Measuring reconceptualization and reprioritization during France's first COVID-19-related lockdown in women with and without a history of cancer: an adaptation of the SeiQol-DW and PGI.

PURPOSE: This study aimed to provide a better understanding of the patient-perceived effects of France's first COVID-19-related lockdown on the quality of life (QoL) of women affected by cancer, and to test an ad hoc measurement scale for evaluating quasi-individualized QoL. QoL was measured for both during (i.e., current) and before (i.e., retrospectively) the lockdown. Respondents were women registered on the research platform Seintinelles. METHODS: A tool for measuring quasi-individualized QoL was adapted from the SeiQol-DW and PGI. It was distributed as part of a larger online self-questionnaire to a sample of 1303 women with a history of cancer (i.e., former or current) and with no such history. RESULTS: Current and retrospective QoL scores were not significantly different between the two respondent groups. An analysis of reconceptualization and reprioritization revealed a cancer-specific effect: women with a history of cancer reconceptualized more, while women with no such history reprioritized more. CONCLUSION: Our novel ad hoc quasi-qualitative tool made it possible to assess the QoL of women with a history of cancer, a particularly vulnerable population in the context of the COVID-19 pandemic. Furthermore, it highlighted a difference in reconceptualization and reprioritization between this population and women with no such history.

Determinants of adherence and consequences of the transition from adolescence to adulthood among young people with severe haemophilia (TRANSHEMO): A multicentric French national observational cross-sectional study based on the FranceCoag registry.

INTRODUCTION: It is necessary to gain insights into adherence to healthcare in people with severe haemophilia (PwSH), especially during the transition from paediatric to adult care, which is an important phase in lives of young people with childhood chronic disease. This adherence can be considered as a marker of successful transition. OBJECTIVES: The main objective of the quantitative phase of the TRANSHEMO project was to compare the adherence to healthcare between adolescents and young adults (YAs) with severe haemophilia. The secondary objective was to identify the determinants (facilitators and barriers) of this adherence and associations between these determinants. METHODS: A multicentre, observational, cross-sectional study was conducted in 2017-2019 on PwSH aged between 14 and 17 years (adolescents) or between 20 and 29 years (YAs), included in the FranceCoag registry and having completed the questionnaires. The adherence to healthcare (treatment regimens and clinical follow-up) was compared between adolescents and YAs using the chi-squared test. The determinants of this adherence were analysed by structural equation modelling. RESULTS: There were 277 participants, 107 adolescents, and 170 YAs. The rate of adolescents adhering to healthcare was 82.2%, while the rate of YAs was 61.2% (p < .001). The barriers to the adherence to healthcare were being YA, having repeated at least one school grade and presenting mental health concerns. CONCLUSION: Adolescents had better adherence to healthcare than YAs. According to the determinants enlightened in this project, targeted supportive strategies and adapted therapeutic education programs can be developed for young PwSH to facilitate their adherence to healthcare.

[Role of emotions and representations in the use of m-health among members of an online cancer-related community, the Seintinelles]. / Rôle des émotions et représentations dans le recours à la m-health chez les membres d'une communauté d'intérêt en ligne en lien avec le cancer, les Seintinelles.

INTRODUCTION: Virtual communities related to cancer, as with other chronic pathologies, seem to constitute a population likely to have a privileged relationship with e-health technologies. However, although many studies have sought to identify the characteristics of e-health users, none has focused specifically on members of health-related virtual communities. The objective is to identify the psychosocial determinants of the use of connected objects and health applications (COAs) among members of an online community of interest in cancer, the Seintinelles. METHODS: Data collection was performed using a self-questionnaire aiming to collect sociodemographic and psychosocial data. RESULTS: Only a minority of participants owned at least one COA. Positive emotions and the perception of COAs as a motivator to take care of one's health favored their adoption. Considering COASs as aimed toward ill people or perceiving them as complex are barriers to their use. DISCUSSION: Participants do not seem to have a privileged relationship with COAs. Reinforcing a sense of self-efficacy and ensuring that mobile devices and health apps elicit positive emotions in potential users is an essential step in facilitating the use of m-health from a health promotion perspective among individuals who are members of such virtual communities related to cancer.

At the heart of the COVID-19 crisis: Perceived concerns of changes in long-term cancer care in French women with cancer.

OBJECTIVE: In the COVID-19 crisis context, the main objective of the study is to investigate factors associated with perceived concerns of change in long-term cancer care in patients currently under treatment. METHODS: A French population-based cross-sectional study was performed using an online questionnaire in April 2020. All persons currently receiving cancer treatment and belonging to the Seintinelles Association (https://www.seintinelles.com) were included in this present analysis. Individual sociodemographic characteristics, medical status and information regarding cancer care were collected. Multivariate binomial logistic regression analysis was performed. RESULTS: We included 298 women in the analysis. Younger participants (OR = 0.96 [0.94-0.99]), the need to visit healthcare facilities to receive treatment (OR = 2.93 [1.16-8.52]), deterioration in the quality of communication with the medical team since the beginning of the COVID-19 crisis (OR = 3.24 [1.61-7.02]) and being cared for by a university hospital or a public hospital (OR = 2.19 [1.16-4.23] versus comprehensive cancer centre) were associated with a perceived fear of change in long-term cancer care. CONCLUSION: To address patients' concerns regarding changes in their long-term cancer care, medical teams should consider the patients' own perceptions of the situation and provide clear, appropriate, precise information on cancer care, especially in the centres mostly affected by the COVID-19 crisis.

Willingness of French General Practitioners to Prescribe mHealth Apps and Devices: Quantitative Study.

BACKGROUND: The field of mobile health (mHealth) is constantly expanding. Integrating mHealth apps and devices in clinical practice is a major and complex challenge. General practitioners (GPs) are an essential link in a patient's care pathway. As they are patients' preferred health care intermediaries, GPs play an important role in supporting patients' transition to mHealth. OBJECTIVE: This study aims to identify the factors associated with the willingness of French GPs to prescribe mHealth apps and devices to their patients. METHODS: This study was part of the ApiAppS project whose overall objective was to help remove barriers GPs face when prescribing mHealth apps and devices by developing a custom-built platform to aid them. The study included GPs recruited from the general practice department of several medical faculties in France (Lyon, Nice, and Rouen) and mailing lists of academic GPs, health care professional associations, and social and professional networks. Participants were asked to complete a web-based questionnaire that collected data on various sociodemographic variables, indicators of their involvement in continued education programs and the amount of time they dedicated to promoting healthy behaviors during patient consultations, and indicators characterizing their patient population. Data on their perceptions of mHealth apps and devices were also collected. Finally, the questionnaire included items to measure GPs' acceptability of prescribing mHealth apps and devices for several health-related dimensions. RESULTS: Of the 174 GPs, 129 (74.1%) declared their willingness to prescribe mHealth apps and devices to their patients. In multivariate analysis, involvement in continued education programs (odds ratio [OR] 6.17, 95% CI 1.52-28.72), a better patient base command of the French language (OR 1.45, 95% CI 1.13-1.88), GP-perceived benefits of mHealth apps and devices for both patients and their medical practice and GP-perceived drivers for mHealth apps and device implementation in their medical practice (OR 1.04, 95% CI 1.01-1.07), and validation of mHealth apps and devices through randomized clinical trials (OR 1.02, 95% CI 1.00-1.04) were all associated with GPs' willingness to prescribe mHealth apps and devices. In contrast, older GPs (OR 0.95, 95% CI 0.91-0.98), female GPs (OR 0.26, 95% CI 0.09-0.69), and those who perceived risks for the patient or their medical practice (OR 0.96, 95% CI 0.94-0.99) were less inclined to prescribe mHealth apps and devices. CONCLUSIONS: mHealth apps and devices were generally seen by GPs as useful in general medicine and were, for the most part, favorable to prescribing them. Their full integration in general medicine will be conditioned by the need for conclusive certification, transparency (reliable and precise data concerning mHealth app and device methods of construction and clinical validation), software aids to assist GPs prescribe them, and dedicated training programs.

Connected device and therapeutic patient education to promote physical activity among women with localised breast cancer (DISCO trial): protocol for a multicentre 2×2 factorial randomised controlled trial.

INTRODUCTION: Despite safety and benefits of physical activity during treatment of localised breast cancer, successful exercise strategies remain to be determined. The primary objective of the 'dispositif connecté', that is, connected device in English trial is to evaluate the efficacy of two 6-month exercise interventions, either single or combined, concomitant to adjuvant treatments, on the physical activity level of patients with breast cancer, compared with usual care: an exercise programme using a connected device (activity tracker, smartphone application, website) and a therapeutic patient education intervention. Secondary objectives are to evaluate adherence to interventions, their impact at 6 and 12 months, representations and acceptability of interventions, and to assess the cost-effectiveness of the interventions using quality-adjusted life-years. METHODS AND ANALYSIS: This is a 2×2 factorial, multicentre, phase III randomised controlled trial. The study population (with written informed consent) will consist of 432 women diagnosed with primary localised invasive breast carcinoma and eligible for adjuvant chemotherapy, hormonotherapy and/or radiotherapy. They will be randomly allocated between one of four arms: (1) web-based connected device (evolving target number of daily steps and an individualised, semisupervised, adaptive programme of two walking and one muscle strengthening sessions per week in autonomy), (2) therapeutic patient education (one educational diagnosis, two collective educational sessions, one evaluation), (3) combination of both interventions and (4) control. All participants will receive the international physical activity recommendations. Assessments (baseline, 6 and 12 months) will include physical fitness tests, anthropometrics measures, body composition (CT scan, bioelectrical impedance), self-administered questionnaires (physical activity profile (Recent Physical Activity Questionnaire), quality of life (European Organization for Research and Treatment of Cancer Quality-Of-Life Questionnaire-30, EQ-5D-5L), fatigue (Piper Fatigue Scale-12), social deprivation (Evaluation of Deprivation and Inequalities in Health Examination Centres), lifestyle, physical activity barriers, occupational status) and biological parameters (blood draw). ETHICS AND DISSEMINATION: This study was reviewed and approved by the French Ethics Committee. The findings will be disseminated to the scientific and medical community via publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT03529383; Pre-results.

Digital health interventions to help living with cancer: A systematic review of participants' engagement and psychosocial effects.

OBJECTIVE: Digital health interventions (DI) open the possibility for cancer patients and survivors to manage the disease and its side effects when they return home after treatment. This study aims to highlight the components of DI, investigate patient engagement with DI, and explore the effects of DI on psychosocial variables. METHODS: In September 2017, we performed a systematic review of studies focusing on DI which target cancer patients or survivors. RESULTS: A total of 29 articles (24 studies) were reviewed. There was considerable heterogeneity in study methods, in outcome definitions, in measures for engagement with DI and in psychosocial variables assessed. Results from the studies showed a high level of engagement. Self-efficacy, psychological symptoms, and quality of life were the most commonly assessed psychosocial variables. However, results for the effect of DI on psychosocial variables were inconsistent. Regarding pain management, results were in line with what one would expect. CONCLUSIONS: The present review showed that despite the heterogeneity in the studies assessed and inconsistent results, DI may constitute an excellent means to help cancer patients and survivors cope better with the disease and with treatment side effects, as they can improve self-management and wellbeing. In order to acquire a greater understanding of the mechanisms underlying cancer patients'/survivors' psychological and behavioral changes in terms of adopting DI, direct comparison between studies is needed. However, this can only come about if methodological and conceptual standardization of DI is implemented.

Dyadic effects of coping strategies, time perspectives, and personality on the quality of life of cancer patients and their caregivers.

OBJECTIVE: Researchers are interested in studying whether the quality of life (QoL) of cancer patients and caregivers is influenced by internal psychobehavioral processes (temporality and coping strategies) and the personality traits that they or their relatives experience. We examined these associations in a sample of patient-caregiver dyads by using the actor-partner interdependence model. METHODS: This cross-sectional study involved 156 cancer patient-caregiver dyads. The self-reported data included QoL (Short-Form 36), coping strategies (Brief Coping Orientation to Problems Experienced Scale), time perspectives (Zimbardo Time Perspective Inventory), and personality (Big Five Inventory). The actor-partner interdependence model was used to test the dyadic effect individualizing actor (degree to which the individual's characteristics were associated with their QoL) and partner (degree to which the individual's characteristics were associated with the QoL of the other dyad member) effects. RESULTS: Actor effects were found for patients and caregivers: The use of positive thinking and future/present-hedonistic perspectives were associated with higher QoL; the use of avoidance and past-negative perspective were associated with lower QoL. Partner effects were also found highlighting the specific mechanisms of the interconnections in the patient-caregiver dyad. The patient's QoL was higher when the caregiver used social support and experienced openness. The caregiver's QoL was lower when the patient used social support and avoidance strategies and experienced future perspective. CONCLUSIONS: The examination of the relationships between individuals' QoL and their internal psychobehavioral processes and personality traits will have several applications in the routine clinical management. Individual-level and dyad-level interventions should be proposed: cognitive-rehabilitation, emotional and cognitive self-regulation for time perspectives, and personality constructs.

[Determinants of the quality of life of the hearing-impaired elderly]. / Déterminants de la qualité de vie des sujets âgés présentant une déficience auditive.

AIM: The aim of this paper is to assess the relationships between psycho-behavioral determinants and quality of life in individuals with age-related hearing loss. METHODS: This is a cross-sectional study performed in a French preventive health center, Marseille, France (Institut Régional d'Information et de Prévention de la Sénescence). The patients had a bilateral (mild to moderately severe) age-related hearing loss. Data collected included : sociodemographics, general health information, quality of life (Hearing Handicap Inventory for the Elderly and World Health Organization Quality of Life questionnaire), emotional status (anxiety and mood disorders), emotional intelligence (Trait Emotional Intelligence Questionnaire Short Form), and coping strategies (Brief Coping Orientation to Problems Experienced Scale). RESULTS: Quality of life was linked to psycho-behavioral factors, such as emotional status, emotional intelligence, and coping strategies. CONCLUSIONS: These findings would assist health authorities and clinicians in choosing targeted appropriate interventions to improve quality of life of age related hearing loss individuals.

Domains of quality of life freely expressed by cancer patients and their caregivers: contribution of the SEIQoL.

BACKGROUND: The purposes of this study, performed on a large sample of cancer patient-caregiver dyads, were: i) to simultaneously investigate, using an individualized quality of life (QoL) measure (Schedule for the Evaluation of Individual QoL, SEIQoL), the QoL domains freely expressed by cancer patients and their caregivers, and ii) to explore overlapping between the SEIQoL assessment and QoL assessment using traditional instruments. METHODS: The study employed a cross-sectional design including cancer patients who were going to receive chemotherapy treatment and their caregivers. Quality of life was assessed using condition-specific questionnaires (EORTC QLQ-C30 and CarGOQoL), generic health-related questionnaire (SF-36), and open individualized measure (SEIQoL). RESULTS: The final sample included 205 patient-caregiver dyads. From the SEIQoL, Family, Health, and Leisures were the most freely expressed QoL domains by patients and caregivers, but reported with different weights. Love life and financial issues were less spontaneously mentioned. The SEIQoL index was moderately correlated to the condition-specific QoL questionnaires (R lower than |0.40|) and to SF-36 (correlation coefficients: R ranging from 0.17 to 0.31). CONCLUSION: Individualized QoL measures allow individuals to spontaneously express important, non-predefined domains. This study highlights the need to explore QoL using a combination of individualized questionnaires and standardized questionnaires, capturing complementary facets that patients consider important in their life.

Impact of caring for patients with severe and complex disabilities on health care workers' quality of life: determinants and specificities.

AIM: Individuals with severe and complex disabilities, defined by a combination of profound intellectual impairment and serious motor deficit resulting in extreme dependence, often remain in hospital or at residential facilities. The aim of this study was to identify the determinants of quality of life (QoL) of 238 health care workers (HCWs) caring for individuals with severe and complex disabilities. METHOD: We conducted a cross-sectional study. The recruitment of the HCWs was performed in five French centres specializing in patients with severe and complex disabilities. The selection criteria were age above 18 years, being an institutional referent HCW (a resource person coordinating various issues for or about the patient), and agreeing to participate. Sociodemographic, health, professional variables, and psycho-behavioural (QoL, burn-out, and coping strategies) data were collected. RESULTS: Of the 362 eligible HCWs, 65.7% returned the questionnaires. The scores of the physical and social dimensions of QoL were significantly lower, and the score of the psychological dimension significantly higher, than those of a comparison group. The main factors modulating QoL were age, financial difficulties, nature of coping strategy, and burn-out. INTERPRETATION: This research provides preliminary evidence that caring for patients with severe and complex disabilities affects the QoL of HCWs. These results support the need for optimization of the work environments for HCWs.

Assessment of coping: a new french four-factor structure of the brief COPE inventory.

BACKGROUND: The Brief Coping Orientation to Problems Experienced (Brief COPE) inventory is the most usual measure to identify the nature of coping strategies implemented by individuals and explore 14 coping strategies. The availability of a structure with fewer factors rather than the initial 14-factor structure may be of interest for both healthcare professionals and researchers. We report the validation process of a 4-factor structure of the French version of the Brief COPE in a French sample of individuals facing a singular life event, such as cancer, including patients and their caregivers. METHODS: The cross-sectional study included cancer patients and their caregivers. Self-administered data were collected including: socio-demographic (age, gender, marital status, employment status, and education level), coping strategies using the French version of the Brief COPE, quality of life (QoL) using the French version of the short form health survey questionnaire (SF36). Construct validity, internal consistency, reliability, and external validity were tested. RESULTS: The sample included 398 individuals. The principal component factor analysis identified a 4-factor structure. The dimensions were labeled according to their constitutive items: social support (8 items), problem solving (4), avoidance (10), and positive thinking (6). The 4-factor structure was supported by different theoretical models of coping and showed satisfactory psychometric properties. CONCLUSION: The 4-factor structure of the French version of the Brief COPE, validated in a sample of individuals facing a singular stressful event, including cancer patients and their caregivers, makes the instrument easier to use both in clinical practice and clinical research.

Age-related hearing loss in individuals and their caregivers: effects of coping on the quality of life among the dyads.

OBJECTIVES: Age-related hearing loss (ARHL) impacts the daily living and quality of life (QoL) of affected individuals and the functioning of family caregivers. In the specific context of voluntary medical checkups, we examined sample dyads (ARHL individual and the caregiver) to determine whether QoL of patients and caregivers is influenced by coping strategies implemented either by themselves or their relatives. METHODS: This was a cross-sectional study with a descriptive/correlative design performed in a French preventive health center (Regional Institute for Prevention of Aging, Marseille, France) for the beneficiaries of pension funds of private sector employees. The samples included beneficiary-caregiver dyads. The beneficiaries had bilateral (mild to moderately severe) ARHL. Self-reported data were collected as follows: QoL using the World Health Organization Quality of Life questionnaire, coping strategies using the Brief Coping Orientation to Problems Experienced Scale, and anxiety and mood using visual analog scales. RESULTS: The final sample comprised 44 beneficiaries and 44 caregivers. The caregiver was the partner of the beneficiary in 73% of cases. The QoL scores of the social dimension were significantly lower for beneficiaries and caregivers compared with French age- and sex-matched controls. Among beneficiaries and caregivers, coping strategies based on problem solving were the most commonly used strategies. The use of positive thinking strategies was associated with higher QoL scores. The more one member of the dyad used an avoidance coping strategy, the more the other member used a positive thinking strategy. CONCLUSION: This study emphasizes that QoL of individuals with age-related hearing impairment and their natural caregivers is related to the coping strategies that they use. This finding suggests that targeted interventions should be offered to help individuals who experience emotional difficulties to implement more efficient coping strategies.

Crossed views of burden and emotional distress of cancer patients and family caregivers during palliative care.

OBJECTIVE: Studies regarding natural caregivers' burden (CB) in palliative situations, as well as its determinants and consequences, have been numerous during the last 20 years. Yet, studies regarding how terminally ill cancer patients perceive their CB (self-perceived burden, SPB) are less common. This study aims to assess the links between CB and SPB evaluated by means of the very same items. It also aims at identifying the determinants of potential differences between CB and SPB and their consequences on emotional distress among both members of the dyad. METHODS: Sixty cancer patients from a palliative care unit and their principal natural caregiver completed questionnaires concerning the subjective burden of the caregiver, their own personal emotional distress and that of the other member of the dyad. RESULTS: Globally, patients had a good perception of their CB, although a little overestimated, except for their difficulties in managing their time. Caregivers overestimated patients' distress. The minimisation by patients of CB was a source of emotional distress for the latter, and the perception of being a burden to others was a source of depression for patients. These results did not depend on the nature of the relationship between patients and their caregivers. CONCLUSIONS: This data confirmed the need to study the experiences of the patient-caregiver dyad as well as their communication of their respective experiences, with a prospect to offer clinical interventions to optimise the quality of life and health of patients and their close relatives.Copyright © 2015 John Wiley & Sons, Ltd.

Determinants of patient delay in doctor consultation in head and neck cancers (Protocol DEREDIA).

INTRODUCTION: Reducing the time between the onset of the first symptoms of cancer and the first consultation with a doctor (patient delay) is essential to improve the vital prognosis and quality of life of patients. Longer patient delay is linked to the already known sociodemographic, socioeconomic, socioeducational, sociocultural and socioprofessional factors. However, recent data suggest that some sociocognitive and emotional determinants may explain patient delay from a complementary point of view. The main objective of this study is to assess whether, in head and neck cancer, patient delay is linked to these sociocognitive and emotional factors, in addition to previously known factors. METHODS AND ANALYSIS: We intend to include in this study 400 patients with a not yet treated head and neck cancer diagnosed in one of six health centres in the North of France region. The main evaluation criterion is 'patient delay'. Sociocognitive, emotional, medical, sociodemographic, socioeconomic, educational, professional and geographic factors will be assessed by means of (1) a case report form, (2) a questionnaire completed by the clinical research associate together with the patient, (3) a questionnaire completed by the patient and (4) a recorded semidirective interview of the patient by a psychologist (for 80 patients only). The collected data will be analysed to underline the differences between patients who consulted a doctor earlier versus those who consulted later. ETHICS: The study has obtained all the relevant authorisations for the protection of patients enrolled in clinical trials (CCTIRS, CCP, CNIL), does not involve products mentioned in article L.5311-1 of the French Code of Public Health, and does not imply any changes in the medical care received by the patients. The study began in October 2012 and will end in June 2015. TRIAL REGISTRATION: ID-RCB 2012-A00005-38.

Participation in randomised clinical trials is linked to emotion regulation strategies.

OBJECTIVES: Cancer patients' anxiety may curb their enrolment in clinical trials (CTs). Thus, the strategies they employ to reduce their anxiety may also determine their enrolment in CTs. The purposes of this study are (1) to compare the anxiety and emotion regulation strategies between patients who are enrolled in CTs (cases) and patients receiving standard cancer treatments who have never taken part in any CT (controls), and (2) to assess the links between these strategies and anxiety. METHODS: In total, 76 cases and 108 controls completed two validated questionnaires assessing their emotion regulation style (ERQ) and anxiety (STAI-Y). RESULTS: Overall, anxiety scores in cases and controls do not differ. The two groups do not differ in regards to their cognitive reappraisal of situations. However, cases inhibit their emotional expressions less than controls. Both cognitive reappraisal and emotional expressions are linked to lower scores of anxiety. CONCLUSIONS: Patients enrolled in CTs do not seem to be more anxious than those receiving a standard treatment. However, cancer patients' anxiety depends on the emotion regulation strategies they use. Emotion regulation during physician-patient interactions should be investigated further as a possible factor for CT enrolment determination.

Factual understanding of randomized clinical trials: a multicenter case-control study in cancer patients.

Objective Several reports have shown that despite the informed consent process, enrolled patients misunderstand the modalities and goals of randomized clinical trials (RCTs). We believe that this may be linked to a priori misconceptions in the main population. The purpose of this study is to compare the knowledge about cancer RCTs in enrolled participants (cases) versus patients treated under cancer standard care who have never taken part in RCTs (controls). Methods We submitted a validated questionnaire (ICEC-R) to both populations to explore their knowledge about RCTs. A total of 75 cases and 107 controls were included. Results Globally, the cases' knowledge was significantly better, especially about (i) the randomization process, (ii) the uncertain potential benefits, and (iii) the right to withdraw consent. Both populations presented the lowest scores for items exploring the randomization process and uncertain treatment benefits. Conclusion Enrolled patients' comprehension of the goals and means of RCTs is actually better than controls'. Nevertheless, additional efforts should be made to enhance information about clinical research to patients as well as to the main population. Practice Implications Having better knowledge about patients' difficulties in understanding RCTs would allow physicians to adjust the information they give and then to enhance patients' well-being.

[An index of understanding randomised clinical trials in oncology]. / Index de compréhension des essais cliniques randomisés en oncologie.

The first aim of this study was to build a French validated tool (ICEC-R) assessing the objective comprehension of the modalities and purposes of participating to a randomised clinical trial (phase II or III). The second goal of the study was to compare the scores different groups of participants got at the ICEC-R in accordance with their level of expertness in this domain (physicians vs patients included in a randomised CT vs patients with standard treatment vs uninformed) and to assess whether these scores of objective comprehension were, or not, impacted by the patients' anxiety state or their satisfaction about the care they receive. The sample was composed of 474 participants, namely 73 "target patients" suffering from cancer and participating to a randomised clinical trial, 97 "standard patients" suffering from cancer but who were not included in a clinical trial, 25 "physicians" who include patients in clinical trials, 18 "caregivers" who do not include patients in clinical trials, and 261 "uninformed" (psychology students). "Target" or "standard" patients received a questionnaire composed of the randomised clinical trials comprehension inventory (ICEC-R), a trait-state anxiety scale (STAI-Y), and a scale assessing their satisfaction about the care (SAT). In addition to general information, physicians, caregivers and uninformed only completed the ICEC-R. The analyzes led us to keep a one-dimensional comprehension inventory composed of ten items which are sufficiently discriminant among the patients and for which expert physicians gave consensual answers. Finally, the patients' answers to this questionnaire seem not to be influenced by either their anxiety or their satisfaction about the care. Better evaluations of the knowledge of the patients who participate to randomised clinical trials seem to be a distinct asset to improve these patients' global clinical care.

[Information spreading about hereditary carriage of a BRCA1/2 mutation and ovarian cancer and rate of consultation of the concerned relatives]. / Transmission de l'information dans les familles à risque héréditaire de cancer du sein et de l'ovaire mutées BRCA1/2 et taux de consultation des apparentés.

Five to 10% of breast and ovarian cancer are linked to a BRCA1 or BRCA2 mutation. In our country, the information given to the relatives is inevitably mediated by the persons who have consulted. The report of a gap between the number of presumed persons concerned by the genetic information according to our genealogies and the actual number of consultants brought us to question about the transmission of the information in the family, about the possible motives for the lack of transmission, about the rate of consultation of the concerned relatives and on the presumed motives of non-consultation. This sample includes 31 target consultants (index cases) of mutated families which received the result of the genetic test during the period from January, 2003 till June, 2005. According to the information gathered, most of the relatives (73.1%) are informed about the presence of a deleterious mutation in the family, especially women (80.7%). The motives for non-information are the social and emotional distance, as well as the stressful character of the information. Apparently the information is disclosed through the family by the women who are alive and carry the mutation. On the other hand, a minority of the women (39.7%) who are supposed to be informed and living in the region attended the oncogenetic consultation, which represents 32 % of all concerned women who come of age. The motives for short-term absence of consultation can just be presumed. The characteristics which we studied do not allow us to point out some particularities among women who consulted except the nearness with one mutated relative.