Increasing access to fertility preservation for women with breast cancer: protocol for a stepped-wedge cluster randomized trial in France.

BACKGROUND: With the increase in the number of long-term survivors, interest is shifting from cancer survival to life and quality of life after cancer. These include consequences of long-term side effects of treatment, such as gonadotoxicity. Fertility preservation is becoming increasingly important in cancer management. International recommendations agree on the need to inform patients prior to treatments about the risk of fertility impairment and refer them to specialized centers to discuss fertility preservation. However, the literature reveals suboptimal access to fertility preservation on an international scale, and particularly in France, making information for patients and oncologists a potential lever for action. Our overall goal is to improve access to fertility preservation consultations for women with breast cancer through the development and evaluation of a combined intervention targeting the access and diffusion of information for these patients and brief training for oncologists. METHODS: Firstly, we will improve existing information tools and create brief training content for oncologists using a qualitative, iterative, user-centred and participatory approach (objective 1). We will then use these tools in a combined intervention to conduct a stepped-wedge cluster randomized trial (objective 2) including 750 women aged 18 to 40 newly treated with chemotherapy for breast cancer at one of the 6 participating centers. As the primary outcome of the trial will be the access to fertility preservation counselling before and after using the combined intervention (brochures and brief training for oncologists), we will compare the rate of fertility preservation consultations between the usual care and intervention phases using linear regression models. Finally, we will analyse our approach using a context-sensitive implementation analysis and provide key elements for transferability to other contexts in France (objective 3). DISCUSSION: We expect to observe an increase in access to fertility preservation consultations as a result of the combined intervention. Particular attention will be paid to the effect of this intervention on socially disadvantaged women, who are known to be at greater risk of inappropriate treatment. The user-centred design principles and participatory approaches used to optimize the acceptability, usability and feasibility of the combined intervention will likely enhance its impact, diffusion and sustainability. TRIAL REGISTRATION: Registry: ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT05989776. Date of registration: 7th September 2023. URL: https://classic. CLINICALTRIALS: gov/ct2/show/NCT05989776 . PROTOCOL VERSION: Manuscript based on study protocol version 2.0, 21st may 2023.

A Comparative Multicenter Cohort Study Evaluating the Long-Term Influence of the Strict Lockdown during the First COVID-19 Wave on Lung Cancer Patients (ARTEMISIA Trial).

The consequences of the strict health restrictions during the first wave of COVID-19 on lung cancer (LC) patients are not known. This cohort study evaluated the impact of the initial lockdown on management of and long-term outcome in LC patients. This exposed-unexposed-type study included two evaluation periods of 6 months each in non-selected patients; one began on the first day of lockdown in 2020, and the other in 2019 during the same calendar period. Various indicators were compared: clinical profiles, management delays and overall survival beyond 2 years. A total of 816 patients from 7 public or private centers were enrolled. The clinical characteristics of the patients in 2020 did not differ from those in 2019, except that the population was older (p = 0.002) with more non-smokers (p = 0.006). Delays for pre-therapeutic medical management were generally reduced after the first imaging in 2020 (1.28 [1.1-1.49]). In the multivariate analysis, being part of the 2020 cohort was correlated with better prognosis (HR = 0.71 [0.5-0.84], p < 0.001). The gain observed in 2020 mainly benefited non-smoking patients, along with ECOG PS 0-2 (p = 0.01), stage 4 (p = 0.003), squamous cell carcinoma (p = 0.03) and receiving systemic therapy (p = 0.03). In conclusion, the first lockdown did not exert any deleterious impact on LC patients.

Quality of advanced ovarian cancer surgery: A French assessment of ESGO quality indicators.

OBJECTIVES: In 2016, the European Society of Gynecology Oncology (ESGO) published indicators defining the quality of surgical management of advanced ovarian cancer. The objective of the study was to assess the quality of ovarian cancer patient management in regional centers authorized for gynecological cancer, based on the ESGO list of quality indicators. METHODS: A multicenter retrospective observational cohort study was conducted from January 1 to June 30, 2016. The following quality indicators 1 "rate of complete surgical resection", 4 "center participating in clinical trials in gynecologic oncology", 5 "treatment planned and reviewed at a multidisciplinary team meeting", 6 "required preoperative workup", 8 "minimum required elements in operative reports" and 9 "minimum required elements in pathology reports" were selected. RESULTS: 91 patients were evaluated in 16 centers. The required preoperative workup was incomplete in 25% of cases. Treatment was not planned at a multidisciplinary team meeting for 24%. An evaluation score of peritoneal involvement was included in 40% of the operative reports and the quality of surgical resection was reported in 72%. Primary surgery was most often performed in a peripheral hospital (48%), interval surgery in a private center (37%), and closure surgery in a regional cancer center (43%). No institution respected the six quality indicators evaluated. One regional cancer center respected five items and two private centers did not respect any. CONCLUSION: Whilst the ESGO quality indicators provide objective, validated and evaluable support which centers can use to improve quality of care, we observed heterogeneous practices amongst the centers evaluated.

[Regional cancers networks, collaborative work in adults and pediatricians]. / Réseaux régionaux en cancérologie, collaboration équipes adulte et pédiatrique.

Regional cancer networks missions have been defined by successive "Plan Cancer" and are focused on coordination and the safety and quality of care. Regional pediatric oncology networks, considering the specific care pathways, have these same coordination missions. The examples of partnership of the oncoped-PL (Pays de Loire) and oncomip (Occitanie) networks are successful collaboration models.

[The monitoring of oral anticancer medicines administered at home]. / Le suivi des thérapies anticancéreuses à domicile.

Anticancer medicines evolve in terms of their mode of action as well as their galenics. The advent of oral therapies has multiple benefits such as the possibility of taking the treatments at home. However, what are the implications with regard to compliance, the management of side effects and the community-hospital relationship? Elderly patients, often isolated, taking several medicines and frail, are disorientated faced with all these medications and their side effects. A study was undertaken to evaluate the benefit of visits by private practice nurses to support patients taking oral cancer drugs.

[Taking into consideration patient concerns for the elaboration of educational programs for chronic renal failure patients]. / Comment intégrer les patients dans l'élaboration de programmes d'éducation thérapeutique dans l'insuffisance rénale chronique ?

The objective was to take into consideration patient concerns for an original qualitative approach to the elaboration of three therapeutic education programs (TEP) designed for chronic renal failure patients, transplantation recipients, and dialysis patients. Four discussion groups involved patients with non-terminal chronic renal failure (one group), transplantation recipients (one group), and dialysis patients (two groups). Topics discussed were patients' knowledge of the TEP and their disease and treatment, patients' expectations concerning the educative content and the organisation of the TEP. For all levels of chronic renal failure, patient expectations focused on nutrition, treatments, and the social and occupational supportive network. Patients with non-terminal renal failure also expressed their expectations concerning the comprehension of laboratory tests and the course of their renal disease. Transplantation recipients wanted to strengthen their knowledge about graft evolution and immunosuppression. Dialysis patients expressed their concerns about disease announcement and the decision for dialysis. While certain topics were common, patients were preoccupied by different problems depending on their degree of renal insufficiency. Nephrolor thus integrated these different levels of concern into the elaboration of E'Dire programs designed for non-terminal renal failure patients and EDUGREFFE for transplant recipients. The third program designed for dialysis patients is currently in the development phase.

Intervention dose estimation in health promotion programmes: a framework and a tool. Application to the diet and physical activity promotion PRALIMAP trial.

BACKGROUND: Although the outcomes of health promotion and prevention programmes may depend on the level of intervention, studies and trials often fail to take it into account. The objective of this work was to develop a framework within which to consider the implementation of interventions, and to propose a tool with which to measure the quantity and the quality of activities, whether planned or not, relevant to the intervention under investigation. The framework and the tool were applied to data from the diet and physical activity promotion PRALIMAP trial. METHODS: A framework allowing for calculation of an intervention dose in any health promotion programme was developed. A literature reviews revealed several relevant concepts that were considered in greater detail by a multidisciplinary working group. A method was devised with which to calculate the dose of intervention planned and that is actually received (programme-driven activities dose), as well as the amount of non-planned intervention (non-programme-driven activities dose). RESULTS: Indicators cover the roles of all those involved (supervisors, anchor personnel as receivers and providers, targets), in each intervention-related groups (IRG: basic setting in which a given intervention is planned by the programme and may differ in implementation level) and for every intervention period. All indicators are described according to two domains (delivery, participation) in two declensions (quantity and quality). Application to PRALIMAP data revealed important inter- and intra-IRG variability in intervention dose. CONCLUSIONS: A literature analysis shows that the terminology in this area is not yet consolidated and that research is ongoing. The present work provides a methodological framework by specifying concepts, by defining new constructs and by developing multiple information synthesis methods which must be introduced from the programme's conception. Application to PRALIMAP underlined the feasibility of measuring the implementation level. The framework and the tool can be used in any complex programme evaluation. The intervention doses obtained could be particularly useful in comparative trials. TRIAL REGISTRATION: PRALIMAP is registered at ClinicalTrials.gov under NCT00814554.

[Therapeutic patient education in health centers in the Lorraine region of France - an EPATEL study]. / Activités d'éducation thérapeutique proposées par les établissements de santé de la Région Lorraine - enquête EPATEL.

The purpose of this paper is to map out the Therapeutic Patient Education activities of health centers in the Lorraine region of France in the months leading up to the promulgation of the HPST law (reform of the French Public Hospital system) defining and regulating TPE. A self-administered survey and interviews were conducted to identify the educational activities offered by the program (structure, training of professionals, links with general practitioners, etc.) and to quantify them (number of patients, classes, etc.). All health centers in Lorraine were contacted (193 centers in total). 93 centers responded and 48?reported TPE activities, with 131 functional TPE courses (or structured activities) and 40 projects. An analysis based on 8 quality criteria was carried out. The study found that 49 centers met at least 6 quality criteria and were close to the required quality standards. The study also found that the geographical distribution of TPE provision is unbalanced. The number of TPE beneficiaries in a given semester varies between 0 and 24 patients per 1,000 inhabitants (according to the health area), which amounts to 5% of chronically ill people in the Lorraine region.

Polymorphonuclear neutrophils from JAK2(V617F) positive MPD patients do not support hypercoagulability: A study with calibrated automated thrombography (CAT).

Essential thrombocythemia and polycythemia vera are myeloproliferative disorders (MPD) with an elevated thrombotic risk. Leukocytosis has recently emerged as a new risk factor and there is increasing evidence that polymorphonuclear neutrophils (PMN) are involved. Procoagulant activity (PCA) of PMN in MPD has not yet been investigated. PCA of PMN from 22 patients with JAK2(V617F) positive MPD and 26 healthy subjects was studied using calibrated automated thrombography: in vitro thrombin generation induced with 1 pM tissue factor in the presence of added procoagulant phospholipids. There were no differences between patients and controls regarding the ability of PMN to increase thrombin generation. More surprisingly, basal thrombin generation in acellular MPD-plasma was found decreased for as yet unknown reasons. The presence of an active protein C pathway or platelets might provide a better insight into the coagulation phenotype in MPD.

Evaluation of peroxidase activity by alpha-naphthol/pyronine staining compared with benzidine staining in 101 acute leukemia cases.

Cytochemical detection of myeloperoxidase (MPO) activity, a strong marker for myeloid differentiation, is usually performed by benzidine dihydrochloride staining, with the threshold at 3%. Several reports have demonstrated the potential toxicity of benzidine, and bans have been issued, under French law, prohibiting female technicians from being exposed to the aromatic hydrocarbon group, including benzidine. The aim of this study was to test an alpha-naphthol and pyronine-based substitute using a standardized kit (MYELOPEROXIDASE KIT, RAL [Réactifs RAL, Martillac, France]) to measure MPO activity in blast cells. This prospective, multicenter study made it possible to analyze 101 acute leukemia (AL) cases; it has also demonstrated both the 96% specificity and the 99% sensitivity of the method, with a threshold for positive staining of 3%, as well as good correlation (r = 0.95) between the staining method tested and the benzidine staining method. When using the alpha-naphthol/pyronine-based staining for MPO, the mean number of positive blast cells is statistically lower than that obtained using benzidine, but without incidence on AL classification. These results allow us to conclude that this method makes it possible to classify acute blood diseases by measuring MPO activity using reagents permitted by law, according to a standardized and reproducible protocol.