From a voluntary vaccination policy to mandatory vaccination against COVID-19 in cancer patients: an empirical and interdisciplinary study in bioethics.

BACKGROUND: At the start of 2021, oncologists lacked the necessary scientific knowledge to adapt their clinical practices optimally when faced with cancer patients refusing or reluctant to be vaccinated against COVID-19, despite the marked vulnerability of these patients to severe, and even fatal forms of this new viral infectious disease. Oncologists at Foch Hospital were confronted with this phenomenon, which was observed worldwide, in both the general population and the population of cancer patients. METHODS: Between April and November 2021, the Ethics and Oncology Departments of Foch Hospital decided to investigate this subject, through an empirical and interdisciplinary study in bioethics. Our scientific objective was to try to identify and resolve the principal bio-ethical issues, with a view to improving clinical practices in oncology during future major pandemics of this kind, from a highly specific bio-ethical standpoint (= quality of life/survival). We used a mainly qualitative methodological approach based on questionnaires and interviews. RESULTS: In April 2021, 29 cancer patients refused or were reluctant to be vaccinated (5.6%; 29/522). Seventeen of these patients said that making vaccination mandatory would have helped them to accept vaccination. In October 2021, only 10 cancer patients continued to maintain their refusal (1.9%; 10/522). One of the main reasons for the decrease in refusals was probably the introduction of the "pass sanitaire" (health pass) in July 2021, which rendered vaccination indispensable for many activities. However, even this was not sufficient to convince these 10 cancer patients. CONCLUSION: We identified a key bio-ethical issue, which we then tried to resolve: vaccination policy. We characterized a major tension between "the recommendation of anti-COVID-19 vaccination" (a new clinical practice) and "free will" (a moral value), and the duty to "protect each other" (a moral standard). Mandatory vaccination, at least in France, could resolve this tension, with positive effects on quality of life (i.e. happiness), or survival, in cancer patients initially refusing or reluctant to be vaccinated, but only if collective and individual scales are clearly distinguished.

Palliative care in day-hospital for advanced cancer patients: a study protocol for a multicentre randomized controlled trial.

BACKGROUND: Team-based and timely integrated palliative care is a gold standard of care in oncology, but issues concerning its optimal organization remain. Palliative Care in Day-Hospital (PCDH) could be one of the most efficient service model of palliative care to deliver interdisciplinary and multidimensional care addressing the complex supportive care needs of patients with advanced cancer. We hypothesize that, compared to conventional outpatient palliative care, PCDH allows the clinical benefits of palliative care to be enhanced. METHODS/DESIGN: This study is a multicentre parallel group trial with stratified randomization. Patient management in PCDH will be compared to conventional outpatient palliative care. The inclusion criteria are advanced cancer patients referred to a palliative care team with an estimated life expectancy of more than 2 months and less than 1 year. The primary endpoint is health-related quality of life with deterioration-free survival based on the EORTC QLQ-C30 questionnaire. The secondary objectives are the following: increase in patient satisfaction with care using the EORTC PATSAT-C33 and OUT-PATSAT7 questionnaires, better understanding of the prognosis using the PTPQ questionnaire and advance care planning; decrease in the need for supportive care among relatives using the SCNS-P&C-F questionnaire, and reduction in end-of-life care aggressiveness. Patients will complete one to five questionnaires on a tablet before each monthly visit over 6 months and will be followed for 1 year. A qualitative study will take place, aiming to understand the specificity of palliative care management in PCDH. Cost-effectiveness, cost-utility and, an additional economic evaluation based on capability approach will be conducted from a societal point of view. DISCUSSION: The first strength of this study is that it combines the main relevant outcomes assessing integrated palliative care; patient quality of life and satisfaction; discussion of the prognosis and advance care planning, family well-being and end-of-life care aggressiveness. The second strength of the study is that it is a mixed-method study associating a qualitative analysis of the specificity of PCDH organization, with a medical-economic study to analyse the cost of care. TRIAL REGISTRATION: Name of the registry: IDRCB 2019-A03116-51 Trial registration number: NCT04604873 Date of registration: October 27, 2020 URL of trial registry record.

[Intellectual disability and cancer in children: An analysis of the decision-making process]. / Déficience intellectuelle et cancer chez l'enfant : analyse des pratiques concernant le choix du traitement.

AIM: The aim was to describe and to analyze the ethics of decision-making in situations involving children with intellectual disability and cancer, from the referent-doctor's point-of-view, in pediatric oncology units in France. METHODS: Pediatricians working in pediatric oncology units were interviewed through an online questionnaire and a semi-directive interview was systematically proposed. We analyzed the ethical issues that arose during the process of decision-making and we made suggestions in order to address them. RESULTS: Sixteen doctors reported twenty-one clinical cases. Of these cases, one third of the children had a change in their oncologic treatment, with a risk of pejorative outcome on the prognosis. Despite the fact that ethical issues appeared in 80 % of the cases, there were few consultations with ethical committees. Decision-making process showed no difference compared to children without intellectual disability, thus raising ethical issues in the medical team. Our study showed discrepancy between frequently reported ethical issues, high consensus rate regarding treatment decision and lack of consultation with ethical committees. DISCUSSION: We propose three steps to guide the decision-making process in situations involving children with intellectual disability and cancer: 1/deeper understanding of the child through reinforced interactions with their caregivers, 2/better cross-boundary discussions, to improve the effectiveness of the multidisciplinary staff, and 3/more systematic ethical committees consultation.

[Experience of care and daily life during national sanitary confinement in patients followed and treated in Cancer Control Centers: The BaroCov Inquiry]. / Expérience des soins et de la vie quotidienne pendant le confinement sanitaire national chez des patients suivis et traités en centre de lutte contre le cancer : l'enquête BaroCov.

Confinement within the framework of Covid 19 required organizations in cancer centers, in particular with postponing certain treatments. We interviewed 6080 patients who had a scheduled appointment during this period. 2478 patients gave their opinion regarding access and organization of care, teleconsultation, their concerns and their reasons for satisfaction. While 83 % of them say they are satisfied with the organization of care, 25 % of respondents say they have given up care that they consider essential in 1/3 of cases. The concern related to the follow-up of the cancerous disease takes precedence over that of being infected with the Sars-cov-2 virus, unlike the general population, and relationships with their loved ones are spontaneously cited as a reason for satisfaction. This method captures the experience of patients, despite certain limitations. Such an approach could be used to set up a specific system during normal periods.

Advanced cancer and COVID-19 comorbidity: medical oncology-palliative medicine ethics meetings in a comprehensive cancer centre.

OBJECTIVES: In managing patients with cancer in the COVID-19 era, clinical oncologists and palliative care practitioners had to face new, disrupting and complex medical situations, challenging the quality of the shared decision-making process. During the first lockdown in France, we developed an onco-palliative ethics meeting to enhance the quality of the decision-making process for patients with advanced cancer treated for COVID-19. METHODS: A least one of the institutional ethics committee members was present along with oncologists, palliative care teams, psycho-oncologists, radiologists and intensive care specialists. Specific medical parameters were systematically collected to form a standardised framework for the discussions. RESULTS: The main raised issues were the definition of new criteria for the implementation of invasive resuscitation techniques, optimal ways to adapt or delay anticancer treatment and best procedures to address terminal respiratory failure and end-of-life care. The main clinical and ethical guidelines that emerged during these debates are presented. The palliative care team played a major role in assessing and reporting patients' awareness of cancer-related prognosis and their wishes concerning invasive therapies or transfer to intensive care units, enabling an individualised benefit-risk balance assessment. The ethics committee members ensured continuous monitoring during the discussions. Their function was to recall the main ethical principles including dignity, which is conferred on people when there are treated as having equal status. CONCLUSIONS: The onco-palliative ethics meeting provided a powerful avenue for improvement of collegiality and reinforcement of teamwork, which could be a major protection against burnout for healthcare professionals facing an epidemic onslaught.

[Adapting to the SARS-CoV2 pandemic: Experience of the Curie Institute]. / S'adapter face à la pandémie SARS-CoV2 : l'expérience de l'Institut Curie.

The Curie Institute exclusively cares for cancer patients, who were considered particularly "vulnerable" from the start of the SARS-CoV 2 pandemic. This pandemic, which took the medical world by surprise, suddenly required the Institute's hospital to undergo rapid and multimodal restructuring, while having an impact on everyone to varying degrees. We will examine here how this hospital has coped, with the concern for a new benefit-risk balance, in times of greater medical uncertainty and scarcity of certain resources, for these "vulnerable" patients but also for their relatives and staff. We will highlight by theme the positive aspects and difficulties encountered, and then what could be useful for other hospitals as the pandemic is ongoing.

[Early palliative care in oncology]. / Les soins palliatifs précoces et intégrés en oncologie.

Early palliative care is now recommended in international guidelines. A meta-analyze combining seven randomized studies has been published in 2007. It confirms that early palliative care improves patient's quality of life and reduces symptom burden. There is also a trend for the reduction of depressive disorder and the increase of overall survival. Other studies show that early palliative care improves quality of life of patient's relatives and reduces end of life care aggressiveness. Most of the time, early palliative care is introduced as soon as the diagnosis of advanced cancer is made, and the precise referral criteria need to be addressed. Other studies have assessed the palliative care consultation; patient-centered care, focusing on symptom management, filling information and education needs about illness and prognosis, helping psychologic adaptation and coping.