Impact of COVID-19 Pandemic on Men Who Have Sex With Men That Practice Chemsex in France: Results From the National ERAS Web Survey.

Chemsex-the use of drugs in a sexual context-has been associated with more at-risk sexual practices and substance-related complications in men who have sex with men (MSM). To date, no study has focused on the impact of France's first coronavirus disease 2019 (COVID-19)-related lockdown on the mental health and drug/alcohol use of MSM who practice chemsex. We implemented a web-based survey of 9,488 MSM living in France in June 2020 (after the country's first COVID-19 lockdown). Specifically, we first compared the subpopulation of MSM who self-reported practicing chemsex during their most recent sexual intercourse (defined as "chemsexers") with other MSM, using five outcomes: increased 1/tobacco use, 2/alcohol use, and 3/other psychoactive drug use. 4/using psychotropic medication during the lockdown, and finally 5/psychological distress. We then analyzed the outcomes' associations with the main explanatory variable "chemsexer," after adjusting for all relevant variables. Among 7,195 MSM who had sexual intercourse with a man during the previous 6 months, 359 participants (5%) were identified as "chemsexers." Multivariable analyses showed that during the first lockdown period, chemsexers were significantly more likely than non-chemsexers to have increased their use of tobacco, alcohol, and other psychoactive substances. Chemsexers were also more likely to have used psychotropic medication and to have experienced psychological distress during the previous month. Given the ongoing COVID-19 pandemic in France and worldwide, this finding highlights the need to develop psychosocial interventions and harm reduction services for MSM chemsexers, potentially via mobile health.

Impact of HIV risk perception on both pre-exposure prophylaxis and condom use.

Risk perception is one of the several important factors impacting sexual health behaviours. This study investigated the evolution of HIV risk perception on pre-exposure prophylaxis adherence and condom use in men who have sex with men at high risk of HIV and associated factors. Group-based trajectory modelling helped in identifying patterns of risk perception, pre-exposure prophylaxis adherence and condom use over time. The association between the former and the latter two dimensions was then investigated. An estimated 61 per cent (p < 0.001) of participants perceiving low risk and 100 per cent (p < 0.001) of those perceiving high risk had systematic pre-exposure prophylaxis adherence, while an estimated 49 per cent (p < 0.001) and 99.8 per cent (p < 0.001), respectively, reported low-level condom use.

Characterization of Physicians That Might Be Reluctant to Propose HIV Cure-Related Clinical Trials with Treatment Interruption to Their Patients? The ANRS-APSEC Study.

HIV cure-related clinical trials (HCRCT) with analytical antiretroviral treatment interruptions (ATIs) have become unavoidable. However, the limited benefits for participants and the risk of HIV transmission during ATI might negatively impact physicians' motivations to propose HCRCT to patients. Between October 2016 and March 2017, 164 French HIV physicians were asked about their level of agreement with four viewpoints regarding HCRCT. A reluctance score was derived from their answers and factors associated with reluctance identified. Results showed the highest reluctance to propose HCRCT was among physicians with a less research-orientated professional activity, those not informing themselves about cure trials through scientific literature, and those who participated in trials because their department head asked them. Physicians' perceptions of the impact of HIV on their patients' lives were also associated with their motivation to propose HCRCT: those who considered that living with HIV means living with a secret were more motivated, while those worrying about the negative impact on person living with HIV's professional lives were more reluctant. Our study highlighted the need to design a HCRCT that minimizes constraints for participants and for continuous training programs to help physicians keep up-to-date with recent advances in HIV cure research.

Changes in Sexual Behaviors in Men Who Have Sex with Men: A Comparison Between the Double-Blind and Open-Label Extension Phases of the ANRS-IPERGAY Trial.

Pre-Exposure Prophylaxis (PrEP) is changing the landscape of HIV prevention, and may bring changes in sexual behaviors. The double-blind phase (DBP) and open-label extension (OLE) study of the ANRS-IPERGAY trial allowed us to assess changes in sexual behavior of men who have sex with men (MSM) taking sexual activity-based (i.e., on-demand) PrEP. Generalized Estimating Equation (GEE) models found a significant decrease in the number of sexual partners (Coefficient [CI95%], p value; - 0.37[- 0.70 to - 0.04], p = 0.03) between the DBP and OLE as well as in the number of sexual relations (- 0.25 [- 0.49 to 0.00], 0.04). GEE estimates also showed that respondents' most recent sexual relation was less likely to have been with an unknown casual partner during the OLE than during the DBP (Odds Ratio [CI95%], p value: 0.75[0.62-0.92], 0.005). Furthermore, they showed an increase in the proportion of condomless anal sex in the OLE (1.32[1.04-1.67], 0.02), a decrease in the proportion of 'suboptimal PrEP adherence' over time (0.75[0.58-0.97], p = 0.03), a decrease in PrEP only use (0.73[0.55-0.96], 0.03) and in both PrEP and condom use over time (0.70[0.51-0.95], 0.02) and finally, a decrease in alcohol consumption between the DBP and OLE (0.74[0.61-0.90], 0.002). We observed both protective and risky behaviors in terms of HIV and STI risk after on-demand PrEP uptake in the OLE phase. Our findings are consistent with results from previous PrEP trials.

Who are the persons living with HIV who might refuse to participate in HIV cure-related clinical trials with treatment interruption?

: Achieving a HIV cure has become a research priority. As any improvement of knowledge, which could help scientists design new HIV cure-related clinical trials (HCRCT) depends on the risks potential participants are willing to accept, it is important to understand who will agree or refuse to participate and in which proportions. By providing insights into factors associated with reluctance toward HCRCT participation, our results may help clinicians in patient recruitment.

What are the situational and behavioral factors associated with condomless anal sex without pre-exposure prophylaxis in MSM?

OBJECTIVE: This study aimed to identify situational and behavioral factors associated with condomless anal sex without on-demand PrEP in the open-label extension (OLE) study of the ANRS-IPERGAY trial. METHODS: Univariable and multivariable modified Poisson regressions with a generalized estimating equation (GEE) were used. The attributable risk percentage for each explanatory variable and for condomless anal sex without PrEP was calculated. RESULTS: In the OLE, 19% of anal intercourses were unprotected (i.e. no PrEP or condom). Of these, 85% were attributable to sexual intercourse with main partners and 47% with HIV-negative partners. The following factors were positively associated with condomless anal sex without PrEP: a depressive episode in the previous 12 months [aR (95% CI), P-value: 1.49 (1.02--2.17), 0.039], a higher number of sexual intercourses during the previous 4 weeks [1.01 [1.002--1.02], 0.014], and sexual intercourses under the influence of alcohol [1.45 (1.10--1.92), 0.008]. By contrast, condomless anal sex without PrEP was less frequent during sexual intercourses with known casual, unknown casual and multiple partners [0.20 (0.14--0.30), <0.001; 0.10 (0.05--0.20), <0.001; 0.11 (0.05--0.29), <0.001, respectively], as well as with HIV+ partners with an undetectable viral load and HIV+ partners with a detectable/unknown viral load or unknown serology status [0.57 (0.38--0.86), 0.007; 0.52 (0.32--0.87), 0.012, respectively]. CONCLUSION: Choosing to have condomless anal sex without PrEP depends primarily on the sexual partner's characteristics (level of intimacy, serological status). This reflects a form of rationality in HIV risk management. However, our results raise questions about the true efficacy of managing HIV risk using this approach.

Differences in HIV cure clinical trial preferences of French people living with HIV and physicians in the ANRS-APSEC study: a discrete choice experiment.

INTRODUCTION: Despite the advent of HIV cure-related clinical trials (HCRCT) for people living with HIV (PLWH), the risks and uncertainty involved raise ethical issues. Although research has provided insights into the levers and barriers to PLWH and physicians' participation in these trials, no information exists about stakeholders' preferences for HCRCT attributes, about the different ways PLWH and physicians value future HCRCT, or about how personal characteristics affect these preferences. The results from the present study will inform researchers' decisions about the most suitable HCRCT strategies to implement, and help them ensure ethical recruitment and well-designed informed consent. METHODS: Between October 2016 and March 2017, a discrete choice experiment was conducted among 195 virally controlled PLWH and 160 physicians from 24 French HIV centres. Profiles within each group, based on individual characteristics, were obtained using hierarchical clustering. Trade-offs between five HCRCT attributes (trial duration, consultation frequency, moderate (digestive disorders, flu-type syndrome, fatigue) and severe (allergy, infections, risk of cancer) side effects (SE), outcomes) and utilities associated with four HCRCT candidates (latency reactivation, immunotherapy, gene therapy and a combination of latency reactivation and immunotherapy), were estimated using a mixed logit model. RESULTS: Apart from severe SE - the most decisive attribute in both groups - PLWH and physicians made different trade-offs between HCRCT attributes, the latter being more concerned about outcomes, the former about the burden of participation (consultation frequency and moderate SE). These different trades-offs resulted in differences in preferences regarding the four candidate HCRCT. PLWH significantly preferred immunotherapy, whereas physicians preferred immunotherapy and combined therapy. Despite the heterogeneity of characteristics within the PLWH and physician profiles, results show some homogeneity in trade-offs and utilities regarding HCRCT. CONCLUSIONS: Severe SE, not outcomes, was the most decisive attribute determining future HCRCT participation. Particular attention should be paid to providing clear information, in particular on severe SE, to potential participants. Immunotherapy would appear to be the best HCRCT candidate for both PLWH and physicians. However, if the risk of cancer could be avoided, gene therapy would become the preferred strategy for the latter and the second choice for the former.

What is the effect of self-identified HIV activism in willingness to participate in HIV cure-related clinical trials? Results from the ANRS-APSEC study.

OBJECTIVES: Enrolling people living with HIV with undetectable viral load into HIV cure-related clinical trials (HCRCT) is challenging. Few data are currently available about the individual factors that influence willingness to participate in HCRCT (WPHCRCT). We hypothesised that WPHCRCT would be more frequent among people living with HIV considering themselves HIV activists. The objective of this study was to investigate the individual characteristics associated with both WPHCRCT and self-identification as an HIV activist. METHODS: The study enrolled 195 long-term ART-treated and virologically suppressed people living with HIV, followed-up in 19 French HIV services, 2016-2017. A Bayesian model averaging approach was used to assess correlates of both outcomes i.e. WPHCRCT and self-identified HIV activism. RESULTS: WPHCRCT was reported by 43% of participants and was positively associated with self-identification as an HIV activist (adjusted odds ratio [aOR] 2.90 95% confidence interval [CI] 2.17-3.63], P<0.05) and self-confidence as an HIV positive person (aOR 1.17, 95% CI 0.99-1.35, P<0.1). Self-identified HIV activists (56% of participants) were more likely to have a higher 'relationship with others' score using the post-traumatic growth inventory (aOR 1.10, 95% CI 0.99-1.20, P<0.1), to obtain information about HIV from a greater number of sources (aOR 1.35 [95% CI 1.00-1.68], P<0.1), and to feel greatly affected by mandatory daily treatment (aOR 2.15, 95% CI 1.27-3.03, P<0.1). All associations had relative importance weight>0.75, indicating strong evidence. CONCLUSIONS: WPHCRCT is strongly related to HIV activism, and also to positive psychosocial characteristics as a person living with HIV, especially regarding relationships with others. The desire to contribute to the fight against HIV for the sake of the HIV community and society should be taken into account to improve participation in upcoming HCRCT.

The ANRS-Ipergay trial, an opportunity to use qualitative research to understand the perception of the "participant"-physician relationship.

The ANRS-IPERGAY trial consisted in providing sexual activity-based antiretroviral prophylaxis for HIV prevention (PrEP) with a package of prevention tools (counselling, condoms, HIV and sexually transmitted infections' screening) to highly exposed HIV-negative men who have sex with men (MSM). Few data exist concerning the patient-physician relationship in the particular context of PrEP, where physicians discuss sexual behaviours with MSM who are not classic patients, in that consultation is for prevention purposes, not for illness. This study took place during the open-label extension of ANRS-IPERGAY trial when all participants received PrEP. In this qualitative study, we examined how physicians perceived their relationship with participants in the ANRS-IPERGAY trial. Of all 30 physicians involved in the trial who were contacted by email to participate in an interview about their opinions and perceptions of ANRS-IPERGAY 18 volunteered to participate in the current sub-study. We performed a vertical analysis for each interview to identify the extract in each physician's discourse concerning their relationship with MSM participants, and conducted a horizontal analysis to construct the thematic tree and subsequently investigate differences and similitudes between themes. An analysis of all physicians' discourses showed that the participant-physician relationship during the trial could be described through 4 themes: (i) personal experience of the relationship, (ii) trust and non-judgement, (iii) positive relational climate and (iv) influence of physician's characteristics (age, gender, etc.) on relationship. We found that the particular context of PrEP led some physicians to adopt a patient-as-partner approach during consultations rather than a paternalist or hierarchical approach. Indeed, the close follow-up provided by the trial and the active role of patients in their own prevention care trajectory, are more compatible with the patient-as-partner approach. The prescription of PrEP may lead to an evolution in patient-physician relationships and may even modify the professional identity of physicians.

Acceptability of HIV cure-related trials: the challenges for physicians and people living with HIV (ANRS-APSEC).

Essential HIV cure-related clinical trials (HCRCT) have a potentially high-risk profile in terms of participants' health, which could hinder enrollment by people living with HIV (PLWH) and healthcare professionals (HP). The ANRS-APSEC survey is part of the IAS "Towards an HIV cure" initiative, which promotes multidisciplinary research for a safe, affordable and scalable cure. The study objectives were to understand the psychosocial mechanisms underlying PLWH and HP viewpoints about future HCRCT. Six focus group discussions (three with PLWH (n = 21) and three with HP (n = 30)) were held in three French infectious disease units. From these, three perspectives on HCRCT were identified. The first involved beliefs and knowledge associating HCRCT with poorer health and quality of life for PLWH. The second concerned perceptions of HCRCT as a biological and epidemiological flashback to a situation when HIV infection was left uncontrolled. The third was characterized by aspects of historical HIV culture that embrace innovation.

Patterns of patient and healthcare provider viewpoints regarding participation in HIV cure-related clinical trials. Findings from a multicentre French survey using Q methodology (ANRS-APSEC).

CONTEXT: Despite huge advances in the fight against HIV concerning diagnosis, clinical efficacy of antiretroviral treatments (ART), patient survival and quality of life, there is still no cure. Recent developments in HIV cure research have opened the way for clinical trials which could lead to a temporary or definitive end to ART. However, ethical questions exist about related trial-participation risks. The main goal of the ANRS-APSEC survey was, using Q-methodology, to investigate the viewpoints of people living with HIV (PLWH) and HIV healthcare providers (HHP) regarding motivations for and barriers to participation in HIV Cure-related clinical trials (HCRCT). MATERIALS AND METHODS: Thirty-three statements were defined encompassing seven dimensions: treatment and follow-up; risks; benefits; patient-physician relationship; beliefs and attitudes; information; target population. Forty-one PLWH and 41 HHP from five French HIV services were asked to rank-order the statements. RESULTS: Five main viewpoints were elicited from "the most motivated" to "the most reluctant" vis-à-vis HCRCT participation. All placed importance on the wish to participate in HIV research. This result is in line with the HIV-specific culture of joint mobilization. For some viewpoints, the motivation to participate in/propose HCRCT was primarily conditioned by side-effects and/or by constraints, which overall were more accepted by PLWH than HHP. Some viewpoints placed particular importance on HCRCT recruitment strategies. Finally, some expressed a high acceptance of risks and constraints but emphasized the need for information. CONCLUSION: HIV cure research clinical trials (HCRCT) constitute a risky yet unavoidable step towards the goal of finding a cure. To improve future HCRCT and informed consent designs, based on PLWH and HHP preferences and expectations, we need greater knowledge about how these populations perceive the risks and the benefits of HCRCT. Our results confirmed the importance of careful, studied HCRCT design, management and communication, to ensure PLWH and HHP acceptability and convergence of their expectations.

Marketing Authorization Procedures for Advanced Cancer Drugs: Exploring the Views of Patients, Oncologists, Healthcare Decision Makers, and Citizens in France.

BACKGROUND: The past decades have seen advances in cancer treatments in terms of toxicity and side effects but progress in the treatment of advanced cancer has been modest. New drugs have emerged improving progression free survival but with little impact on overall survival, raising questions about the criteria on which to base decisions to grant marketing authorizations and about the authorization procedure itself. For decisions to be fair, transparent and accountable, it is necessary to consider the views of those with relevant expertise and experience. METHODS: We conducted a Q-study to explore the views of a range of stakeholders in France, involving: 54 patients (18 months after diagnosis); 50 members of the general population; 27 oncologists; 19 healthcare decision makers; and 2 individuals from the pharmaceutical industry. RESULTS: Three viewpoints emerged, focussing on different dimensions entitled: 1) 'Quality of life (QoL), opportunity cost and participative democracy'; 2)'QoL and patient-centeredness'; and 3) 'Length of life'. Respondents from all groups were associated with each viewpoint, except for healthcare decision makers, who were only associated with the first one. CONCLUSION: Our results highlight plurality in the views of stakeholders, emphasize the need for transparency in decision making processes, and illustrate the importance of a re-evaluation of treatments for all 3 viewpoints. In the context of advanced cancer, our results suggest that QoL should be more prominent amongst authorization criteria, as it is a concern for 2 of the 3 viewpoints.

[Reflections about the efficiency criteria for cancer treatments during marketing authorization application]. / Réflexions sur les critères d'évaluation des traitements anticancéreux lors des procédures d'autorisation de mise sur le marché

Although clear and validated recommendations exist concerning the evaluation of cancer treatments at the international level, the criteria retained to obtain the marketing authorization (MA) are multiple and heterogeneous. This qualitative survey explores the opinion related to the assessment of cancer treatment among the several concerned population. By the way of semi-structured interviews, our aim was to elicit perceptions toward the criteria which should be retained during the process of MA, by patients, oncologists, members of the pharmaceutical industry, health decision-makers and general population. Our survey emphasizes the variability of the significations associated with the criteria of efficiency of cancer treatments according to the characteristics of the respondents. We also have observed some common expectations from patients and oncologists toward the economic and political aspect, but also from the whole respondents toward the importance of the comfort of the patients. Lastly, the necessity to define specific criteria related to clinical cases emerges.

BRCA1/2 carriers: their childbearing plans and theoretical intentions about having preimplantation genetic diagnosis and prenatal diagnosis.

PURPOSE: To assess the impact of BRCA1/2 test results on carriers' reproductive decision-making and the factors determining their theoretical intentions about preimplantation genetic diagnosis (PGD) and prenatal diagnosis (PND). METHODS: Unaffected BRCA1/2 mutation carriers of childbearing age (N = 605; 449 women; 151 men) were included at least 1 year after the disclosure of their test results in a cross-sectional survey nested in a national cohort. Multivariate adjustment was performed on the data obtained in self-administered questionnaires. RESULTS: Response rate was 81.0%. Overall, 32.5% and 50% said that they would undergo PGD/PND, respectively, at a theoretical next pregnancy, whereas only 12.1% found termination of pregnancy (TOP) acceptable. Theoretical intentions toward PGD did not depend on gender/age, but were higher among those with no future childbearing plans (adjusted odds ratio (AOR) 95% confidence interval (CI): 3.5 (1.9-6.4)) and those having fewer relatives with cancer (AOR 1.5 95% CI (1.0-2.3)). Greater TOP acceptability was observed among males and those with lower educational levels; 85.4% of respondents agreed that information about PGD/PND should be systematically delivered with the test results. CONCLUSIONS: The closer to reproductive decision-making BRCA1/2 carriers are, i.e., when they are more likely to be making future reproductive plans, the less frequently they intend to have PGD. Carriers' theoretical intentions toward PND are discussed further.

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.

Prescribers' attitudes toward elderly breast cancer patients. Discrimination or empathy?

Advancing age is often associated with co-morbidities. Patients' chronological and physiological ages do not always correspond. Elderly patients are often excluded from clinical trials and given sub-optimum treatment. In this context, the question of equity in access to health care arises. A specially designed questionnaire was mailed to French oncologists to determine what factors influenced them and to elicit their medical practice using four clinical cases. Significant differences in treatment choice depending only on patient's age were observed. The likelihood of an elderly breast cancer patient undergoing chemotherapy was found to depend on physician specialty and gender, kind of care structure, physician's perception of the age at which patients become elderly, and their knowledge about geriatric assessments. Some physicians did not always prescribe potentially beneficial treatments when dealing with elderly patients. Given the multidimensional nature of the care process, patients' preferences should be taken into account in medical decision-making.

Lung cancer in elderly patients: a retrospective analysis of practice in a single institution.

UNLABELLED: Incidence of non-small cell lung cancer is increasing especially among elderly with about 40% arising in patients over 70 years old. Most of these elderly patients are under treated. Seventy-one patients with lung cancer over 70 years old were treated in Institut Paoli-Calmettes from January 2000 until December 2003 (male/female: 57/14). Median age was 75.5 years (70-92). OMS 0-1-2-3=4.2-60.6-25.4-4.2%, respectively. Comorbidities were represented by arterial hypertension, coronaropathy, cardiac failure, thrombo-embolism, respiratory failure, diabetes, vascular cerebral dysfunction, and renal failure. 29.6% of patients were without comorbidity, and 14.1% had at least three comorbidities. The averages of the Charlson comorbidity score and the Age-Charlson comorbidity score were 3.4 and 6.6, respectively. Histological characteristics: epidermoïd/adenocarcinoma/undifferentiated/small cells: 39.4%/26.8%/15.5%/9.9%. Most of them were advanced lung cancer: St IIIB=14 (19.7%) and St IV=37 (52.1%). Forty-six patients received chemotherapy (64.8%) with 40 patients (86.9%) with platin (carboplatin or cisplatin). The median number of treatment cycles was 4.1 (range 1-7). Two patients achieved complete response and 15 had partial response. The response rate was 39.6%. The 1-year survival rate was 48.5% and the estimated median survival time was 11 months (95%; 7-18 months) for all patients. The 1-year survival rate was 75% and 21.6% and the estimated median survival time was 25.9 months (95%; 12.6, ND) and 5.7 months (95%; 4.2-9.6) for stage IIIB and IV, respectively. Toxicities were judged acceptable with 19 hospitalizations after chemotherapy, for 16 patients who represent 34.8% of patients who received chemotherapy. CONCLUSIONS: Chemotherapy is feasible in elderly patients with lung cancer. Patients should be evaluated for chemotherapy based on their performance status and comorbidities especially with geriatric assessment rather than age alone. The chemotherapy with platinum seems to be tolerable and effective.

The impact of information on non-health attributes on willingness to pay for multiple health care programmes.

Despite the acceptance that health gain is the most important attribute of health care, other aspects of health care may affect utility. The aim of this paper is to report an experiment to test the impact of providing different levels of information in the context of the EuroWill study, a joint contingent valuation (CV) of multiple health programmes. Three hundred and three respondents were simultaneously asked for their willingness-to-pay (WTP) for three health care programmes: more heart operations, a new breast cancer treatment and a helicopter ambulance service. To test for the impact of variation in information, three versions of one of the programmes (heart) were provided. Results show that WTP for all three programmes tended to be significantly higher for respondents who were provided additional positive information about the heart programme. Our results show that CV of health care programmes, which only take into account medical outcomes, may lead to the value of such programmes not being adequately estimated, and that the impact of information may even be more decisive in the context of joint evaluation of multiple, rather than single, programmes.

[Perception of information in through an survey educational booklet on biomedical research oncology: among 129 patients eligible for a clinical trial]. / Perception de l'information à travers une brochure sur la recherche biomédicale en cancérologie : Enquête auprès de 129 patients éligibles pour un essai clinique.

The purpose of this study was to evaluate patients' opinion on the content of an educational booklet (EB) on the objectives of the biomedical research in oncology, and, on the respect of their rights in case of participation to a clinical trial (CT). One hundred and twenty-nine patients treated for cancer at the Institut Paoli-Calmettes (Marseilles, France) and eligible for a CT were included in the study. They received the EB with the information letter and the informed consent sheet related to the CT. After reading, patients completed a survey questionnaire (10 items). About 84% of them stated that the EB content was comprehensible by the majority of patients. However, 18.2% required more information on the different phases of CTs and 39.4% more information on their own treatments. Furthermore, 41.4% were not/not entirely assured that they would receive all the information in case of participation to a CT and about 23% that their rights would be respected. Only 9.6% of patients knew the existence of the local ethical committees (CCPPRB); its intervention (information provided by the EB) was not considered as reassuring by 28.6% of patients. This study has important implications for patients eligible for CTs.