Ethical Considerations in Chemotherapy and Vaccines in Cancer Patients in Times of the COVID-19 Pandemic.

The COVID-19 situation is a worldwide health emergency with strong implications in clinical oncology. In this viewpoint, we address two crucial dilemmas from the ethical dimension: (1) Is it ethical to postpone or suspend cancer treatments which offer a statistically significant benefit in quality of life and survival in cancer patients during this time of pandemic?; (2) Should we vaccinate cancer patients against COVID-19 if scientific studies have not included this subgroup of patients? Regarding the first question, the best available evidence applied to the ethical principles of Beauchamp and Childress shows that treatments (such as chemotherapy) with clinical benefit are fair and beneficial. Indeed, the suspension or delay of such treatments should be considered malefic. Regarding the second question, applying the doctrine of double-effect, we show that the potential beneficial effect of vaccines in the population with cancer (or those one that has had cancer) is much higher than the potential adverse effects of these vaccines. In addition, there is no better and less harmful known solution.

Decision-making on therapeutic futility in Mexican adolescents with cancer: a qualitative study.

BACKGROUND: The world literature shows that empirical research regarding the process of decision-making when cancer in adolescents is no longer curable has been conducted in High-income, English speaking countries. The objective of the current study was to explore in-depth and to explain the decision-making process from the perspective of Mexican oncologists, parents, and affected adolescents and to identify the ethical principles that guide such decision-making. METHODS: Purposive, qualitative design based on individual, fact-to-face, semi-structured, in-depth interviews. The participants were thirteen paediatric oncologists, 13 parents or primary carers, and six adolescents with incurable cancer. The participants were recruited from the paediatric oncology services of three national tertiary-care medical centres in Mexico City. RESULTS: The oncologists stated that they broach the subject of palliative management when they have determined that curative treatment has failed. Respect for autonomy was understood as the assent of the parent/adolescent to what the oncologist determined to be in the best interest of the adolescent. The oncologists thought that the adolescent should be involved in the decision-making. They also identified the ability to count on a palliative care clinic or service as an urgent need. For the parents, it was essential that the oncologist be truly interested in their adolescent child. The parents did not consider it necessary to inform the child about impending death. The adolescents stated that the honesty of their oncologists was important; however, several of them opted for a passive role in the decision-making process. CONCLUSION: The findings of this study evidence that to achieve good medical practice in low-middle income countries, like Mexico, it is urgent to begin effective implementation of palliative care, together with appropriate training and continuing education in the ethics of clinical practice.

Return and Disclosure of Research Results: Parental Attitudes and Needs Over Time in Pediatric Oncology.

OBJECTIVES: To explore parental attitudes regarding the return and disclosure of research findings in pediatric cancer trials over time. STUDY DESIGN: Two surveys were set up to evaluate the stability of parental attitudes. One survey was carried out among 581 parents whose child was diagnosed recently (response rate, 53.5%). A second, population-based survey was set up with a time interval of 4 years between first cancer diagnosis and survey in which 1465 parents were included (response rate, 55.1%). RESULTS: Almost all surveyed parents stated a parental right to receive aggregate research results. Fifty-five percent of the parents who recently participated in trials and 62% of those asked after a multiyear time interval thought that disclosure of individual findings is in any case necessary (P = .0034). The respondents wanted to restrict the duty to disclose study results to the child according to their notion of the child's well-being, composed of child's maturity, impairment of the parent-child relationship, and the quality of the results. CONCLUSIONS: Attitudes of parents regarding the return of research findings change over time. Shortly after diagnosis, parents are mainly interested in aggregate findings. Interest in individual findings appeared to increase as more time elapsed between cancer diagnosis and survey.

Relationships between oncohematopediatrics, mothers and children in communicating bad news. / Relações entre oncohematopediatras, mães e crianças na comunicação de notícias difíceis.

We present a study about the relations between pediatric oncological haematologists, mothers, and children in sharing bad news (BN) in a public hospital in Rio de Janeiro. The text emphasizes the intertwining of technique and emotions for the treatment of children with diagnoses in which the fatal outcome is always a probability. We used a qualitative approach, privileging participant observation and open interviews with oncologists (at this service all professionals were female) and mothers. We sought to understand the importance of communication which includes expressions and control of emotions; bioethical issues that require sensitivity, serenity, and truth about approaching the end of life; and how the professionals balance proximity to children and families and objectivity in their activity. The main results showed: intense exchanges on BN among professionals; relapse of children who were evolving positively as the most difficult news; constant update of BN facing terminally ill children; quality of communication influencing the treatment; professionals permanently balancing between closeness and distance from patients and evidence of the their irreplaceable role to secure the family and the child.

Relações entre oncohematopediatras, mães e crianças na comunicação de notícias difíceis / Relationships between oncohematopediatrics, mothers and children in communicating bad news

Resumo Apresenta-se um estudo de relações entre oncohematopediatras, mães e crianças no compartilhamento de notícias difíceis (ND) num hospital público do Rio de Janeiro. O texto enfatiza o entrelaçamento de técnica e emoção durante o tratamento de crianças com diagnósticos em que a probabilidade de desfecho fatal está sempre presente. Utilizou-se abordagem qualitativa, privilegiando-se observação participante e entrevistas abertas com as médicas (neste serviço, todas as profissionais eram do sexo feminino) e mães. Buscou-se compreender a importância da comunicação que inclui expressões e controle das emoções; aspectos bioéticos que exigem sensibilidade, serenidade e verdade sobre a aproximação do final da vida; e como as médicas equilibram proximidade com as crianças e familiares e objetividade em sua atuação. Os principais resultados mostram: intensas trocas sobre ND entre as profissionais; recaída de crianças que estavam evoluindo positivamente como a notícia mais difícil; atualização da ND diante dos pacientes terminais; influência da qualidade da comunicação no tratamento; exercicío permanente de equilíbrio entre proximidade e distanciamento por parte das profissionais e evidência do insubstituível papel delas para dar segurança à família e à criança.

Abstract We present a study about the relations between pediatric oncological haematologists, mothers, and children in sharing bad news (BN) in a public hospital in Rio de Janeiro. The text emphasizes the intertwining of technique and emotions for the treatment of children with diagnoses in which the fatal outcome is always a probability. We used a qualitative approach, privileging participant observation and open interviews with oncologists (at this service all professionals were female) and mothers. We sought to understand the importance of communication which includes expressions and control of emotions; bioethical issues that require sensitivity, serenity, and truth about approaching the end of life; and how the professionals balance proximity to children and families and objectivity in their activity. The main results showed: intense exchanges on BN among professionals; relapse of children who were evolving positively as the most difficult news; constant update of BN facing terminally ill children; quality of communication influencing the treatment; professionals permanently balancing between closeness and distance from patients and evidence of the their irreplaceable role to secure the family and the child.

Ethical decision making about end-of-life care issues by pediatric oncologists in economically diverse settings.

PURPOSE: Pediatric cancer represents 1% to 4% of all cancers worldwide, with the majority of diagnoses in developing countries where mortality remains much higher than that in high-income countries. We sought to describe differences in ethical decision-making at the end of life among an international sample of pediatric oncologists practicing in countries with a variety of income levels and resource settings. METHODS: Pediatric oncologists subscribing to an educational international oncology Web site were invited to complete a 38-item web-based survey investigating ethical domains related to end-of-life care: level of care, fiduciary responsibility, decision making, and justice. RESULTS: Responses were received from 401 physicians in 83 countries, with most respondents practicing in middle-income or high-income countries. Significant differences in attitudes toward ethical issues existed across the national developmental indices. CONCLUSIONS: Further education on ethical principles is warranted in pediatric oncology, particularly among oncologists practicing in low-income or middle-income countries.

Information to the patient with cancer: the oncologist's view.

OBJECTIVE: To identify what information is provided to the patients by oncologists, assess what they take into account in the process of informing the patient, and to ascertain whom the information is provided to. METHODS: The study subjects were oncologists recruited among those registered at the Brazilian Society of Clinical Oncology - SBOC. All material was mailed to the Society, which was then forwarded to the participant oncologists. The previously stamped envelopes contained: a questionnaire, the questionnaire instructions, and the informed consent form to be signed. The data obtained was statistically treated, following a 95% confidence interval. RESULTS: 876 questionnaires were sent (total number of physicians registered at SBOC) and a 16.55% response rate was achieved. Regarding the information provided, 81% of the physicians responded they informed patients about diagnosis, treatment and prognosis; however, 73% reported that in most cases the patient is already aware of his/her disease. Nevertheless, the information is provided to the patient and his(her) family by 81% of doctors. Among the relevant aspects in the information process, the patient's gender has little influence on the information for 95% of doctors. CONCLUSION: Considering the results achieved, we conclude that in the study population, physicians are concerned about providing information according to the patient's profile. We could also notice that oncologists try to provide patients with the information they are entitled to - the truth, although they often resort to the family's assistance in providing that information.

Incertidumbre, esperanza y corporalidad en el final de la vida / Uncertainty, hope and embodiment in the end of life

O artigo explora as relações entre corporalidade e incerteza na experiência do pacientes com doenças oncológicas avançadas, atendidos em uma unidade de Cuidados Paliativos da cidade de Buenos Aires, Argentina. A partir de uma abordagem etnográfica, interessa apresentar diferentes formas de interrogar as sensações corporais associadas à doença em contextos de forte incerteza. Primeiro, analisa-se uma forma de hipervigilância do corpo, constituído como espaço onde ler o avance da enfermidade e a morte, ligada à abordagem sintomática dos Cuidados Paliativos e as imagens do caráter expansivo do câncer. Segundo, apresenta-se uma forma de interrogar o corpo em que a experiência da incerteza e projetada em narrativas da esperança. Tentativas, precárias, ameaçantes ou reparadoras, as interpretações que os pacientes fazem de seus signos corporais apresentam tênues variações do saber biomédico, onde a dimensão emocional se revela como central na experiência do padecimento.

This paper works on the experience of uncertainty and embodiment in patients with oncological diseases, who are attended in a Palliative Care Unit of Buenos Aires city, Argentine. Based on an ethnografic approach, we show different ways in which patients interrogate their corporal sensations related to illness experience in contexts of strong uncertainty. First, we explore a way of hipervigilance of the body, where the physical symptoms are interpreted as signs of illness and death. Second, we explore alternative forms of interpreting bodily sensations, related to narratives of hope. Tentative, precarious, threatening or reparative, interpretations that patients make of their corporal signs present subtle variations of biomedical knowdledge, and show central aspects of emotional dimension in the illness experience.

Dialetics of balanced autonomy in disagreements between patients and oncological surgeons.

OBJECTIVE: To comprehend different logics of autonomy that are present in conflicts between surgical prescriptions and the expectations of patients with diagnoses of cancer. METHODOLOGICAL PROCEDURES: This is a qualitative study in which 11 semistructured interviews were conducted with oncological surgeons specializing in head and neck tumors, in the city of Rio de Janeiro, Southeastern Brazil, between 2000 and 2005. The participants were selected by means of chain sampling and the fieldwork was halted in accordance with the criterion of saturation. The discourse analysis technique was used to identify the premises that structured the concept of autonomy and would constitute the discursive dialectics within the context of patients who fight against undergoing surgery that is considered to be of mutilating nature. ANALYSIS OF RESULTS: At first, the surgeons expressed standardized statements centered on deontological concepts of autonomy. As they narrated their experiences, self-questioning that brought out contradictions regarding the routine concept of "informed resectability" was observed. At this point, the standardized discourse became permeated by self-questioning about the need to return to the existential balance that had been harmed by the cancer. CONCLUSIONS: The narratives expressed demands for "balanced autonomy" in the form of a semi-project that is not aprioristically idealizable but is dependent on mutual interactions. The results indicated the need for reflection on the concept of autonomy as a linear, categorical and individual premise that, although superficially elaborated, governs everyday actions.

Disclosure of conflicts of interest by authors of clinical trials and editorials in oncology.

PURPOSE: There is concern that financial relationships between sponsors and investigators may bias research results. Our objective was to evaluate the epidemiology of conflicts of interest (COIs) among authors of clinical trials and editorials in oncology and the relationship between COI disclosure and source of funding. METHODS: We did a cross-sectional survey of clinical trials and editorials of anticancer agents and supportive care medications published in the Journal of Clinical Oncology (JCO) during a 1-year period. RESULTS: Of 1,533 articles published in JCO between January 1, 2005, and January 31, 2006, 332 met our inclusion criteria; 289 (87%) were clinical trials, and 43 (13%) were editorials. The pharmaceutical industry entirely or partially funded 44% of the clinical trials. At least one COI was disclosed in 69% of clinical trials and 51% of editorials. The most common types of COI reported by authors were consultancy fees, honoraria, and research funds. The highest monetary levels of interest reported by authors were for research grants, but the majority of authors with COIs received less than US$10,000. In multivariable analysis, authors of clinical trials conducted in North America (North America v Europe: odds ratio [OR] = 2.9, P = .002) and authors of trials funded entirely (industry only v nonprofit: OR = 13.8, P < .001) or partially (both industry and nonprofit v nonprofit only: OR = 5.8, P < .001) by industry were more likely to report personal COIs. CONCLUSION: COIs are common in clinical cancer research and usually take the form of consultancy fees, honoraria, and research funds. Source of study funding was significantly associated with COI disclosure.

Phase I research and the meaning of direct benefit.

In this article, I examine whether Phase I pediatric oncology trials offer "the prospect of direct benefit," a concept found in Subpart D of the Code of Federal Regulations (CFR), the guidelines that provide additional protections to pediatric research subjects. In research that offers the prospect of direct benefit, children can be exposed to greater risk than in other research and their dissent can be overridden. I argue that Phase I trials do not offer the prospect of direct benefit and classifying them as if they do fails to acknowledge the moral relevance of the researchers' intent. In Subpart D, research that does not provide the prospect of direct benefit can be approved locally if it does not expose the children to more than a minor increase over minimal risk. If the risks are greater, the research must be approved nationally. To avoid the need for national review for Phase I oncology trials, I propose a new research category that incorporates the concept of "secondary direct benefit." In this category, the child's dissent would be dispositive. This new category would improve the protections provided to children by incorporating intentions into Subpart D, the absence of which is a serious flaw in our current regulatory schema.