Shared Meditation Involving Cancer Patients, Health Professionals and Third Persons: Perceptions of Participants Through a Focus Group Study.

People with cancer often experience psychological distress and in addition, the practice of oncology is one of the most stressful areas of medicine for health professionals. Mindfulness meditation has been used to alleviate stress-related symptoms. We therefore ran a pilot study to assess the feasibility of a mindfulness intervention involving cancer patients, health professionals, and third persons together, as part of a comprehensive project aiming to evaluate the added value of 'meditating together'. Following on from our quantitative analyses of the project, we investigated its qualitative aspects through focus groups to explore the perceptions of participants regarding their experience. Focus groups conducted in 7 patients, 7 health professionals, and 8 third persons after the intervention showed that 'meditating together' was generally appreciated, particularly by patients, who found it motivating and a way to relieve their feelings of loneliness in the face of illness. All participants reported better stress management. They also shared benefits and difficulties concerning the practice of meditation and the programme's modalities. In addition, they all stated that the programme should be lasting. The opinion of the patients (our target population) will be decisive in building an optimized programme that will suit them the best. In conclusion, the protocol and the qualitative findings of the present study validate the rationale for conducting a fully powered randomized trial to demonstrate the potential added value of shared meditation and how it improves well-being by promoting bridge-building between cancer patients, health professionals and others.Trial Registration: ClinicalTrials.gov. NCT04410185. Registered on June 1, 2020.

How do women comply with cancer screenings? A study in four regions of France.

BACKGROUND: This article looks at the behaviour of women facing different cancer screening options available to them from the age of 50 onward. The study was conducted in 2019 in four departments of the French territory with the objective of identifying the factors that influence acceptance of a population-based screening proposal. METHODS: A questionnaire was sent to women who had received three invitations to organised screenings (OS) for both breast and colorectal cancer. The categories of participants in both OS were designed from data from the regional cancer screening coordination centres in each department. Participation in opportunistic cervical cancer screening was evaluated as self-reported data. RESULTS: 4,634 questionnaires were returned out of the 17,194 sent, giving a global return rate of 27%. The highest rate of return (73.5%) was obtained from women who had participated at least once in both breast and colorectal cancer OS. An intermediate rate was obtained from women participating in breast cancer OS only (18.7%). Poor levels of return came from women who had participated in colorectal cancer OS only (3.6%) and from non-participants (4.1%). Our results suggest that women with lower educational levels tend to be the most regular attendants at OS (50.3%), compared to highly educated women (39.7%). 11.8% of women were overdue in their opportunistic cervical cancer screening. This percentage rose to 35.4% in the category of non-participants. In addition, women's comments provide a better understanding of the reasons for irregular attendance and non-participation. CONCLUSION: Overall, similar behaviours towards screening were observed in the four departments. Our analysis suggests that participation in one cancer OS increases the likelihood of participating in others. This adhesion could be an interesting lever for raising women's awareness of other cancer screenings.

Participation in breast cancer screening and its influence on other cancer screening invitations: study in women aged 56 years old in four French departments.

BACKGROUND: Today, women 50 years of age are offered three types of cancer screening in France. However, participation is not optimal. The aim was to describe (1) participation in organised breast cancer screening (OS) of women aged 56 years old, and the influence of this participation on colorectal and cervical cancer screening, (2) the reasons for non-participation in breast cancer OS, and (3) the reasons for screening before age 50. METHODS: A questionnaire was sent to 56-year-old women in four French departments to identify their participation behaviour in three breast cancer OS invitations and their reasons for non-participation. Three groups were determined according to the number of participations in breast cancer OS (3, 1-2 and 0). We described the quantitative responses and grouped the qualitative responses thematically. RESULTS: A total of 4634 women responded to the questionnaire. Seventy-six percent had undergone all three breast cancer OS, 16% irregular and 7% non-participant. Among women who irregularly perform breast cancer OS, 50.5% also irregularly perform colorectal cancer OS. Women who participated in all three invitations for the breast cancer OS performed more smear tests than women in the other groups. Many of the irregular participants or non-participants underwent opportunistic screening, often initiated before the age of 50. The reasons for non-participation in breast cancer OS were mainly medical or participation in opportunistic screening. CONCLUSION: There is no fundamental opposition to participation in breast cancer screening. However, it remains of the utmost importance that women should be better informed about OS and its benefits.

Termination of pregnancy for foetal indication in the French context analysis of decision-making in a Multidisciplinary Centre For Prenatal Diagnosis.

OBJECTIVE: In France, termination of pregnancy (TOP) for medical reasons is legal, regardless of the term, after authorisation by a Multidisciplinary Centre for Prenatal Diagnosis (MCPD). This study analyses the elements supporting the TOP decision-making process faced with a foetal pathology. STUDY DESIGN: Medical records of one MCPD were analysed for the period 2013 and 2014 and semi-structured interviews with MCPD members were conducted. RESULTS: Out of 265 files concerning foetal indications, all but one resulted in a decision for TOP. The main indications in number for TOP were malformations and chromosomal abnormalities. For indications such as trisomy 21, authorisations are generally given without discussion. Our results underline the importance that professionals attach to the collegiality of decisions, particularly in situations of uncertainty. CONCLUSION: This study provides information about the activity of MCPDs within the field of prenatal diagnosis and shows the importance of these structures in supporting women and couples whilst respecting their autonomy. At present, the role of the MCPD is in the process of evolving and could become an information and advisory board for women, based on collegial expertise to guide their decision-making.

Éthique et dépistages organisés des cancers en France.

Cancer screening has been among the priorities of the French Cancer Plans since 2003. However, participation in screening programs remains below expectations. The predominance of the value of autonomy in today's society may compromise the legitimacy of a public health action if it does not gain the adhesion of individuals. The Group of Reflection on the Ethics of Screening (GRED) set up by the French National Cancer Institute has brought together experts from different disciplines around this issue. The aim of the present article is to summarize the work of the group, which successively focused on breast and colorectal cancer screening programs, followed by reflection on the implementation of organized cervical cancer screening. Information and health education appear to be key levers to enable individuals to understand the collective interest of public health policies and thus to be able to adhere to the proposed actions in an informed manner. This should be made possible by providing complete and high quality information, addressing the limits of each screening including benefits and risks. Valuing the collective dimension of public health, which calls for solidarity, must make it possible to raise awareness of the proper use of public services.

[Ethical considerations in the evolution of organised cancer screening programs]. / Apport de la réflexion éthique dans l'évolution des programmes de dépistage organisé des cancers.

Ethical considerations in the evolution of organised cancer screening programs Since 2009, the French National Cancer Institute has set up a working group on the ethics of screening programs for breast, colon and cervical cancer. Collective and individual interest, equity and respect for autonomy are the values addressed in the respective reports. Ethical analysis has highlighted issues that are specific to each programme: the importance of the information provided by health professionals in a context of uncertainty for breast cancer screening; health professionals as a relay of information, access to test and support in the colorectal cancer screening process and, for cervical cancer screening, the implementation of an organisation adapted to women populations concerned. A public health policy whose efficiency depends on the public's adhesion of screening proposals must respect a fundamental ethical principle, namely the assessment of the benefit/risk balance.

Apport de la réflexion éthique dans l'évolution des programmes de dépistage organisé des cancers Depuis 2009, l'Institut national du cancer a mis en place un groupe de réflexion sur l'éthique des programmes de dépistage des cancers du sein, du côlon et du col de l'utérus. L'intérêt collectif et individuel, l'équité et le respect de l'autonomie sont les valeurs abordées dans les rapports respectifs. L'analyse éthique a fait émerger des enjeux spécifiques à chaque programme : l'importance de l'information délivrée par les professionnels de santé dans un contexte d'incertitude, pour le dépistage du cancer du sein ; les professionnels de santé comme relais d'information, d'accès au test et d'accompagnement dans le parcours de dépistage du cancer colorectal et pour le dépistage du cancer du col de l'utérus, la mise en place d'une organisation adaptée aux populations de femmes concernées. Une politique de santé publique dont l'efficience dépend de l'adhésion de la population aux propositions de dépistage doit respecter un principe éthique fondamental qui est l'évaluation de la balance bénéfices-risques.

Low participation in organized colorectal cancer screening in France: underlying ethical issues.

International studies have shown a significant reduction in colorectal cancer (CRC) mortality following the implementation of organized screening programs, given a sufficient participation rate and adequate follow-up. The French national CRC screening program has been generalized since 2008 and targets 18 million men and women aged 50-74 years. Despite broad recommendations, the participation rate remains low (29.8%), questioning the efficiency of the program. A panel of experts was appointed by the French National Cancer Institute to critically examine the place of autonomy and efficiency in CRC screening and propose recommendations. In this paper, we explore the ethical significance of a public health intervention that falls short of its objectives owing to low take-up by the population targeted. First, we analyze the reasons for the low CRC screening participation. Second, we examine the models that can be proposed for public health actions, reconciling respect for the individual and the collective good. Our expert panel explored possible ways to enhance take-up of CRC screening within the bounds of individual autonomy, adapting awareness campaigns, and new educational approaches that take into account knowledge and analysis of sociocultural hurdles. Although public health actions must be universal, target actions should nonetheless be developed for nonparticipating population subgroups.

[Participation to organized screening programs: Individual and collective stakes]. / Participation aux programmes organisés de dépistage des cancers : enjeu individuel, enjeu collectif.

The evaluation of the risk-benefit balance in public health is an ethical commitment, based on the imperative of not harming people. Screening is a probabilistic approach, which, in order to serve the needs of a few, involves the largest number to share the potential harmful effects. Improvement of scientific knowledge and opening of the societal debate modified the relation between collective and individual stakes over time. This article traces the evolution of the discourse surrounding cancer screening, particularly following the controversy surrounding breast cancer screening. Within the framework of a health policy, screening leads in the first place to a collective benefit and second, to an individual benefit. It describes how, within the French context, the debate has induced a complete re-examination of the modalities of information and consent leading to a shift from the promotion of screening to more balanced information on benefits and risks, so that people can decide whether to participate in a more informed way.

[Ethics of organized cancer screening in France] / Éthique et dépistages organisés des cancers en France.

Cancer screening has been among the priorities of the French Cancer Plans since 2003. However, participation in screening programs remains below expectations. The predominance of the value of autonomy in today's society may compromise the legitimacy of a public health action if it does not gain the adhesion of individuals. The Group of Reflection on the Ethics of Screening (GRED) set up by the French National Cancer Institute has brought together experts from different disciplines around this issue. The aim of the present article is to summarize the work of the group, which successively focused on breast and colorectal cancer screening programs, followed by reflection on the implementation of organized cervical cancer screening. Information and health education appear to be key levers to enable individuals to understand the collective interest of public health policies and thus to be able to adhere to the proposed actions in an informed manner. This should be made possible by providing complete and high quality information, addressing the limits of each screening including benefits and risks. Valuing the collective dimension of public health, which calls for solidarity, must make it possible to raise awareness of the proper use of public services.

Towards equity in organised cancer screening: the case of cervical cancer screening in France.

BACKGROUND: The French national cancer institute (INCa) conducted a series of studies to assist decision-making in view of the implementation of organised cervical cancer screening that will be launched in 2018. The programme will concern all women aged 25-65 and targeted interventions will be developed for underscreened populations. This is an evolution from an equality-based approach to a step-by-step strategy of equity aiming to tackle health cancer inequalities that are avoidable and represents unfair differences. Here we present the work of the expert-group in ethics drafted by INCa to review the ethical issues prior to the programme implementation. DISCUSSION: We discuss the value of such a strategy and presents reflections with regard to issues of stigmatization, respect for individual freedom and autonomy. Indeed, the balance has to be found between the search for beneficence and the potential occurrence of perverse effects, which should be considered with particular attention. CONCLUSION: Moving toward an equity-oriented policy under a strategy of proportionate universalism faces a number of challenges, thus an overview of ethics and social sciences must be an integral part of the process.

[The digital pill, between beneficence and vigilance: ethical stakes]. / Le médicament connecté, entre bienveillance et surveillance - Analyse des enjeux éthiques.

Since November 2017, the digital pill, which makes it possible to know whether a patient has achieved compliance or not with the treatment has become a reality. This drug can benefit the patients by helping them to better follow their treatment and avoid misuse. However, even though the use of this device requests patient consent, major questions arise regarding the respect for privacy and freedom of action. Evidently, the correct use of drugs is both a public health and economic issue, but through this digital tool, the temptation could be to implement measures to control citizens, in particular regarding the use of treatments that affect health expenditure. A too prescriptive conception of monitoring algorithms could alter the care relationship, denying the part of adaptation that a patient can legitimately claim in taking his treatment. The digital pill could be a helpful tool but it is necessary to evaluate its fair place in terms of respect for the person and adequacy with its liberties.

Partnering with patients in translational oncology research: ethical approach.

BACKGROUND: The research program CARPEM (cancer research and personalized medicine) brings together the expertise of researchers and hospital-based oncologists to develop translational research in the context of personalized or "precision" medicine for cancer. There is recognition that patient involvement can help to take into account their needs and priorities in the development of this emerging practice but there is currently no consensus about how this can be achieved. In this study, we developed an empirical ethical research action aiming to improve patient representatives' involvement in the development of the translational research program together with health professionals. The aim is to promote common understanding and sharing of knowledge between all parties and to establish a long-term partnership integrating patient's expectations. METHODS: Two distinct committees were settled in CARPEM: an "Expert Committee", gathering healthcare and research professionals, and a "Patient Committee", gathering patients and patient representatives. A multidisciplinary team trained in medical ethics research ensured communication between the two committees as well as analysis of discussions, minutes and outputs from all stakeholders. RESULTS: The results highlight the efficiency of the transfer of knowledge between interested parties. Patient representatives and professionals were able to identify new ethical challenges and co-elaborate new procedures to gather information and consent forms for adapting to practices and recommendations developed during the process. Moreover, included patient representatives became full partners and participated in the transfer of knowledge to the public via conferences and publications. CONCLUSIONS: Empirical ethical research based on a patient-centered approach could help in establishing a fair model for coordination and support actions during cancer research, striking a balance between the regulatory framework, researcher needs and patient expectations. Our approach addresses the concept of translational ethics as a way to handle the main remaining gap between combining care and research activities in the medical pathway and the existing framework.

Patient/family views on data sharing in rare diseases: study in the European LeukoTreat project.

The purpose of this study was to explore patient and family views on the sharing of their medical data in the context of compiling a European leukodystrophies database. A survey questionnaire was delivered with help from referral centers and the European Leukodystrophies Association, and the questionnaires returned were both quantitatively and qualitatively analyzed. This study found that patients/families were strongly in favor of participating. Patients/families hold great hope and trust in the development of this type of research. They have a strong need for information and transparency on database governance, the conditions framing access to data, all research conducted, partnerships with the pharmaceutical industry, and they also need access to results. Our findings bring ethics-driven arguments for a process combining initial broad consent with ongoing information. On both, we propose key item-deliverables to database participants.

Women's participation in breast cancer screening in France--an ethical approach.

BACKGROUND: Breast cancer is a major public health challenge. Organized mammography screening (OS) is considered one way to reduce breast cancer mortality. EU recommendations prone mass deployment of OS, and back in 2004, France introduced a national OS programme for women aged 50-74 years. However, in 2012, participation rate was still just 52.7%, well short of the targeted 70% objective. In an effort to re-address the (in) efficiency of the programme, the French National Cancer Institute has drafted an expert-group review of the ethical issues surrounding breast cancer mammography screening. DISCUSSION: Prompted by emerging debate over the efficiency of the screening scheme and its allied public information provision, we keynote the experts' report based on analysis of epidemiological data and participation rate from the public health authorities. The low coverage of the OS scheme may be partly explained by the fact that a significant number of women undergo mammography outside OS and thus outside OS criteria. These findings call for further thinking on (i) the ethical principles of beneficence and non-malfeasance underpinning this public health initiative, (ii) the reasons behind women's and professionals' behavior, and (iii) the need to analyze how information provision to women and the doctor-patient relationship need to evolve in response to scientific controversy over the risks and benefits of conducting mammographic screening. SUMMARY: This work calls for a reappraisal of the provision of screening programme information. We advocate a move to integrate the points sparking debate over the efficiency of the screening scheme to guarantee full transparency. The perspective is to strengthen the respect for autonomy allowing women to make an informed choice in their decision on whether or not to participate.

Ethical management in the constitution of a European database for leukodystrophies rare diseases.

BACKGROUND: The EU LeukoTreat program aims to connect, enlarge and improve existing national databases for leukodystrophies (LDs) and other genetic diseases affecting the white matter of the brain. Ethical issues have been placed high on the agenda by pairing the participating LD expert research teams with experts in medical ethics and LD patient families and associations. The overarching goal is to apply core ethics principles to specific project needs and ensure patient rights and protection in research addressing the context of these rare diseases. AIM: This paper looks at how ethical issues were identified and handled at project management level when setting up an ethics committee. METHODS: Through a work performed as a co-construction between health professionals, ethics experts, and patient representatives, we expose the major ethical issues identified. RESULTS: The committee acts as the forum for tackling specific issues tied to data sharing and patient participation: the thin line between care and research, the need for a charter establishing the commitments binding health professionals and the information items to be delivered. Ongoing feedback on the database, including delivering global results in a broad-audience format, emerged as a key recommendation. Information should be available to all patients in the partner countries developing the database and should be scaled to different patient profiles. CONCLUSION: This work led to a number of recommendations for ensuring transparency and optimizing the partnership between scientists and patients.

Severe adult burn survivors. What information about skin allografts?

During the acute phase of a severe burn, surgery is an emergency. In this situation, human skin allografts constitute an effective temporary skin substitute. However, information about the use of human tissue can not be given to the patients because most of the allografted patients are unconscious due to their injury. This study explored the restitution of information on skin donation to patients who have been skin allografted and who have survived their injury. A qualitative study was conducted due to the limited number of patients in ability to be interviewed according to our medical and psychological criteria. 12 patients who had been treated between 2002 and 2008 were interviewed. Our results show that 10 of them ignored that they had received skin allografts. One of the two patients who knew that they had received allografts knew that skin had been harvested from deceased donor. All patients expressed that there is no information that should not be delivered. They also expressed their relief to have had the opportunity to discuss their case and at being informed during their interview. Their own experience impacted their view in favor of organ and tissue donation.

[Multidisciplinary meetings in oncology do not impact the physician-patient relationship]. / La réunion de concertation pluridisciplinaire en cancérologie ne modifie pas la relation entre le médecin et son patient.

CONTEXT: The setting of multidisciplinary meeting (MDM) by the French Cancer Plan has introduced new decisional elements in the patient-physician relationship in oncology. METHODS: To assess the potential impact of MDM on this relationship, a study was conducted at the Tours Hospital: 145 questionnaires were collected from patients whose files have been discussed in MDM, 40 questionnaires were collected from physicians attending these meetings and an analysis of 324 files was performed. RESULTS: Patients recognize the decisional process of MDM as reassuring for 80% of them. However, a majority (73%) expressed that the most important for them is the relationship with the referring physician, almost all (96%) having a total or great confidence in him. The results emphasize that trust appears to be related to the quality of communication, open dialogue and the competence of the doctor in particular in the choice of treatment. A review of files shows that in 91% of cases, the opinion of the RCP is applied and that, in 69% of cases, the referring doctor delivers the information to the patient after MDM. From the physicians' perspective, 33/40 report that the MDM do not alter their relationship with the patient. We note that 35/40 express that the consultation after MDM facilitates the presentation of the decision and 37/40 that the decision is always or often applied in accordance with the opinion of the MDM. CONCLUSION: MDM appears in most cases in this study not to modify the patient-physician relationship. Due to the patient confidence into the referring physician, the role of this one is essential in integrating the decisional multidisciplinary opinion of MDM and it is important to ensure from his/her disengagement in the decisional process.

Information that should be given to HIV cohort participants during ongoing research: the viewpoints of patient representatives and research professionals.

While investigators have a duty to provide research participants with summary findings at the end of a study, providing general information during the course of research is rarely considered. However, this raises an important ethical issue in the context of long-term studies such as cohorts or biobanks. We investigated this issue in the context of two ANRS cohorts of HIV-infected patients, AQUITAINE and COPILOTE. Face-to-face interviews were conducted with HIV patient representatives and research professionals concerning the delivery of information in the course of the research. Respondents stated that participants wish to be informed of research results (both aggregate and individual) but also expect general information about the cohort itself, research progression, and what their participation may provide. It was concluded that information provided during the course of the research may help participants to distinguish between care and research. The essential role of clinicians-investigators in providing information was emphasized.