An Integrated Cancer Prevention Strategy: the Viewpoint of the Leon Berard Comprehensive Cancer Center Lyon, France.

This article describes some of the key prevention services in the Leon Berard Comprehensive Cancer Center (CLB) Lyon, France, which are based on clinical prevention services, outreach activities, and collaboration with professional and territorial health communities. In addition, research is embedded at all stages of the prevention continuum, from understanding cancer causes through to the implementation of prevention interventions during and after cancer. Health promotion activities in the community and dedicated outpatient primary cancer prevention services for individuals at increased risk have been implemented. The CLB's experience illustrates how prevention can be integrated into the comprehensive mission of cancer centers, and how in turn, the cancer centers may contribute to bridging the current fragmentation between cancer care and the different components of primary, secondary, and tertiary prevention. With increasing cancer incidence, the shift toward integrated prevention-centered cancer care is not only key for improving population health, but this may also provide a response to the shortage of hospital staff and overcrowding in cancer services, as well as offer opportunities to reduce carbon emissions from cancer care.

[Shared decision-making: ethical issues]. / Prise de décision partagée : enjeux éthiques.

SHARED DECISION-MAKING: ETHICAL ISSUES. Shared decision-making is a decision-making model and a model of interaction between healthcare professionals and healthcare users. Putting together medical-scientific data, experience, values and preferences of the caregiver on the one hand, and knowledge, needs, expectations, values andpreferences of the patient on the other, leads, if both parties wish so, to a discussion followed by a decision based on a common agreement. Cancer area, either in screening or treatment, in the curative or palliative phase, is well suited to shared decision-making. Shared decision-making is based on ethical principles and classical philosophical streams. Autonomy principle is in the foreground but must not become "an ethical injunction". The relationship between caregiver and patient should recognize above all ability and willingness to participate, or not, in decision-making. Key issues are those of mutual listening, uncertainty recognition and the role of emotions as powerful ethical levers.

PRISE DE DÉCISION PARTAGÉE : ENJEUX ÉTHIQUES. La prise de décision partagée est, parmi d'autres, un modèle d'interaction et de prise de décision entre professionnel de santé et usager du système de santé. La mise en commun des données médico-scientifiques, de l'expérience, des valeurs et préférences du soignant, d'un côté, et des savoirs, besoins, attentes, valeurs et préférences du patient, de l'autre, aboutit, si les deux parties le souhaitent, à une discussion suivie d'une décision prise ensemble et fondée sur un accord commun. La prise en charge du cancer offre un grand nombre de situations propices à ce partage décisionnel, que ce soit pour le dépistage ou le traitement, en phase curative ou palliative. La prise de décision partagée s'appuie sur des principes éthiques et des courants classiques de la philosophie. Mais si elle place au premier plan le principe d'autonomie, celle-ci ne doit pas devenir « une injonction éthique ¼. La relation entre personne malade et soignant reconnaît avant tout la capacité et la volonté de participer, ou non, à la prise de décision. Les enjeux sont ceux de l'écoute réciproque, de la reconnaissance de l'incertitude et du rôle des émotions comme leviers éthiques puissants.

[Facilitators and barriers to shared decision-making in France in 2021: National survey in cancer]. / Leviers et freins à la prise de décision partagée en France en 2021 : enquête nationale auprès des patients atteints de cancer.

INTRODUCTION: Shared-decision making (SDM) combines clinical expertise of the healthcare professional with patient's knowledge, values and preferences. This survey explores from a patient perspective, the implementation, facilitators and barriers of SDM in oncology in France in 2021. PATIENTS AND METHODS: From August to October 2021, the digital platform Cancer contribution conducted an online survey relayed by 11 patient associations. RESULTS: Out of 916 responses, 727 were analyzed: 394 from patients with hematological malignancies [HM], 185 with breast cancer [BC], 93 with other solid tumors [ST] and 55 with multiple cancers [MC]. Among the participants, 47.2 % reported that they participated in a decision about their health management, with a significant variation according to the pathology (BC 43.8 %, HM 41.1 %, ST 57 %, MC 60 %, P=0.01), and regardless of age and gender. Two-thirds felt comfortable with the shared decision-making process, in relation with the time allocated and the information provided, regardless of the pathology. In addition, emotions, uncertainty and lack of information are the main reasons quoted by patients to explain their lack of ease in making a decision related to their health. CONCLUSIONS: In this survey, less than half of the patients declared that they have been enrolled in a SDM approach, this rate varying according to the type of solid tumor or hematological malignancy. This study shows that to improve the implementation of SDM in routine clinical practice in cancer, sufficient time and use of decision aids are needed.

Informing decision makers about public preferences for different modalities of cancer treatment in the Rhône-Alps region in France.

BACKGROUND: Alternative options to hospital care like home care or local health centers (LHCs) are being advocated. However, no study has measured citizens' preferences (who will finance these services via taxation) for these options. OBJECTIVES: We measured (i) citizens' preferences for these services, that is, respondents stated where they would like to get the treatment; (ii) the strength of their preference. METHODS: A computerized survey composed of (i) a decision aid to inform respondents about the three options; (ii) three scenarios, from light-to-heavy care, that respondents should rank from the most to the least preferred option of care. (iii) a contingent valuation survey (CVS) to assess how much respondents were willing to pay for their preferred option (except for hospital care if chosen, because it is the default option and free). (iv) a socio-demographic questionnaire. RESULTS: Data were collected from a representative sample of citizens living in the Rhône-Alps Region (n = 800). The heavier the care was, the more respondents preferred hospital care. Willingness to pay for additional taxation per household/month varied from €13.9 for light care in LHC to €19.1 for heavy home care. The small number of protesting respondents and outliers, and the close correlation between preferences, income, and WTP supports the validity of the CVS. CONCLUSION: In France, for cancer, not all citizens would prefer to be treated at home rather than in a hospital. Only less than a quarter would prefer LHC. These results show the mismatch between public health policies and the citizens' preferences.

Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial.

BACKGROUND: The MyPeBS study is an ongoing randomised controlled trial testing whether a risk-stratified breast cancer screening strategy is non-inferior, or eventually superior, to standard age-based screening at reducing incidence of stage 2 or more cancers. This large European Commission-funded initiative aims to include 85,000 women aged 40 to 70 years, without prior breast cancer and not previously identified at high risk in six countries (Belgium, France, Italy, Israel, Spain, UK). A specific work package within MyPeBS examines psychological, socio-economic and ethical aspects of this new screening strategy. It compares women's reported data and outcomes in both trial arms on the following issues: general anxiety, cancer-related worry, understanding of breast cancer screening strategy and information-seeking behaviour, socio-demographic and economic characteristics, quality of life, risk perception, intention to change health-related behaviours, satisfaction with the trial. METHODS: At inclusion, 3-months, 1-year and 4-years, each woman participating in MyPeBS is asked to fill online questionnaires. Descriptive statistics, bivariate analyses, subgroup comparisons and analysis of variations over time will be performed with appropriate tests to assess differences between arms. Multivariate regression models will allow modelling of different patient reported data and outcomes such as comprehension of the information provided, general anxiety or cancer worry, and information seeking behaviour. In addition, a qualitative study (48 semi-structured interviews conducted in France and in the UK with women randomised in the risk-stratified arm), will help further understand participants' acceptability and comprehension of the trial, and their experience of risk assessment. DISCUSSION: Beyond the scientific and medical objectives of this clinical study, it is critical to acknowledge the consequences of such a paradigm shift for women. Indeed, introducing a risk-based screening relying on individual biological differences also implies addressing non-biological differences (e.g. social status or health literacy) from an ethical perspective, to ensure equal access to healthcare. The results of the present study will facilitate making recommendations on implementation at the end of the trial to accompany any potential change in screening strategy. TRIAL REGISTRATION: Study sponsor: UNICANCER. My personalised breast screening (MyPeBS). CLINICALTRIALS: gov (2018) available at: https://clinicaltrials.gov/ct2/show/NCT03672331 Contact: Cécile VISSAC SABATIER, PhD, + 33 (0)1 73 79 77 58 ext + 330,142,114,293, contact@mypebs.eu.

Implementation of shared decision-making and patient-centered care in France: Towards a wider uptake in 2022.

We present the evolution of patient-centered care (PCC) and shared decision-making (SDM) in France since 2017, highlighting advantages and drawbacks of their implementation at the macro level. We then focus on several key policy and legislative milestones that are aimed to develop PCC and SDM. These milestones underline the importance of patient movements to support and fund the development of research and practice in the field. We shall conclude by presenting the growing research agenda and selected key topics. These key topics notably include the increase in both patient and healthcare professional trainings on PCC and SDM provided by healthcare users' and patients' representatives. PCC and SDM continue to be central preoccupations at the macro level, supported by public health policies and patients/healthcare users' actions. This overview, however, suggests that although implementation initiatives have increased since 2017, implementation remains scarce in routine clinical practice. Funding, not only for research projects, but for the implementation of PCC and SDM in real-life settings (e-decision aids, clinical guidelines integrating PCC/SDM, human resources dedicated to PCC/SDM, etc.) are needed to promote sustained adoption. More systematic training for both healthcare professionals and patients is also warranted for a true acculturation to occur.

Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial.

BACKGROUND: Colorectal cancer (CRC) is a leading cause of cancer burden worldwide. In France, it is the second most common cause of cancer death after lung cancer. Systematic uptake of CRC screening can improve survival rates. However, people with limited health literacy (HL) and lower socioeconomic position rarely participate. Our aim is to assess the impact of an intervention combining HL and CRC screening training for general practitioners (GPs) with a pictorial brochure and video targeting eligible patients, to increase CRC screening and other secondary outcomes, after 1 year, in several underserved geographic areas in France. METHODS: We will use a two-arm multicentric randomized controlled cluster trial with 32 GPs primarily serving underserved populations across four regions in France with 1024 patients recruited. GPs practicing in underserved areas (identified using the European Deprivation Index) will be block-randomized to: 1) a combined intervention (HL and CRC training + brochure and video for eligible patients), or 2) usual care. Patients will be included if they are between 50 and 74 years old, eligible for CRC screening, and present to recruited GPs. The primary outcome is CRC screening uptake after 1 year. Secondary outcomes include increasing knowledge and patient activation. After trial recruitment, we will conduct semi-structured interviews with up to 24 GPs (up to 8 in each region) and up to 48 patients (6 to 12 per region) based on data saturation. We will explore strategies that promote the intervention's sustained use and rapid implementation using Normalization Process Theory. We will follow a community-based participatory research approach throughout the trial. For the analyses, we will adopt a regression framework for all quantitative data. We will also use exploratory mediation analyses. We will analyze all qualitative data using a framework analysis guided by Normalization Process Theory. DISCUSSION: Limited HL and its impact on the general population is a growing public health and policy challenge worldwide. It has received limited attention in France. A combined HL intervention could reduce disparities in CRC screening, increase screening rates among the most vulnerable populations, and increase knowledge and activation (beneficial in the context of repeated screening). TRIAL REGISTRATION: Registry: ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: 2020-A01687-32 . Date of registration: 17th November 2020.

What Works in Implementing Patient Decision Aids in Routine Clinical Settings? A Rapid Realist Review and Update from the International Patient Decision Aid Standards Collaboration.

BACKGROUND: Decades of effectiveness research has established the benefits of using patient decision aids (PtDAs), yet broad clinical implementation has not yet occurred. Evidence to date is mainly derived from highly controlled settings; if clinicians and health care organizations are expected to embed PtDAs as a means to support person-centered care, we need to better understand what this might look like outside of a research setting. AIM: This review was conducted in response to the IPDAS Collaboration's evidence update process, which informs their published standards for PtDA quality and effectiveness. The aim was to develop context-specific program theories that explain why and how PtDAs are successfully implemented in routine healthcare settings. METHODS: Rapid realist review methodology was used to identify articles that could contribute to theory development. We engaged key experts and stakeholders to identify key sources; this was supplemented by electronic database (Medline and CINAHL), gray literature, and forward/backward search strategies. Initial theories were refined to develop realist context-mechanism-outcome configurations, and these were mapped to the Consolidated Framework for Implementation Research. RESULTS: We developed 8 refined theories, using data from 23 implementation studies (29 articles), to describe the mechanisms by which PtDAs become successfully implemented into routine clinical settings. Recommended implementation strategies derived from the program theory include 1) co-production of PtDA content and processes (or local adaptation), 2) training the entire team, 3) preparing and prompting patients to engage, 4) senior-level buy-in, and 5) measuring to improve. CONCLUSIONS: We recommend key strategies that organizations and individuals intending to embed PtDAs routinely can use as a practical guide. Further work is needed to understand the importance of context in the success of different implementation studies.

Cancer care at home or in local health centres versus in hospital: Public policy goals and patients' preferences in the Rhône-Alps region in France.

In France, cancer treatments are mainly provided in hospitals, which are expensive and crowded. Health decision-makers therefore want to develop alternative structures such as home care and local health centres. OBJECTIVES: To elicit cancer patients' preferences for home, local health centre, or hospital, and analyze factors affecting these choices: patients' characteristics, experiences of care, expectations and perceptions of cancer management. METHODS: We developed a decision aid composed of 1) information on the 3 options 2) a questionnaire to measure preferences; 3) a questionnaire on sociodemographics and experiences of care, 386 patients participated in the survey. RESULTS: hospital was the preferred option for 71 % of the participants, especially for complicated care, followed by home care (24 %) and local health centres (5%). Main reasons for preferring hospital were the wish to separate home life and place of care, wanting to avoid being a burden on their relatives. Reasons influencing a preference for home care were wanting to avoid trips, maintain their lifestyle, and finding hospitals frightening. Neither socio-demographics nor even experience of care seemed to explain preferences. CONCLUSION: A quarter of patients preferred home care, which is highly disproportionate to the home care currently available. This suggests that hindrances to developing alternatives to hospital do not come from patients' reluctance to make use of them, but rather from healthcare providers' objections.

Préférences des femmes vis-à-vis du dépistage du cancer du sein.

INTRODUCTION: Over the past decade, the balance between the benefits and harms of breast cancer screening (BCS) has been widely debated. To date, no French study has interrogated women's points of view and preferences (in the economic sense) for this controversial screening. This study aims to bridge this gap. We aimed to elicit women's trade-offs between the benefits and harms of BCS. METHODS: A discrete choice experiment questionnaire was developed and administered by a survey institute to French women in order to elicit their preferences and trade-offs between the benefits and risks of BCS (i.e., overdiagnosis and false-positive mammography). RESULTS: Eight hundred and twelve women, representative of the French general population (age, socioeconomic level, and geographical location), completed the survey. The women would be willing to accept on average 14.1 overdiagnosis cases (median = 9.6) and 47.8 women with a false-positive result (median = 27.2) to avoid one BC-related death. Results from our simulations predict that less than 50% of women would be willing to accept 10 overdiagnosis cases (respectively, 30 women with a false-positive mammography) for one BC-related death avoided. CONCLUSION: Women are sensitive to both the benefits and harms of BC screening and their preferences are highly heterogeneous. Providing balanced information on both benefits and harms to women through an informed decision-making process would be more respectful of women's preferences.

[Eliciting women's preferences for breast cancer screening] / Préférences des femmes vis-à-vis du dépistage du cancer du sein.

INTRODUCTION: Over the past decade, the balance between the benefits and harms of breast cancer screening (BCS) has been widely debated. To date, no French study has interrogated women's points of view and preferences (in the economic sense) for this controversial screening. This study aims to bridge this gap. We aimed to elicit women's trade-offs between the benefits and harms of BCS. METHODS: A discrete choice experiment questionnaire was developed and administered by a survey institute to French women in order to elicit their preferences and trade-offs between the benefits and risks of BCS (i.e., overdiagnosis and false-positive mammography). RESULTS: Eight hundred and twelve women, representative of the French general population (age, socioeconomic level, and geographical location), completed the survey. The women would be willing to accept on average 14.1 overdiagnosis cases (median = 9.6) and 47.8 women with a false-positive result (median = 27.2) to avoid one BC-related death. Results from our simulations predict that less than 50% of women would be willing to accept 10 overdiagnosis cases (respectively, 30 women with a false-positive mammography) for one BC-related death avoided. CONCLUSION: Women are sensitive to both the benefits and harms of BC screening and their preferences are highly heterogeneous. Providing balanced information on both benefits and harms to women through an informed decision-making process would be more respectful of women's preferences.

Women's Benefits and Harms Trade-Offs in Breast Cancer Screening: Results from a Discrete-Choice Experiment.

BACKGROUND: Over the past decade, the benefits and harms balance of breast cancer (BC) screening has been widely debated. OBJECTIVES: To elicit women's trade-offs between the benefits and harms of BC screening and to analyze the main determinants of these trade-offs. METHODS: A discrete-choice experiment with seven attributes depicting BC screening programs including varying levels of BC mortality, overdiagnosis, and false-positive result was used. Eight hundred twelve women aged 40 to 74 years with no personal history of BC recruited by a survey institute and representative of the French general population (age, socioeconomic level, and geographical location) completed the discrete-choice experiment. Preference heterogeneity was investigated using generalized multinomial logit models from which individual trade-offs were derived, and their main determinants were assessed using generalized linear models. Screening acceptance rates under various benefits and harms ratios were simulated on the basis of the distribution of individual preferences. RESULTS: The women would be willing to accept on average 14.1 overdiagnosis cases (median = 9.6) and 47.8 false-positive results (median = 27.2) to avoid one BC-related death. After accounting for preference heterogeneity, less than 50% of women would be willing to accept 10 overdiagnosis cases for one BC-related death avoided. Screening acceptance rates were higher among women with higher socioeconomic level and lower among women with poor health. CONCLUSIONS: Women are sensitive to both the benefits and the harms of BC screening and their preferences are highly heterogeneous. Our study provides useful results for public health authorities and clinicians willing to improve their recommendations of BC screening on the basis of women's preferences.

Moving towards shared decision making in the physician-patient encounter in France: State of the art and future prospects.

In this paper we present the evolution of shared decision making since the mid-nineties in terms of legislation, official statements and guidelines. We outline the goals and declarations of the French Ministry of Health and the French National Authority for Health, for whom informing patients and shared decision-making are central concerns. Finally, we discuss research projects and clinical initiatives in shared decision-making in France and provide a general overview of progress and barriers to progress.

Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group.

Controversies regarding the benefits of breast cancer screening programs have led to the promotion of new strategies taking into account individual preferences, such as decision aid. The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. Women aged 50 to 74 years, were randomly assigned to receive either a decision aid or the usual invitation letter. Primary outcome was the participation rate 12 months after the invitation. 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. The participation rate in the intervention group was 40.25% (3174/7885 women) compared with 42.13% (3353/7959) in the control group (p = 0.02). Previous attendance for screening (RR = 6.24; [95%IC: 5.75-6.77]; p < 0.0001) and medium household income (RR = 1.05; [95%IC: 1.01-1.09]; p = 0.0074) were independently associated with attendance for screening. This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated.

Treatment decision-making in the medical encounter: comparing the attitudes of French surgeons and their patients in breast cancer care.

OBJECTIVES: To explore attitudes of French surgeons and their patients towards treatment decision-making (TDM) in the medical encounter. METHODS: Surgeons involved in early stage breast cancer and their patients treated in a French cancer care network received a cross-sectional survey questionnaire containing examples of four different approaches to TDM: paternalistic, "some sharing", informed TDM and, shared TDM. RESULTS: Surgeons' interaction styles were clearly distributed among paternalistic, shared and mixed. The paternalistic approach seemed to be associated with private rather than public practice and with less professional experience. Patients reported a rather low level of participation in TDM, varying by socio-demographic characteristics. One third of patients were dissatisfied with the way their treatment decision had been made. CONCLUSION: Most surgeons reported adopting the "some sharing" approach. However, one patient out of three reported that they would have liked to participate more in the TDM process. PRACTICE IMPLICATIONS: Surgeons need to ask patients what their preferences for involvement in TDM are and then think about ways to accommodate both their own and patients' preferences regarding the TDM process to be used in each encounter. In addition, decision aids could be offered to surgeons to help them discuss treatment options with their patients.

Heterogeneity of cancer patient information-seeking behaviors.

OBJECTIVES: This study aimed to determine whether cancer patients report different information-seeking behaviors (ISBs), investigate why they searched for information, and determine the relationship between their ISBs and their socioeconomic and behavioral characteristics. The authors also explored the relationship between ISB and participation in the medical decision-making process as well as the patients' health state. METHODS: A sample of 4270 French cancer survivors aged 18 or older was interviewed at 2 years following diagnosis. Rather than deciding a priori who should be considered an information seeker, the authors chose to statistically define the different ISBs using cluster analysis. RESULTS: The authors identified 4 distinct profiles: Stereotypical high-information seekers and acquainted seekers are generally highly educated. They search for information due to their own motivation or because they are close to the medical profession. Constrained information seekers are characterized by a low socioeconomic status. They perceive themselves as "dropouts" of the health care system. Finally, the general information seekers did not systematically resort to any specific ISB. The authors show that after adjustment, belonging to a specific ISB was associated with the likelihood of participating in the medical decision-making process and, more surprisingly, with health state. CONCLUSIONS: A key finding of this study is that social disparities are significantly associated with the different ISBs. If these relationships are found in other samples, it would further support the need for medical teams to pay more attention to patients with lower levels of education, particularly in health care systems that have acknowledged equality as a founding principle. The clusters determined in this study offer a potential theoretical framework that can be used in future studies.

How can continuing professional development better promote shared decision-making? Perspectives from an international collaboration.

BACKGROUND: Shared decision-making is not widely implemented in healthcare. We aimed to set a research agenda about promoting shared decision-making through continuing professional development. METHODS: Thirty-six participants met for two days. RESULTS: Participants suggested ways to improve an environmental scan that had inventoried 53 shared decision-making training programs from 14 countries. Their proposed research agenda included reaching an international consensus on shared decision-making competencies and creating a framework for accrediting continuing professional development initiatives in shared decision-making. CONCLUSIONS: Variability in shared decision-making training programs showcases the need for quality assurance frameworks.

Shared decision making in the physician-patient encounter in France: a general overview in 2011.

WHAT ABOUT POLICY REGARDING SDM? There is a social demand in France for more healthcare user information and greater patient participation in the decision making process, as reflected by the law of March 4(th) 2002 pertaining to patients' rights and the quality of the healthcare system known as the Law on Democracy in healthcare. WHAT ABOUT TOOLS - DECISION SUPPORT FOR PATIENTS? At the micro level, some research projects are being developed, some of them using decision aids. Preliminary results show that patients want to be informed but that the concept of shared decision making needs to be analysed and refined from both the patients' and the physicians' points of views. WHAT ABOUT PROFESSIONAL INTEREST AND IMPLEMENTATION? However, the relationship between physicians/healthcare professionals and patients/healthcare users is very complex and progress in this field takes time. Only ten years after enactment of the Law on Democracy in healthcare, it might be premature to try and determine the state of the art of shared medical decision making at the macro and meso levels in France. WHAT DOES THE FUTURE LOOK LIKE? There is room in France for further studies on shared decision making in the medical encounter. Researchers, decision makers, healthcare users and healthcare professionals need a place to meet and exchange. An observatory dedicated to shared decision making will be launched in the coming months, both at the national level and in collaboration with several other French-speaking areas like Switzerland and the province of Quebec.