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.

Outcomes of comprehensive geriatric assessment and surgical management in head and neck cancers of the elderly: an observational study.

AIM: The aims of this study were to assess the survival benefit of optimal vs suboptimal management in elderly patients presenting with upper aerodigestive tract (UADT) cancer for which surgery was the standard of care, and determine if comprehensive geriatric assessment (CGA) was a prognostic factor for survival. MATERIALS AND METHODS: This single-center retrospective cohort study was conducted from January 2014 to December 2018. Included patients were aged 70 or older at the time of diagnosis, and presented with UADT cancer with a theoretical indication for curative-intent surgery according to international guidelines. RESULTS: A total of 188 patients were included, with a median age of 78 years. Treatment included surgery in 67.6% of cases and was considered optimal in 60.6% of patients. The overall 3-year survival was 55.2%, and was significantly better in case of optimal vs suboptimal treatment (74.5% vs 25.8%, p < 0.001). In univariate analysis, factors associated with a significantly improved 3-year survival included surgery (p < 0.001), age < 80 years, performance status < 2 and G8 score > 14. In multivariate analysis, CGA was associated with a better survival. CONCLUSIONS: In patients aged over 70 presenting with UADT cancer for which the standard of care is surgery, an optimal management is associated with better overall survival. Receiving a CGA seems to provide a survival benefit in patients with a G8 score ≤ 14, through an optimization of the care pathway before and after the cancer treatment.

Health status of prevalent cancer cases as measured by mortality dynamics (cancer vs. noncancer): Application to five major cancers sites.

BACKGROUND: Cancer prevalence is heterogeneous because it includes individuals who are undergoing initial treatment and those who are in remission, experiencing relapse, or cured. The proposed statistical approach describes the health status of this group by estimating the probabilities of death among prevalent cases. The application concerns colorectal, lung, breast, and prostate cancers and melanoma in France in 2017. METHODS: Excess mortality was used to estimate the probabilities of death from cancer and other causes. RESULTS: For the studied cancers, most deaths from cancer occurred during the first 5 years after diagnosis. The probability of death from cancer decreased with increasing time since diagnosis except for breast cancer, for which it remained relatively stable. The time beyond which the probability of death from cancer became lower than that from other causes depended on age and cancer site: for colorectal cancer, it was 6 years after diagnosis for women (7 years for men) aged 75-84 and 20 years for women (18 years for men) aged 45-54 years, whereas cancer was the major cause of death for women younger than 75 years whatever the time since diagnosis for breast and for all patients younger than 75 years for lung cancer. In contrast, deaths from other causes were more frequent in all the patients older than 75 years. Apart from breast cancer in women younger than 55 years and lung cancer in women older than 55 years and men older than 65 years, the probability of death from cancer among prevalent cases fell below 1%, with varying times since diagnosis. CONCLUSIONS: The authors' approach can be used to better describe the burden of cancer by estimating outcomes in prevalent cases.

Treatment time interval in breast cancer: A population-based study on the impact of type and number of cancer centres attended.

OBJECTIVES: We studied both the independent and combined effects of the places of biopsy and treatment on the treatment time interval based on a population-based study. METHODS: We analysed the proportion of patients having a treatment time interval higher than the EUSOMA recommendation of 6 weeks, as a function of the number and the type of care centres the patients attended, from a French population-based regional cohort of women treated in 2015 for an incident invasive non-metastatic cancer (n = 505). RESULTS: About 33% [95% CI: 27; 38] of patients had a treatment time interval higher than 6 weeks. About 48% of the patients underwent their biopsy and their initial treatment in the different centres. Results from multivariable analyses supported the impact of the type and number of centres attended on the proportion of time intervals over 6 weeks. This proportion was higher among patients with biopsy and treatment in different centres and among patients treated in a university hospital. CONCLUSION: We pointed out the independent impact of the type and the number of care centres the patients attended, from biopsy to first treatment, on the treatment time interval, which is a well-known prognosis factor.

Evaluation of long-term living conditions in patients treated for localised prostate cancer.

PURPOSE: To evaluate the evolution of living conditions (LC) in long-term survivors of localised prostate cancer 10 years after treatment compared with those of a same-age control group from the general population. METHODS: Two hundred and eighty-seven patients diagnosed with prostate cancer in 2001 were selected in 11 French cancer registries. They were matched with controls randomly selected for age and residency. Both patients and controls completed a self-administered LC questionnaire concerning their familial, social and professional life, and general and specific quality of life (QoL) and anxiety and depression questionnaires. RESULTS: Compared with controls, patients reported more sexual modifications (p < .0001), but without any difference in marital status. Patients' circle of friends was more stable than that of the controls (91% vs. 63%; p < .0001) and patients reported fewer friendship modifications than controls (p < .0006). Their professional and physical activities were also preserved. They reported more anxiolytic intake (p = .002) but did not consult their general practitioner more often. Type of specialist consulted differed in the two groups. CONCLUSION: Patients treated for localised prostate cancer had the same living conditions as men of the same age. Their social life was satisfying on the whole, albeit they reported more sexual difficulties than their counterparts.

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.

Improving communication between the general practitioner and the oncologist: a key role in coordinating care for patients suffering from cancer.

BACKGROUND: Patients suffering from cancers are increasingly numerous in general practice consultations. The General Practitioner (GP) should be at the heart of the management of patients. Several studies have examined the perceptions of GPs confronted with the patient suffering from cancer and the relationships of GPs with oncologists, but few studies have focused on the patients' perspective. We studied the three-way relationship between the oncologist, the GP, and the patient, from the patient's point of view. METHODS: A questionnaire validated by a group consisting of GPs, oncologists, nurses, an epidemiologist and quality analyst, was administered over a three-week period to patients suffering from cancer receiving chemotherapy in a day hospital. RESULTS: The analysis was based on 403 questionnaires. Patients had confidence in the GP's knowledge of oncology in 88% of cases; 49% consulted their GP for pain, 15% for cancer-related advice, and 44% in emergencies. Perceived good GP/oncologist communication led patients to turn increasingly to their GP for cancer-related consultations (RR = 1.14; p = 0.01) and gave patients confidence in the GP's ability to manage cancer-related problems (RR = 1.30; p < 0.01). Mention by the oncologist of the GP's role increased the consultations for complications (RR = 1.82; p < 0.01) as well as recourse to the GP in an emergency (RR = 1.35; p < 0.01). CONCLUSION: Patients suffering from cancer considered that the GP was competent, but did not often consult their GP for cancer-related problems. There is a discrepancy between patients' beliefs and their behaviour. When the oncologist spoke to patients of the GP's role, patients had recourse to their GP more often. Systematically integrating a GP consultation to conclude cancer diagnosis disclosure, could improve management and care coordination.

Inventory of tools for care coordination between general practice and hospital system for patients suffering from cancer in active phase of treatment: A scoping review.

INTRODUCTION: During the active phase of treatment, major difficulties appear in the transmission and quality of the information communicated to the General Practitioner (GP). Our objective was to carry out an inventory of the coordination tools used to improve exchanges between the hospital and the GP in the management of the patient suffering from cancer during this phase. MATERIAL AND METHOD: A scoping review was conducted using MEDLINE databases via PubMed, The Cochrane Library, Web of Science. Articles published between 1998 and 2018, in English and French, were analysed. RESULTS: Over 4,863 articles were extracted, and 11 studies were included. They highlight an increase in the quality of patient care after the introduction of information sheets or training by video vignettes with GPs. They demonstrate the importance of using standardised letters between health professionals. The role of a "leader physician" is discussed, and its first evaluations are positive. An increase in information transmitted to GPs leads to a better satisfaction of patients and GPs. CONCLUSION: Communication tools are essential for the transmission of information, but direct and oral communication between all health professionals seems to be a point to be further developed.

Using ecological socioeconomic position (SEP) measures to deal with sample bias introduced by incomplete individual-level measures: inequalities in breast cancer stage at diagnosis as an example.

BACKGROUND: When studying the influence of socioeconomic position (SEP) on health from data where individual-level SEP measures may be missing, ecological measures of SEP may prove helpful. In this paper, we illustrate the best use of ecological-level measures of SEP to deal with incomplete individual level data. To do this we have taken the example of a study examining the relationship between SEP and breast cancer (BC) stage at diagnosis. METHODS: Using population based-registry data, all women over 18 years newly diagnosed with a primary BC in 2007 were included. We compared the association between advanced stage at diagnosis and individual SEP containing missing data with an ecological level SEP measure without missing data. We used three modelling strategies, 1/ based on patients with complete data for individual-SEP (n = 1218), or 2/ on all patients (n = 1644) using an ecological-level SEP as proxy for individual SEP and 3/ individual-SEP after imputation of missing data using an ecological-level SEP. RESULTS: The results obtained from these models demonstrate that selection bias was introduced in the sample where only patients with complete individual SEP were included. This bias is redressed by using ecological-level SEP to impute missing data for individual SEP on all patients. Such a strategy helps to avoid an ecological bias due to the use of aggregated data to infer to individual level. CONCLUSION: When individual data are incomplete, we demonstrate the usefulness of an ecological index to assess and redress potential selection bias by using it to impute missing individual SEP.

Current impact of age and comorbidity assessment on prostate cancer treatment choice and over/undertreatment risk.

PURPOSE: We evaluated the influence of age and comorbidity (Charlson score assessment) on localized prostate cancer therapeutic management and the risk of prostate cancer over- and under-treatment. METHODS: Among the 2571 prostate cancer cases diagnosed in 2011, a subset of 633 patients was randomly selected from the prospectively accrued cohort of the Regional Cancer Registry, among the 17 participating institutions. Treatment distributions were examined for patients at each individual prostate cancer risk, age and comorbidity level and analyzed by multivariate logistic regression analysis. RESULTS: Treatments with curative intent were observed less often when age increased (p < 0.001). We found no impact of the Charlson score on the selection of a curative treatment [HR 0.89, 95 % CI (0.70-1.15)]. A 20 % overtreatment rate was reported in low-risk prostate cancer patients. For younger patients (65-75 years) with high comorbidity score, a 14 % overtreatment rate was observed. Conversely, a 16 % undertreatment rate was reported in older patients >75 years without any significant comorbidity. CONCLUSION: A better consideration of comorbidities could significantly reduce overtreatment in patients <75 year and promote curative treatment in aggressive prostate cancer for older patients without any significant comorbidity.

Assessment of the ecological bias of seven aggregate social deprivation indices.

BACKGROUND: In aggregate studies, ecological indices are used to study the influence of socioeconomic status on health. Their main limitation is ecological bias. This study assesses the misclassification of individual socioeconomic status in seven ecological indices. METHODS: Individual socioeconomic data for a random sample of 10,000 persons came from periodic health examinations conducted in 2006 in 11 French departments. Geographical data came from the 2007 census at the lowest geographical level available in France. The Receiver Operating Characteristics (ROC) curves, the areas under the curves (AUC) for each individual variable, and the distribution of deprived and non-deprived persons in quintiles of each aggregate score were analyzed. RESULTS: The aggregate indices studied are quite good "proxies" for individual deprivation (AUC close to 0.7), and they have similar performance. The indices are more efficient at measuring individual income than education or occupational category and are suitable for measuring of deprivation but not affluence. CONCLUSIONS: The study inventoried the aggregate indices available in France and evaluated their assessment of individual SES.

Are disparities of waiting times for breast cancer care related to socio-economic factors? A regional population-based study (France).

The increasing number of breast cancer cases may induce longer waiting times (WT), which can be a source of anxiety for patients and may play a role in survival. The aim of this study was to examine the factors, in particular socio-economic factors, related to treatment delays. Using French Cancer Registry databases and self-administered questionnaires, we included 1,152 women with invasive non-metastatic breast cancer diagnosed in 2007. Poisson regression analysis was used to identify WTs' influencing factors. For 973 women who had a malignant tissue sampling, the median of overall WT between the first imaging procedure and the first treatment was 44 days (9 days for pathological diagnostic WT and 31 days for treatment WT). The medical factors mostly explained inequalities in WTs. Socio-economic and behavioral factors had a limited impact on WTs except for social support which appeared to be a key point. Better identifying the factors associated with increase in WTs will make it possible to develop further interventional or prospective studies to confirm their causal role in delay and at last reduce disparities in breast cancer management.

Trends in the risk of second primary cancer among bladder cancer survivors: a population-based cohort of 10 047 patients.

OBJECTIVES: To determine whether the risk of second primary cancer (SPC) among patients with bladder cancer (BCa) has changed over past years. MATERIALS AND METHODS: Data from 10 French population-based cancer registries were used to establish a cohort of 10 047 patients diagnosed with a first invasive (≥T1) BCa between 1989 and 2004 and followed up until 2007. An SPC was defined as the first subsequent primary cancer occurring at least 2 months after a BCa diagnosis. Standardized incidence ratios (SIRs) of metachronous SPC were calculated. Multivariate Poisson regression models were used to assess the direct effect of the year of BCa diagnosis on the risk of SPC. RESULTS: The risk of new malignancy among BCa survivors was 60% higher than in the general population (SIR 1.60, 95% confidence interval [CI] 1.51-1.68). Male patients presented a high risk of SPC of the lung (SIR 3.12), head and neck (SIR 2.19) and prostate (SIR 1.54). In multivariate analyses adjusted for gender, age at diagnosis and follow-up, a significant increase in the risk of SPC of the lung was observed over the calendar year of BCa diagnosis (P for linear trend 0.010), with an SIR increasing by 3.7% for each year (95% CI 0.9-6.6%); however, no particular trend was observed regarding the risk of SPC of the head and neck (P = 0.596) or the prostate (P = 0.518). CONCLUSIONS: As the risk of SPC of the lung increased between 1989 and 2004, this study contributes more evidence to support the promotion of tobacco smoking cessation interventions among patients with BCa.

Risk of second primary cancer after a first potentially-human papillomavirus-related cancer: A population-based study.

Human papillomaviruses (HPV) are involved in the development of anogenital and head and neck cancers. The purpose of this study was to assess the risk of developing a second primary cancer (SPC) after a first potentially-HPV-related cancer, and to analyze the sites where SPCs most frequently occurred in these patients. All patients with a first cancer diagnosed between 1989 and 2004, as recorded by 10 French cancer registries, were followed up until December 31, 2007. Only invasive potentially-HPV-related cancers (namely, cervical, vagina, vulva, anal canal, penile, oropharynx, tongue and tonsil) were included. Standardized Incidence Ratios (SIRs) were calculated to assess the risk of SPC. A multivariate Poisson regression model was used to model SIRs separately by gender, adjusted for the characteristics of the first cancer. 10,127 patients presented a first potentially-HPV-related cancer. The overall SIR was 2.48 (95% CI, 2.34-2.63). The SIR was 3.59 (95% CI, 3.33-3.86) and 1.61 (95% CI, 1.46-1.78) in men and women respectively. The relative risk of potentially-HPV-related SPC was high among these patients (SIR=13.74; 95% CI, 8.80-20.45 and 6.78; 95% CI, 4.61-9.63 for men and women, respectively). Women diagnosed in the most recent period (2000-2004) showed a 40% increase of their relative risk of SPC as compared with women diagnosed between 1989 and 1994 (ratio of SIRs=1.40; 95% CI, 1.06-1.85). HPV cancer survivors face an increased risk of SPC, especially second cancer. Clinicians may consider this increased risk of developing HPV-related SPC during follow-up to improve subsequent cancer prevention in these patients.

Primary care physicians and oncologists are partners in cancer announcement.

PURPOSE: The primary care physician (PCP) is central to cancer patients' management. Announcement of the diagnosis is a critical time for patients, even if they wish to be fully informed. The French National Cancer Plan, developed 10 years ago, includes a diagnosis disclosure procedure (DDP) to be used by oncologists, which makes specific provision for a time of communication with PCPs. So, we asked PCPs about their role in cancer announcement since the launching of the DDP. METHODS: A cross-sectional prospective study by postal questionnaire was sent to 500 PCPs in the largest region of France. It addressed (1) the characteristics of cancer disclosure, (2) PCPs' source of information of the diagnosis, (3) time of disclosure, (4) information exchange, and (5) the physicians' knowledge of the DDP. RESULTS: The response rate was 48 %. In 20 % of cases, oncologists delegated the announcement to PCPs. In 19 % of cases, it was the patient or their family who informed the PCP of the diagnosis. We identified three announcement phases of cancer diagnosis in the physicians' clinical practice: pre-disclosure, disclosure, and repeat disclosure. In 57 % of cases, PCPs lacked information on prognosis and in 60 % on treatment. Regarding the DDP, nearly half of PCPs did not know the procedure itself or its content. CONCLUSION: PCPs announce the cancer diagnosis, even if they have not received the necessary information to do so. The DDP needs to be adapted for use in primary care practice.

Total and partial cancer prevalence in the adult French population in 2008.

BACKGROUND: To provide estimations of partial and total prevalence of 24 cancer sites in France in 2008. The estimations of partial prevalence were compared with the previous estimations for 2002. METHODS: Nationwide estimations of incidence and survival data from cancer registries were used for partial prevalence. Nationwide incidence and mortality data were used to estimate total prevalence. RESULTS: At the end of 2008, in France, nearly 3 million people still alive had received a diagnosis of cancer. Of all prevalent cases, 36% were diagnosed 0 to 5 years earlier and 43% diagnosed 6 to 10 years earlier. The cancer sites with the highest prevalence were the prostate, the breast, and the colon-rectum. The changes in partial prevalence over 5 years (2002 to 2008) were considerable (+244,000 cases) and deemed to be highly related to changes in incidence. CONCLUSION: The present estimations update the French prevalence data and highlight the burden of cancer in the population, especially in the elderly. The methods of this study had the advantage of using recent incidence and survival data, which is necessary to show sudden changes in incidence trends and changes in survival that impact prevalence.

Ovarian cancer in France: trends in incidence, mortality and survival, 1980-2012.

OBJECTIVE: The aim of this epidemiological study was to describe the incidence, mortality and survival of ovarian cancer (OC) in France, according to age, period of diagnosis, and histological type. METHODS: Incidence and mortality were estimated from 1980 to 2012 based on data in French cancer registries and from the Centre for Epidemiology of Causes of Death (CépiDc-Inserm) up to 2009. Net survival was estimated from registry data using the Pohar-Perme method, on cases diagnosed between 1989 and 2010, with date of last follow-up set at 30 June 2013. RESULTS: In 2012, 4615 cases of OC were diagnosed in France, and 3140 women died from OC. World population age-standardized incidence and mortality rates declined by respectively 0.6% and 1.2% per year between 1980 and 2012. Net survival at 5years increased slightly, from 40% for the period 1989-1993 to 45% for the period 2005-2010. Net survival varied considerably according to histological type. Germ cell tumors had better net survival at 10years (81%) compared to epithelial tumors (32%), sex cord-stromal tumors (40%) and tumors without biopsy (8%). CONCLUSIONS: Our study shows a decline in incidence and mortality rates from ovarian cancer in France between 1980 and 2012, but net survival remains poor overall, and improved only slightly over the whole study period.

Guideline sheets on the side effects of anticancer drugs are useful for general practitioners.

PURPOSE: General practitioners (GPs) are more and more involved in the treatment of cancer patients but feel not informed enough about anticancer treatments and associated side effects. Better communication with treatment centers is needed. We hypothesized that information sheets could improve communication. METHODS: This prospective, multicentric, and interventionist study aimed at implementing and assessing therapeutic sheets describing the side effects of anticancer drugs used for digestive and gynecological cancers and their recommended management. GPs' phone interviews were done through three successive phases and two independent cohorts. The first phase (T1; 242 GPs with one patient recently treated) listed their expectations, the second (T2; 158 GPs with one patient beginning treatment) assessed the GPs' opinion regarding the sheets, and the third (T3; responder GPs 4 months after the start of T2) assessed their usefulness in practice. RESULTS: In T1, 94% of GPs declared their need of having information sheets, notably for the management of side effects. Thirty-one one-page sheets were created. In T2, 83.5% gave a favorable opinion about sheets and 80% envisaged their use in the case of side effect. In T3, 56% of GPs whose patient had experienced a side effect had used successfully the sheets for its management, and 21% of patients with side effect were hospitalized. A strong correlation existed between the use of the sheet by GPs and the hospitalization (OR 7.35 in the case of no use vs use). CONCLUSION: The guideline sheets represent a simple and low-cost solution to help GPs managing drugs' side effects and perhaps decrease the rate of unplanned hospitalizations.