistically significant reduction in anxiety and depression in the EG in relation to the CG. The mean of the Psychological General Wellbeing Index scales score increased significantly in the EG and decreased significantly in the CG. All the baseline and the posttreatment scores of the variables evaluated showed a statistically significant improvement in the EG vs. the CG.ConclusionThis study demonstrates significant benefits of psycho-oncological intervention based on counseling in anxiety, depression, QoL, and wellbeing of the patient with differentiated thyroid carcinomas. (shrink)

BackgroundAlthough patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation (...) of important information in consent forms for these trials.MethodsThe study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial’s consent form. The location of information in the consent forms was compared to the participants’ suggestions for placement. Results34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the “Risks” section. 3/5(60%) consents did this.ConclusionsDesigning consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding. (shrink)

Until recently, cardiotoxicity in the setting of a malignant disease was attributed solely to the detrimental effects of chemo‐ and/or radio‐therapy to the heart. On this account, the focus was on the evaluation of well‐established cardiac biomarkers for the early detection of myocardial damage. Currently, this view has been revised. Cardiotoxicity is not restricted to a single organ but instead affects the endothelium as a whole. Indeed, it has come into light that not only cancer therapy but also malignant cells (...) per se can impair the cardiovascular system, through a paracrine and endocrine mode of action. Even more intriguingly, a clear interplay between molecular pathways involved in cancer and cardiovascular disease has become prevalent, suggesting a common nominator that governs the pathophysiology of these two entities. Taken together, our strategy in the quest of novel biomarkers in the emerging field of cardio‐oncology should be critically reshaped. (shrink)

Background: It is stated that the communication and disease experiences of paediatric patients, especially paediatric oncology patients, with healthcare professionals are completely different from those of adults. Objective: The aim of this study was to determine the definitions of a good physician and good nurse provided by elementary school-age oncology patients. Research design: In this qualitative research, data were collected through semi-structured individual interviews. The data were evaluated thorough thematic analysis. Participants and research context: Eighteen children hospitalised due (...) to cancer in paediatric oncology and haematology clinics of a university hospital in Turkey. Ethical considerations: Permission to conduct the study was obtained from the Institution’s Ethics Committee. The objectives of this study were explained to the participants and families, and written consent was obtained from them. Also, participants were assured that necessary measures would be taken to protect their anonymity and confidentiality. Findings: The definitions of children were based on five main themes: interpersonal relationships, virtues, professional responsibility, security and individual characteristics. Conclusion: Children conveyed important messages to health professionals. They emphasised that a good physician and good nurse should communicate well, not only with themselves but also with their family. In addition, children were sensitive about health professionals who played with them and actively participated in the treatment by informing them about the disease. Meeting the expectations of children can be possible by improving the communication skills of physicians and nurses and by adding games and activities to the treatment and care plan. (shrink)

In many cases, the “therapeutic misconception” may be an unavoidable part of the imperfect process of recruitment and consent in medical researchPaul Appelbaum, Loren Roth, and Charles Lidz coined the term “therapeutic misconception” in 1982.1 They described it as the misconception that participating in research is the same as receiving individualised treatment from a physician. It referred to the research subject’s failure to appreciate that the aim of research is to obtain scientific knowledge, and that any benefit to the subject (...) is a by-product of that knowledge. More recent studies by Appelbaum and Lidz have shown that this phenomenon is just as pervasive now as it was twenty four years ago.2 The problem pertains not to any duty of care for researchers but to participants’ unfounded belief in the therapeutic potential of research.3 It is especially acute in phase I oncology trials, which aim to test the toxicity and highest tolerable dose of anticancer drugs.To remedy this situation, many have argued that both clinicians and researchers need to do more in explaining to subjects the differences between experimental research and standard care. Clinicians and researchers recruiting potential subjects for research must present information about the expected risks and benefits of participation in research in a more realistic and straightforward way.4 In one recent examination of consent forms for phase I oncology trials, Sam Horng et al found that, in the section on “benefit”, only one of 272 forms stated that the subjects were expected to benefit. They also found that 11 consent forms stated clearly that subjects would not benefit, 25 forms communicated uncertainty about benefit, and 5 forms said nothing about the chance of benefit. Interestingly, 139 forms alluded to the …. (shrink)

Data on advance directives in Brazil are lacking. This study aims to assess the understanding of oncologists regarding advance directives and the frequency with which they discuss advance directives and advance care planning with their patients in Brazil. This is an observational, descriptive and cross-sectional study, conducted with cclinical oncologists associated with the Brazilian Society of Clinical Oncology. Participants were invited to answer a questionnaire prepared by the authors. In total, 72 physicians answered the questionnaire, of which 73% were (...) under 45 years old and 56% worked in oncology for less than 10 years. Regarding the limits of intervention and end-of-life care during treatment, 54.2% of respondents reported not discussing it. Although 67% of oncologists know the term advance directives, they do not develop them with their patients and 57.2% do not perform advance care planning. Most oncologists in this study do not set advance care planning and advance directives for most patients. (shrink)

BackgroundClinical Ethics Support Services 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.MethodsThe 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.ResultsTwenty-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.ConclusionsThe 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. (shrink)

Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences of (...) the pediatric oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents. Due to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes. (shrink)

Numerous ethical issues are raised in cancer treatment and research. Informed consent is challenging due to complex treatment modalities and prognostic uncertainty. Busy oncology clinics limit the ability of oncologists to spend time reinforcing patient understanding and facilitating end-of-life planning. Despite these issues and the ethics consultations they generate, clinical ethicists receive little if any focused education about cancer and its treatment. As the field of clinical ethics develops standards for training, we argue that a basic knowledge of cancer (...) should be included and offer an example of what cancer ethics training components might look like. We further suggest some specific steps to increase collaboration between clinical ethicists and oncology providers in the outpatient setting to facilitate informed consent and proactively identify ethical issues. (shrink)

Ethical concerns have been raised about the quality of informed consent by participants in phase 1 oncology trials. Interview surveys indicate that substantial proportions of trial participants do not understand the purpose of these trials—evaluating toxicity and dosing for subsequent efficacy studies—and overestimate the prospect of therapeutic benefit that they offer. In this article we argue that although these data suggest the desirability of enhancing the process of information disclosure and assessment of comprehension of the implications of study participation, (...) they do not necessarily invalidate consent by phase 1 trial participants. (shrink)

The oncological disease experience is counted as a wound in the body and mind attributable to a traumatic experience that fragments and disorients the person’s biography. The neoplasia leaves marks and scars in both somatic and existential level. The illness experience suggests to patient to look for meaning that cannot be unheard. The literature associating the concept of liminality in oncological disease to understand the process of meaning making. The definition of new horizons of meaning, generated by crossing the limen, (...) opens up a new self-awareness and worldview. The autopoietic dimension present in oncological disease reveals new scenarios of generativity and existential planning in the direction of self-realization in the cipher of the possible. The contribution presents the story of Anastasia, a 41-years-old nurse. A few months after her new marriage and close to a professional promotion, she receives the diagnosis of cholangiocarcinoma: a very aggressive, low-incidence, neoplasia, without specific therapeutic lines and with a negative prognosis. Anastasia’s words, thoughts and emotions, collected in the course of some testimonies in a university classroom, are analyzed and deciphered within the pedagogical paradigm, refering to the perspective of pedagogical problematicism and phenomenological pedagogy. (shrink)

Die öffentliche Diskussion um die „personalisierte Medizin“ legt nahe, dass mit diesem medizinischen Ansatz hohe Erwartungen an einen Beitrag zur klinischen Versorgung verbunden werden. Über die Wahrnehmungen und Bewertungen klinisch tätiger Ärzte ist jedoch wenig bekannt. Die vorliegende qualitative Interviewstudie gibt einen Einblick bezüglich des Einflusses „personalisierter Medizin“ auf die klinische Praxis aus ärztlicher Perspektive. Die Ärzte im vorliegenden Sample nehmen „personalisierte Medizin“ zwar als einen medizinischen Fortschritt wahr, sehen allerdings keine grundsätzliche Veränderung der bisherigen medizinischen Praxis. Als zentrales Problem (...) wird die Handhabung und Verwertung von molekulargenetischen Informationen für Diagnose und Therapie in der klinischen Praxis thematisiert. In Anbetracht der Ergebnisse muss infrage gestellt werden, ob „personalisierte Medizin“ nicht das Gegenteil von dem, was ihr Name nahe legt – eine personenorientiertere Medizin – bewirkt. Die Strategien im Umgang mit den Informationsmassen produzieren selbst neue Herausforderungen, die ein Hindernis für eine personenorientierte Medizin darstellen könnten. (shrink)

(2011). The Children's Oncology Group Routinely Applies “Lack of Efficacy” Interim Monitoring to Its Randomized Clinical Trials. The American Journal of Bioethics: Vol. 11, No. 3, pp. 18-19.

Principles of ethics -- Medical research and clinical trials -- Treatment decision making -- Palliative and end-of-life care -- Patient advocacy -- Communication and ethics -- Genetics and genomics -- The impact of ethical conflict and dilemmas on nurses -- Ethics consultation and education.

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in (...) these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. (shrink)

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in (...) these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. (shrink)

Background Physicians play a fundamental role in the care of patients at the end of life that includes knowing how to accompany patients, alleviate their suffering and inform them about their situation. However, in reality, doctors are part of this society that is reticent to face death and lack the proper education to manage it in their clinical practice. The objective of this study was to explore the residents’ concepts of death and related aspects, their reactions and actions in situations (...) pertaining to death in their practice, and their perceptions about existing and necessary training conditions. Methods A qualitative approach was used to examine these points in depth based on interviews conducted with seven oncology residents. Results Participants do not have a clear concept of death and, although it is seen as a common phenomenon, they consider it an enemy to beat. The situations to which respondents react more frequently with frustration and sadness after the death of patients were when they felt emotionally involved, if they identify with the patient, in cases of pediatric patients and with patients who refuse treatment. To deal with death, participants raise barriers and attempt to become insensitive. Although residents in this study recognize the importance of training to learn how to better deal with death, it seems they are not fully invested in reaching more of it. Conclusions Participants face death in a daily basis without the necessary training, which appears to impact them more than they are willing to accept. They do not achieve their goals managing situations regarding death as well as they assume they do. Despite recognizing the need of more training and support for better coping with death, they prefer to continue to learn from their experience. Trial registration Not applicable. (shrink)

BackgroundCancer patients often suffer from psychological distress during or after cancer treatment, but the use of psycho-oncological care among cancer patients is limited. One of the reasons might be that the way psycho-oncological care is organized, does not fit patients’ preferences. This study aimed to obtain detailed insight into cancer patients’ preferences regarding the organization of psycho-oncological care.Methods18 semi-structured interviews were conducted among cancer patients. Patients completed psycho-oncological treatment between 2015 and 2020 at the psychology department in a general hospital (...) or a center specialized in psychological cancer care in the Netherlands. The interview comprised questions related to preferences regarding the institute where to receive treatment, the psychologist who provides treatment, and the type of treatment, as well as questions related to experienced barriers and facilitators to receive psycho-oncological care. Interviews were digitally recorded and transcribed verbatim. Data were analyzed individually by two coders into key issues and themes.ResultsRegarding the institute, easy accessibility and prompt availability of psychol-oncological care were considered important. Regarding the psychologist, most participants had a strong preference to be treated by a psychologist specialized in cancer or other somatic diseases. Individual face-to-face therapy was preferred above other types of treatment. Several barriers were mentioned to receive psycho-oncological treatment, among which poor accessibility to psycho-oncological care, lack of knowledge on the possibilities for psycho-oncological treatment, and stigma. Most frequently mentioned facilitators were being assertive to ask for help, having a good relationship with the healthcare professional, and the integration of psycho-oncological support within medical cancer care.ConclusionFrom the patient’s perspective, the organization of psycho-oncological care for cancer patients should focus on easy accessibility and availability, delivered by specialized psychologists, and integration in medical cancer care. Online and group therapy are acceptable, but individual face-to-face therapy is preferred. It is warranted to increase awareness on psycho-oncological care targeting both patients and healthcare providers. (shrink)

BackgroundWorldwide, hepatobiliary cancers are frequent diseases and often accompanied by a poor prognosis. These cancers, with hepatocellular carcinoma and cholangiocarcinoma being the most frequent, are often associated with a considerable amount of psychological burden such as anxiety, depressiveness, and reduced health-related quality of life which may lead to psychiatric comorbidities. This systematic review gives an overview on psychological burden and on the effectiveness of psycho-oncological interventions for patients with HCC and CHC.MethodsThe databases PubMed, PubPsych, and PsycINFO were used and searched (...) using the following combination of terms: AND AND. Studies were eligible for inclusion if investigating patients affected with tumors of the liver and using diagnostic instruments to assess mental health symptoms and research concerning specific psycho-oncological interventions. In total, 1027 studies were screened by one author with regard to title and abstracts. Afterward, the two authors of the paper discussed inclusion of possible articles.ResultsTwelve studies focusing on distress, anxiety, and depression symptoms as well as quality of life among patients with HCC/CHC and three studies on psycho-oncological interventions were included. Patients suffering from hepatobiliary cancers often experience considerable psychological burden. A quarter of patients suffer from depressive symptoms; anxiety is even more common among these patients with almost 40%. The HRQOL of those affected is reduced in almost all areas, suicide rates increased and the level of distress is considerably increased in one third of patients even in comparison to those with other kinds of cancer. By psycho-oncological intervention the prevalence of depressive symptoms and anxiety can be reduced, while the quality of life and also the survival rate of patients with hepatobiliary cancer can be increased.Discussion and ConclusionPsychological burden is high in patients with hepatobiliary cancers as reflected in high levels of depressiveness and anxiety as well as reduced quality of life. The use of psycho-oncological interventions can reduce psychological burden and increase quality of life compared to patients receiving standard support only.Systematic Review Registration, identifier. (shrink)

This article provides an ethnographic account of how Big Data biology is produced, interpreted, debated, and translated in a Big Data-driven cancer clinical trial, entitled “Personalized OncoGenomics,” in Vancouver, Canada. We delve into epistemological differences between clinical judgment, pathological assessment, and bioinformatic analysis of cancer. To unpack these epistemological differences, we analyze a set of gazes required to produce Big Data biology in cancer care: clinical gaze, molecular gaze, and informational gaze. We are concerned with the interactions of these bodily (...) gazes and their interdependence on each other to produce Big Data biology and translate it into clinical knowledge. To that end, our central research questions ask: How do medical practitioners and data scientists interact, contest, and collaborate to produce and translate Big Data into clinical knowledge? What counts as actionable and reliable data in cancer decision-making? How does the explicability or translatability of genomic Big Data come to redefine or contradict medical practice? The article contributes to current debates on whether Big Data engenders new questions and approaches to biology, or Big Data biology is merely an extension of early modern natural history and biology. This ethnographic account will highlight how genomic Big Data, which underpins the mechanism of personalized medicine, allows oncologists to understand and diagnose cancer in a different light, but it does not revolutionize or disrupt medical oncology on an institutional level. Rather, personalized medicine is interdependent on different styles of thought, gaze, and practice to be produced and made intelligible. (shrink)

Background: Ethical climate and moral distress have been shown to affect nurses’ ethical behaviour. Despite the many ethical issues in paediatric oncology nursing, research is still lacking in the field. Research aim: To investigate paediatric oncology nurses’ perceptions of ethical climate and moral distress. Research design: In this cross-sectional study, data were collected using Finnish translations of the Swedish Hospital Ethical Climate Survey–Shortened and the Swedish Moral Distress Scale–Revised. Data analysis includes descriptive statistics and non-parametric analyses. Respondents and (...) research context: Ninety-three nurses, working at paediatric oncology centres in Finland, completed the survey. Ethical considerations: According to Finnish legislation, no ethical review was needed for this type of questionnaire study. Formal research approvals were obtained from all five hospitals. Return of the questionnaire was interpreted as consent to participate. Results: Ethical climate was perceived as positive. Although morally distressing situations were assessed as highly disturbing, in general they occurred quite rarely. The situations that did appear often reflected performing procedures on school-aged children who resist such treatment, inadequate staffing and lack of time. Perceptions of ethical climate and frequencies of morally distressing situations were inversely correlated. Discussion: Although the results echo the recurrent testimonies of busy work shifts, nurses could most often practise nursing the way they perceived as right. One possible explanation could be the competent and supportive co-workers, as peer support has been described as helpful in mitigating moral distress. Conclusion: Nurturing good collegial relationships and developing manageable workloads could reduce moral distress among nurses. (shrink)

This article aims to foreground alcohol abuse by cancer patients and explore how alcohol abuse functions as a biographic master motive and at the same time is a shadow side in the oncological field and research. The research is based on a single case study which draws on empirical material from interviews, field notes and staff policy, with analysis using Bourdieu’s concepts of trajectory of life and habitus. The findings show that the cancer patient’s alcohol abuse is an important part (...) of the trajectory of his private life and spare time. In social life with family and friends alcohol is given and normal and acts as a socialisator. Alcohol abuse provides both stability and instability in the cancer patient’s life. When cancer results in work breaks and retirement, and spare time often is used as drinking time, then all daily life becomes drinking time for the cancer patient. Alcohol is often a hidden abuse at the working place and in the oncological field. In meetings with healthcare professionals, the patient chooses not to speak about his alcohol abuse to avoid further medicalisation. The challenge for the healthcare professionals is to see and accept alcohol abusers with cancer and their social lives without always trying to change their ‘unhealthy’ lifestyles. (shrink)

Unrealistic optimism is a bias that leads people to believe, with respect to a specific event or hazard, that they are more likely to experience positive outcomes and/or less likely to experience negative outcomes than similar others. The phenomenon has been seen in a range of health-related contexts—including when prospective participants are presented with the risks and benefits of participating in a clinical trial. In order to test for the prevalence of unrealistic optimism among participants of early-phase oncology trials, (...) we conducted a survey with patients over 18 years of age who were enrolled in a phase I, phase I/II, or phase II clinical cancer trial in the New York City area between August 2008 and October 2009. Participants in our study were asked to compare their own chances of experiencing a range of risks and benefits related to the trial they were enrolled in with the chances of the other trial participants. We found a significant optimistic bias in their responses. Respondents tended to overestimate the benefits of the trial they were enrolled in and underestimate its risks. In addition, we found no significant relationship between respondents’ understanding of the trial’s purpose and how susceptible they were to unrealistic optimism. Our findings suggest that improving the consent process for oncology studies requires more than addressing deficits in understanding. (shrink)

One of the difficulties nurses experience in clinical practice in relation to ethical issues in connection with young oncology patients is moral distress. In this descriptive correlational study, the Moral Distress Scale-Paediatric Version (MDS-PV) was translated from the original language and tested on a conventional sample of nurses working in paediatric oncology and haematology wards, in six north paediatric hospitals of Italy. 13.7% of the total respondents claimed that they had changed unit or hospital due to moral distress. (...) The items with the highest mean intensity in the sample were almost all connected with medical and nursing competence and have considerably higher values than frequency. The instrument was found to be reliable. The results confirmed the validity of the MDS-PV (Cronbach’s alpha = 0.959). This study represents the first small-scale attempt to validate MDS-PV for use in paediatric oncology-ematology nurses in Italy. (shrink)

BackgroundIn cancer care, do not resuscitate orders are common in the terminal phase of the illness, which implies that the responsible physician in advance decides that in case of a cardiac arrest neither basic nor advanced Coronary Pulmonary Rescue should be performed. Swedish regulations prescribe that DNR decisions should be made by the responsible physician, preferably in co-operation with members of the team. If possible, the patient should consent, and significant others should be informed of the decision. Previous studies have (...) shown that physicians and nurses can experience ethical dilemmas in relation to DNR decisions, but knowledge about what ethical reasoning they perform is lacking. Therefore, the aim was to describe and explore what ethical reasoning physicians and nurses apply in relation to DNR-decisions in oncology and hematology care.MethodsA qualitative, descriptive and explorative design was used, based on 287 free-text comments in a study-specific questionnaire, answered by 216 physicians and nurses working in 16 oncology and hematology wards in Sweden. Comments were given by 89 participants.ResultsThe participants applied a situation-based ethical reasoning in relation to DNR-decisions. The reasons given for this were both deontological and utilitarian in kind. Also, expressions of care ethics were found in the material. Universal rules or guidelines were seen as problematic. Concerning the importance of the subject, nurses to a higher extent underlined the importance of discussing DNR-situations, while physicians described DNR-decisions as over-investigated and not such a big issue in their daily work.ConclusionThe study revealed that DNR-decisions in oncology and hematology care gave rise to ethical considerations. Important ethical values described by the participants were to avoid doing harm and to secure a peaceful and “natural” death with dignity for their dying patients. A preference for the expression “allow for natural death” instead of the traditional term “do not resuscitate” was found in the material. (shrink)

How should doctors respond to requests from parents of terminally ill children for unproven treatments to be tried? Here it is argued that doctors faced with difficult cases where (1) it is not obviously against a child's interests to undergo an unproven treatment and (2) provided the treatment does not draw extravagantly on NHS funds, it may be appropriate, though not necessarily obligatory, for doctors to comply. It is important to recognise that often there may not be 'the right response'--only (...) alternative appropriate responses. (shrink)

Ethical issues in biomedical research are traditionally examined as distinct from those of clinical care. However, this traditional framing may obscure questions of equity and fairness in both rese...

Inequities in access to oncology care among Indigenous peoples in Canada are well documented. Access to oncology care is mediated by a range of factors; however, emerging evidence suggests that healthcare providers, including nurses, play a significant role in shaping healthcare access. The purpose of this study was to critically examine access to oncology care among Indigenous peoples in Canada from the perspective of oncology nurses. Guided by postcolonial theoretical perspectives, interpretive descriptive and critical discourse analysis (...) methodologies informed study design and data analysis. Oncology nurses were recruited from across Canada to complete an online survey (n = 78). Nurses identified a range of barriers experienced by Indigenous peoples when accessing oncology care, yet located these barriers primarily at the individual and systems levels. Nurses perceived themselves as mediators of access to oncology care; however, their efforts to facilitate access to care were constrained by the dominance of biomedicine within healthcare. Nurses' constructions of access to oncology care highlight the embedded narrative of individualism within nursing practice and the relative invisibility of racism as a determinant of equitable access to care among Indigenous peoples. This suggests a need for oncology nurses to better understand and incorporate structural determinants of health perspectives. (shrink)

DNR decisions are frequently made in oncology and hematology care and physicians and nurses may face related ethical dilemmas. Ethics is considered a basic competence in health care and can be understood as a capacity to handle a task that involves an ethical dilemma in an adequate, ethically responsible manner. One model of ethical competence for healthcare staff includes three main aspects: being, doing and knowing, suggesting that ethical competence requires abilities of character, action and knowledge. Ethical competence can (...) be developed through experience, communication and education, and a supportive environment is necessary for maintaining a high ethical competence. The aim of the present study was to investigate how nurses and physicians in oncology and hematology care understand the concept of ethical competence in order to make, or be involved in, DNR decisions and how such skills can be learned and developed. A further aim was to investigate the role of guidelines in relation to the development of ethical competence in DNR decisions. Individual interviews were conducted with fifteen nurses and sixteen physicians. The interviews were analyzed using thematic content analysis. Physicians and nurses in the study reflected on their ethical competence in relation to DNR decisions, on what it should comprise and how it could be developed. The ethical competence described by the respondents related to the concepts being, doing and knowing. In order to make ethically sound DNR decisions in oncology and hematology care, physicians and nurses need to develop appropriate virtues, improve their knowledge of ethical theories and relevant clinical guidelines. Ethical competence also includes the ability to act upon ethical judgements. Continued ethical education and discussions for further development of a common ethical language and a good ethical working climate can improve ethical competence and help nurses and physicians cooperate better with regard to patients in relation to DNR decisions, in their efforts to act in the best interest of the patient. (shrink)

Transoral laser microsurgery applies to the piecemeal removal of malignant tumours of the upper aerodigestive tract using the CO2 laser under the operating microscope. This method of surgery is being increasingly popularised as a single modality treatment of choice in early laryngeal cancers (T1 and T2) and occasionally in the more advanced forms of the disease (T3 and T4), predomi- nantly within the supraglottis. Thomas Kuhn, the American physicist turned philosopher and historian of science, coined the phrase ‘paradigm shift’ in (...) his groundbreaking book The Structure of Scientific Revolutions. He argued that the arrival of the new and often incompatible idea forms the core of a new paradigm, the birth of an entirely new way of thinking. This article discusses whether Steiner and col- leagues truly brought about a paradigm shift in oncological surgery. By rejecting the principle of en block resection and by replacing it with the belief that not only is it oncologically safe to cut through the substance of the tumour but in doing so one can actually achieve better results, Steiner was able to truly revolutionise the man- agement of laryngeal cancer. Even though within this article the repercussions of his insight are limited to the upper aerodigestive tract oncological surgery, his willingness to question other peoples’ dogma makes his contribution truly a genuine paradigm shift. (shrink)

IntroductionA symptom cluster is very common among oncological patients: cancer-related fatigue, emotional distress, sleep difficulties, pain, and cognitive difficulties. Clinical applications of interventions based on non-ordinary states of consciousness, mostly hypnosis and meditation, are starting to be investigated in oncology settings. They revealed encouraging results in terms of improvements of these symptoms. However, these studies often focused on breast cancer patients, with methodological limitations. Another non-ordinary state of consciousness may also have therapeutic applications in oncology: self-induced cognitive trance. (...) It seems to differ from hypnosis and meditation, as it involves the body more directly. Thus, investigating its clinical applications, along with hypnosis and meditation interventions, could improve available therapeutic options in oncology. This article details the study protocol of a preference-based longitudinal controlled superiority trial aiming to assess the effectiveness of 3 group interventions to improve oncological patients’ quality of life, and more specifically CRF, emotional distress, sleep, pain, and cognitive difficulties.Methods and analysisA power analysis required a total sample of 160 patients. Main inclusion criteria are: cancer diagnosis, active treatments completed for less than a year, no practice of hypnosis, meditation, or SICT, and presence of at least one of these four symptoms: fatigue, sleep difficulties, depression, or anxiety. Each participant will choose the intervention in which they want to participate. To test the effectiveness of the interventions, data will be collected by questionnaires and neurobiological measures and directly from the medical record at four time points: before inclusion in the study ; immediately after the intervention; and at 3- and 12-month follow-up. The longitudinal data in each group will then be measured.DiscussionIn addition to standard cancer therapies, there is a growing interest from patients in complementary approaches, such as hypnosis, meditation, and SICT. The results of this study will be useful to increase knowledge about short- and long-term effectiveness of 3 group interventions for CRF, emotional distress, sleep, pain, and cognitive difficulties in patients with different cancers.Clinical Trial RegistrationClinicalTrials.gov/. Retrospectively registered on the 29th of April 2021. url: https://clinicaltrials.gov/ct2/show/NCT04873661. (shrink)

Patient-derived xenografts are currently promoted as new translational models in precision oncology. PDXs are immunodeficient mice with human tumors that are used as surrogate models to represent specific types of cancer. By accounting for the genetic heterogeneity of cancer tumors, PDXs are hoped to provide more clinically relevant results in preclinical research. Further, in the function of so-called “mouse avatars”, PDXs are hoped to allow for patient-specific drug testing in real-time. This paper examines the circulation of knowledge and bodily (...) material across the species boundary of human and personalized mouse model, historically as well as in contemporary practices. PDXs raise interesting questions about the relation between animal model and human patient, and about the capacity of hybrid or interspecies models to close existing translational gaps. We highlight that the translational potential of PDXs not only depends on representational matching of model and target, but also on temporal alignment between model development and practical uses. Aside from the importance of ensuring temporal stability of human tumors in a murine body, the mouse avatar concept rests on the possibility of aligning the temporal horizons of the clinic and the lab. We examine strategies to address temporal challenges, including cryopreservation and biobanking, as well as attempts to speed up translation through modification and use of faster developing organisms. We discuss how featured model virtues change with precision oncology, and contend that temporality is a model feature that deserves more philosophical attention. (shrink)

The goal is to present how shared decision-making in paediatric oncology occurs from the viewpoints of parents and physicians. Eight Swiss Pediatric Oncology Group centres participated in this prospective study. The sample comprised a parent and physician of the minor patient. Surveys were statistically analysed by comparing physicians’ and parents’ perspectives and by evaluating factors associated with children’s actual involvement. Perspectives of ninety-one parents and twenty physicians were obtained for 151 children. Results indicate that for six aspects of (...) information provision examined, parents’ and physicians’ perceptions differed. Moreover, parents felt that the children were more competent to understand diagnosis and prognosis, assessed the disease of the children as worse, and reported higher satisfaction with decision-making on the part of the children. A patient’s age and gender predicted involvement. Older children and girls were more likely to be involved. In the decision-making process, parents held a less active role than they actually wanted. Physicians should take measures to ensure that provided information is understood correctly. Furthermore, they should work towards creating awareness for systematic differences between parents and physicians with respect to the perception of the child, the disease, and shared decision-making. (shrink)

Novel precision oncology trial designs, such as basket and umbrella trials, are designed to test new anticancer agents in more effective and affordable ways. However, they present some ethical concerns referred to scientific validity, risk-benefit balance and informed consent. Our aim is to discuss these issues in basket and umbrella trials, giving examples of two ongoing cancer trials: NCI-MATCH (National Cancer Institute – Molecular Analysis for Therapy Choice) and Lung-MAP (Lung Cancer Master Protocol) study. We discuss three ethical requirements (...) for clinical trials which may be challenged in basket and umbrella trial designs. Firstly, we consider scientific validity. Thanks to the new trial designs, patients with rare malignancies have the opportunity to be enrolled and benefit from the trial, but due to insufficient accrual, the trial may generate clinically insignificant findings. Inadequate sample size in study arms and the use of surrogate endpoints may result in a drug approval without confirmed efficacy. Moreover, complexity, limited quality and availability of tumor samples may not only introduce bias and result in unreliable and unrepresentative findings, but also can potentially harm patients and assign them to an inappropriate therapy arm. Secondly, we refer to benefits and risks. Novel clinical trials can gain important knowledge on the variety of tumors, which can be used in future trials to develop effective therapies. However, they offer limited direct benefits to patients. All potential participants must wait about 2 weeks for the results of the genetic screening, which may be stressful and produce anxiety. The enrollment of patients whose tumors harbor multiple mutations in treatments matching a single mutation may be controversial. As to informed consent – the third requirement we discuss, the excessive use of phrases like “personalized medicine”, “tailored therapy” or “precision oncology” might be misleading and cause personal convictions that the study protocol is designed to fulfill the individual health-related needs of participants. We suggest that further approaches should be implemented to enhance scientific validity, reduce misunderstandings and risks, thus maximizing the benefits to society and to trial participants. (shrink)

Multiple groups, including the National Bioethics Advisory Commission, the American Society of Clinical Oncology, the National Coalition of Comprehensive Cancer Centers, Workgroup 6 of the Summit Series on Cancer, PRIM&R, the Bell Report, and prominent ethicists have called for replacing the current system of local institutional review with central review for multisite national trials. We argue that this need is particularly acute in pediatric oncology, as shown by the experience of the Children's Oncology Group.