Evaluating the feasibility and acceptability of an adapted fencing intervention in breast cancer surgery post-operative care: the RIPOSTE pilot randomized trial.

Background: Adapted physical activity programs have shown promising results in reducing the physical, social and psychological side effects associated with breast cancer, but the extent to which they can be effectively adopted, implemented and maintained is unclear. The aim of this study is to use the framework to guide the planning and evaluation of programs according to the 5 following keys: Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to evaluate a fencing program under the French acronym RIPOSTE (Reconstruction, Image de soi, Posture, Oncologie, Santé, Thérapie, Escrime) literally in English (Reconstruction, Self-Image, Posture, Oncology, Health, Therapy, Fencing). This program is an innovative intervention focused on improving the quality of life (QoL) of breast cancer surgery patients through fencing. Methods: A convergent mixed methods pilot study was conducted to preliminary evaluate the different RE-AIM dimension of the pilot program. Twenty-four participants who have just undergone surgery for invasive breast cancer were randomly allocated in two groups: one group started immediately after their inclusion (Early RIPOSTE group) and the other started 3 months following their inclusion (Delayed RIPOSTE group). Participants answered a questionnaire at inclusion and at the end of the program on QoL, shoulder functional capacity, fatigue, anxiety-depression and physical activity. Results: RIPOSTE program was able to reach mainly young and dynamic participants, attracted by the originality of fencing and keen to improve their physical condition. Regarding effectiveness, our results suggest a trend to the improvement of QoL, shoulder functional capacity, fatigue and anxiety-depression state, even without any significant differences between the Early RIPOSTE group and the Delayed RIPOSTE group. Discussions: The cooperation, exchanges and cohesion within the group greatly facilitated the adoption of the program, whereas interruptions during school vacations were the main barriers. The intervention was moderately well implemented and adherence to the protocol was suitable. Conclusion: RIPOSTE is an acceptable and effective program for involving breast cancer survivors in physical activity, that needs to be tested at a larger scale to investigate its effectiveness, but has the potential to be transferred and scaled up worldwide.

Five-Year Symptom Trajectories in Nondialysis-Dependent CKD Patients.

BACKGROUND AND OBJECTIVES: Late stages of CKD are characterized by significant symptom burden. This study aimed to identify subgroups within the 5-year trajectories of symptom evolution in patients with CKD and to describe associated patient characteristics and outcomes. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Among 2787 participants (66% men) with eGFR <60 ml/min per 1.73 m2 enrolled in the CKD-Renal Epidemiology and Information Network (CKD-REIN) cohort study from July 2013 to May 2016, we assessed symptoms annually using the Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire until December 2020. A total of 9121 measures were reported over follow-up; all participants had symptoms scored for at least one time point. We used a joint latent class-mixed model to distinguish profiles of symptom trajectories. RESULTS: Patient mean age (±SD) at baseline was 67±13 years, and mean eGFR was 33±13 ml/min per 1.73 m2. The prevalence of each symptom ranged from 24% (chest pain) to 83% (fatigue), and 98% of participants reported at least one symptom. After a median (interquartile range) follow-up of 5.3 (3.4-6.0) years, 690 participants initiated KRT, and 490 died before KRT. We identified two profiles of symptom trajectories: a "worse symptom score and worsening trajectory" in 31% of participants, characterized by a low initial symptom score that worsened more than ten points over time, and a "better symptom score and stable trajectory" in 69% of participants, characterized by a high initial score that remained stable. Participants in the worse symptom score and worsening trajectory group had more risk factors for CKD progression at baseline, worse quality of life, and a higher risk of KRT and death before KRT than other participants. CONCLUSIONS: This study highlights a significant worsening of symptoms in about one third of the participants, whereas the majority reported low symptom severity throughout the study.

Physical Activity and Eating Behavior Inequalities Mediating the Effects of Socioeconomic Status and Sex on Adolescent Quality of Life: Insights of the PRALIMAP Trial.

BACKGROUND: This study aimed to quantify the 2-year mediating effects of physical activity (PA) and eating behavior (EB) on socioeconomic and sex inequalities in quality of life (QoL) among French adolescents. METHODS: Adolescents from a 2-year school-based trial were included. PA and EB were assessed at baseline, 1 year, and 2 years using the International Physical Activity Questionnaire and an eating habits questionnaire, respectively. QoL was measured at 2 years using the Duke Health Profile questionnaire. The mediating effect of adherence to PA and EB guidelines in the associations between socioeconomic status or sex and QoL was analyzed with a counterfactual method. RESULTS: Among the 3562 included adolescents (mean age, 15.2 [0.6] y), being a boy and having a high socioeconomic status was associated with high QoL. Differences in QoL by socioeconomic status were mediated by adherence to guidelines for PA (up to 10.2%) and EB (up to 8.8%), and differences in QoL by sex were predominantly mediated by adherence to guidelines for PA (up to 163.8%). CONCLUSIONS: Policies, programs, and interventions designed to reduce socioeconomic and sex inequalities in QoL among adolescents could use PA and EB as leverage.

Adapted Fencing for Patients With Invasive Breast Cancer: The RIPOSTE Pilot Randomized Controlled Trial.

Introduction: Even if indications for mastectomy have been progressively reduced in loco-regional breast cancer (BC) treatment, the harmful effects of surgery are still numerous and can impact physical and psychological wellbeing of women. The RIPOSTE (Reconstruction, self-Image, Posture, Oncology, "Santé"-Health, Therapy, "Escrime"-Fencing) program aimed to propose adapted fencing to patients with BC. This study aims to investigate the effect and conditions of effectiveness of the RIPOSTE program. Methods and analysis: This is a prospective randomized controlled trial including 24 patients with invasive BC who have just undergone surgery. The study will be proposed to the patient and if interested, the patient will be referred to a sports physician for a medico-sportive evaluation. At the end the evaluation, if the patient meets the inclusion criteria, she will be randomly assigned to one of the 2 groups based on a 1:1 principle: Early RIPOSTE group (receive one fencing session per week for 3 months immediately after their inclusion), Delayed RIPOSTE group (receive one fencing session per week for 3 months but within the 3 months following their inclusion). Patients will be included for 6 months with 3 follow-up times (0, 3, and 6 months) by a sport physician. The primary outcome is the evolution of quality of life score. Secondary outcomes are disability score, fatigue, anxiety-depression, cost-effectiveness and process evaluation. Ethics and dissemination: The study protocol has been approved by a French ethics committee (CPP Sud Méditerranée IV, N°ID-RCB: 2020-A01916-33). Results will be submitted for publication, at scientific conferences and through press releases. Trial Registration: NCT04627714.

Sociodemographic and psychological characteristics associated with discrepancy between body satisfaction and weight change among adolescents.

This study aimed to describe the discrepancy between body satisfaction change and weight change among adolescents following a 2-year school-based intervention, to identify associated sociodemographic factors, and to explore possible associations with perceived health indicators. We used data from a northeastern France representative adolescents sample (14-18 years old) who participated in the PRALIMAP (PRomotion de l'ALIMentation et de l'Activité Physique) study (2006-2009). Weight change was measured by the change in body mass index z-score from the start to the end of the study. Body satisfaction and self-perceived health (anxiety, depression, eating disorder and quality of life) changes were assessed using self-administered questionnaires. Discrepancy between body satisfaction change and weight change was described with cross-tabulations, and subdivided into optimism/pessimism (i.e. positive/negative body satisfaction change compared to weight change). Sociodemographic factors associated with discrepancy were determined by multivariate logistic regression models. Adjusted linear regression models described 2-year change in weight and self-perceived health according to discrepancy. Among the 3279 adolescents included (aged 15.1 ± 0.6 years), the proportion of discrepancy was 74.8% (pessimism = 41.6%; optimism = 33.2%). Discrepancy, especially pessimism, was higher in boys than in girls (OR = 1.44 [1.19; 1.74], p = .0002), and in socially advantaged adolescents (OR = 1.82 [1.20; 2.74], p = .004) than in disadvantage ones. Body satisfaction change was rather in line with anxiety, depression and quality of life changes than weight change. Body satisfaction change should be considered in overweight and obesity prevention interventions alongside body weight change, and could be used as indicator of long-term behavior maintenance. Clinical trials registry and number:ClinicalTrials.gov (NCT01688453).

Longitudinal patterns of lifestyle behaviours in adolescence: a latent transition analysis.

The interdependence among eating behaviour (EB), physical activity (PA) and sedentary time (ST) suggests simultaneously identifying homogeneous profiles and describing their changes. This study aimed to (1) identify cross-sectional lifestyle behaviour profiles and their 2-year changes among French school-age adolescents and (2) identify factors associated with these profiles and changes. Longitudinal data from adolescents who participated in the PRomotion de l'ALIMentation et de l'Activité Physique trial were used. PA and ST were assessed with the International Physical Activity Questionnaire and EB with a FFQ. Profiles at baseline and their changes were identified by latent transition analysis. Multinomial logistic regression models were used to identify factors associated with profiles and their changes. Among 2390 adolescents included (14-18 years), five baseline profiles that differed mainly in EB were identified: 'healthy diet and high PA (7·9 %)', 'big eater and moderate to high PA (23·8 %)', 'healthy diet and low PA (31·2 %)', 'restrictive diet and moderate PA (20·6 %)' and 'sugar products, nibbling and moderate PA (16·5 %)'. Young adolescents, those who were overweight or obese and socially advantaged, were more in the 'healthy diet and low PA' than others. Boys, older and socially less advantaged adolescents exhibited more 'unfavourable' than 'mixed' changes, while adolescents with overweight or obesity had less 'unfavourable' than 'mixed' changes. In conclusion, adolescents were twice the number in the least than the most favourable profile. Findings highlighted the importance of EB among adolescents and suggest taking adolescents' sociodemographic and weight characteristics into account in interventions aimed at acting on adolescents' behaviours.

Memory improvement in multiple sclerosis after an extensive cognitive rehabilitation program in groups with a multicenter double-blind randomized trial.

OBJECTIVE: The aim of this study is to determine the effectiveness of an extended cognitive rehabilitation program in group's sessions in multiple sclerosis. DESIGN: Double-blind multicenter randomized trial. PARTICIPANTS: People with multiple sclerosis of 18 to 60 years, Expanded Disability Status Scale ⩽6.0, mild to moderate cognitive impairment. INTERVENTIONS: They were randomized into cognitive rehabilitation program (ProCog-SEP) or in a placebo program. ProCog-SEP comprises 13 group's sessions over 6 months and includes psychoeducational advices and cognitive exercises. Placebo program included non-cognitive exercises. No strategy and no cognitive advice were provided. MAIN MEASURES: The primary endpoint was the percentage of verbal memory learning measured by the Selective Reminding Test. A comprehensive neuropsychological assessment is carried out before and after interventions by a neuropsychologist blinded to intervention. Effectiveness of the ProCog-SEP versus Placebo has been verified using linear regression models. RESULTS: In total, 128 participants were randomized and 110 were included in the study after planning session in groups; 101 completed this trial (77.2% females); mean age: 46.1 years (±9.6); disease duration: 11.8 years (±7.5). ProCog-SEP was more effective in increasing in learning index (9.21 (95% confidence interval (CI): 1.43, 16.99); p = 0.02) and in working memory on manipulation (0.63 (95% CI: 0.17, 1.09); p = 0.01), and updating capacities (-1.1 (95% CI: -2.13, -0.06); p = 0.04). No difference was observed for other neuropsychological outcomes. Regarding quality of life outcomes, no change was observed between the two groups. CONCLUSION: These findings suggest that ProCog-SEP could improve verbal learning abilities and working memory in people with multiple sclerosis. These improvements were observed with 13 group sessions over 6 months.

Five-year Evolution Patterns of Physical Activity and Sedentary Behavior in Patients with Lower-limb Osteoarthritis and Their Sociodemographic and Clinical Correlates.

OBJECTIVE: The present study aimed to identify trajectories of physical activity (PA) components (frequency, duration, intensity, and type) and screen-based sedentary behavior (SB) as well as baseline predictors of each trajectory in patients with hip and/or knee osteoarthritis (OA). METHODS: We included 878 patients with a 5-year follow-up from the KHOALA cohort. PA and SB were measured by the Modifiable Activity Questionnaire. We used group-based trajectory analysis to identify the trajectories of PA components and screen-based SB, and multivariable logistic regression to determine predictors of the identified trajectories. RESULTS: Two groups of trajectories were identified for each PA component and 3 for SB. High and decreasing PA duration was associated with female sex (OR 0.3, 95% CI 0.1-0.5) as was low and stable, more so than high and decreasing prevalence of weight-bearing activities (OR 0.6, 95% CI 0.4-0.9). Patients with impaired patient-reported outcome measures and obese patients often featured low versus high and decreasing prevalence of weight-bearing activities. Predictors of moderate and high versus low and slightly increasing screen-based SB trajectories were male sex, age < 60 years, single status (OR 1.5, 95% CI 1.1-2.1), obesity (OR 2.1, 95% CI 1.4-3.1), smoking (OR 2.0, 95% CI 1.1-3.7), and less physical jobs. Predictors of moderate and high versus low screen-based SB trajectories were all sociodemographic: male sex, age < 60 years, single status, obesity, smoking, and less physical jobs. CONCLUSION: Sociodemographic and clinical predictors of trajectories vary between PA components; they are associated mainly with PA frequency and type. No clinical characteristics were associated with screen-based SB.

Physical activity rather than sedentary behaviour is socially determined in French adolescents with overweight and obesity.

Social differences in prevalence of overweight and obesity among adolescents, known as the weight social gradient, could be explained by differences in behaviours between social classes. This study examined the respective association of physical activity (PA), sedentary behaviour (SB) and weight status with adolescents' socioeconomic status. We used cross-sectional data for 1935 adolescents (13-18 years old) with overweight or obesity who participated in the PRALIMAP-INÉS (PRomotion de l'ALImentation et de l'Activité Physique - INÉgalités de Santé) trial conducted in northeastern France between 2012 and 2015. Adolescents completed the International Physical Activity Questionnaire for PA and SB and the Family Affluence Scale for socioeconomic status. Weight status was assessed by the body mass index (BMI) and BMI z-score. Social gradient of weight status, PA and SB were described according to the Family Affluence Scale (slopes) and evidenced by the linear trend test (p). Adolescents' socioeconomic status was positively associated with PA practice (frequency, vigorous PA and leisure-time PA), but there was no association with their SB. The results confirmed a significant weight social gradient: BMI (ß = 0.37, p < .0001) and BMI z-score (ß = 0.07, p = .0001). The weight social gradient in adolescents was mostly associated with PA (5.7% to 8.1%) rather than SB (2.7% to 5.7%). Nearly 14% of BMI z-scores could be related to a combined PA and SB effect. PA was found an important factor of weight social gradient in adolescence. Actions aimed at preventing weight social inequalities among adolescents could include PA promotion as lever. CLINICAL TRIALS REGISTRY AND NUMBER: ClinicalTrials.gov (NCT01688453).

Effectiveness of a socially adapted intervention in reducing social inequalities in adolescence weight. The PRALIMAP-INÈS school-based mixed trial.

BACKGROUND: A high prevalence of overweight/obesity among low socioeconomic status adolescents contributes to health inequalities. However, evidence-based interventions for reducing social inequalities in adolescent weight are lacking. We aimed to investigate whether strengthened care management for adolescents with low socioeconomic status has an equivalent effect in reducing overweight as standard care management in adolescents with high status. METHODS: PRALIMAP-INÈS was a multicentre trial including 35 state-run high and middle schools in the north-eastern France. A population-based sample of 1639 adolescents aged 13-18 years with screened and clinically confirmed overweight/obesity were proposed for inclusion and divided into two groups by the Family Affluence Scale score: advantaged (score > 5), receiving standard care management (A.S) and less-advantaged randomly assigned to two groups (1:2 ratio): standard care management (LA.S) and standard and strengthened care management (LA.S.S). Interventions were based on the proportionate universalism principle: universal standard care for all groups and proportionate care for the LA.S.S group. Main outcome was body mass index z-score (BMIz) assessed before and 1 year after inclusion. RESULTS: A total of 1419 adolescents were included and 1143 followed up at 1 year: 649 in A.S, 158 in LA.S and 336 in LA.S.S groups. BMIz decreased significantly for boys (-0.11 [95% CI, -0.13 to -0.08]; p < 0.0001) and girls (-0.05 [-0.08 to -0.03]; p < 0.0001). No equivalence between LA.S.S and A.S groups was evidenced. For girls, the trend to superiority for LA.S.S was confirmed by the more favourable change (-0.06 [-0.11 to -0.01]; p = 0.01) observed on superiority analysis, with no differential change for boys (0.02 [-0.03 to 0.08]; p = 0.41). CONCLUSIONS: A public health school-based intervention using the proportionate universalism principle may be effective in not worsening or even reducing overweight social inequalities in adolescents, especially for girls. Overcoming social barriers may help health professionals dealing with the burden and inequalities of overweight in adolescents.

Universal School-Based Intervention Does Not Reduce Socioeconomic Inequalities in Weight Status among Adolescents.

Background: Differences in weight status by socioeconomic position occur during adolescence and is known as weight social gradient (WSG). The PRALIMAP (Promotion de l'ALIMentation et de l'Activité Physique) trial highlighted that a universal intervention was effective in reducing overweight and obesity prevalence among adolescents. However, its ability to reduce the WSG is unclear. This study aimed to evaluate the impact of the PRALIMAP intervention on the WSG among adolescents. Methods: Data were obtained from 3504 adolescents who participated in the school-based PRALIMAP trial between 2006 and 2009. The PRALIMAP study consisted of three interventional strategies: educational, environmental, screening and care. Weight status was assessed by body mass index (BMI) z-score and overweight and obesity prevalence. The "indice de position sociale des élèves" was used to measure adolescents' socioeconomic status. Linear regression and hierarchical models were used to assess the WSG and its evolution, respectively. Results: Among all adolescents (14-18 years old), significant WSG was identified at baseline: BMI z-score (ß = -0.06; p < 0.0001), overweight and obesity prevalence (ß = -2.86; p < 0.0001). Overall, the intervention conferred no significant reduction in the WSG: BMI z-score (ß = -0.01 [-0.02 to 0.01], p = 0.48), overweight and obesity prevalence (ß = -0.01 [-0.07 to 0.05], p = 0.73). Similar results were observed for adolescents whatever the interventional strategy they benefited from in the PRALIMAP trial. Conclusions: This study provided no evidence that the PRALIMAP universal intervention was effective in reducing the socioeconomic inequalities in weight status among adolescents. Different interventions that account for social differences should be considered to tackle these inequalities.

Impact of comorbidities and functional impairment on 5-year loss of health utility in patients with lower-limb osteoarthritis in the KHOALA cohort.

PURPOSE: To examine the respective and combined impact of "hypothetical" functional impairment (FI) and burden of comorbidities accrual on a 5-year risk of health utility (HU) loss in osteoarthritis (OA). METHODS: Participants of the Knee and Hip Osteoarthritis Long-term Assessment (KHOALA) study with a 5-year follow-up were included. FI, number of comorbidities and HU were measured annually by the WOMAC, Functional Comorbidity Index and Short-Form 6D, respectively. We estimated the population risk of HU loss (PRD: population risk difference, PRR: population risk ratio) under hypothetical FI and comorbidities using the parametric G-formula. Then, mediation analysis investigated the causal mechanism of comorbidities on HU through FI by estimating total, direct and indirect effects. RESULTS: We examined data from 767 patients (68.8% women; 61.6 years). The estimated 5-year risk of HU loss was 47.5% [41.9; 52.2] under natural course and 24.9% [15.5; 34.2] when imposing "Patient acceptable function and No comorbidity" corresponding to a PRD = - 22.6 [- 26.5; - 21.2] and a PRR = 0.5 [0.4; 0.6]. The estimated total risk of HU loss comparing "Two comorbidities" versus "No comorbidity" was significant without mediation effect of FI: Total = 10.1% [6.8; 12.9]; direct = 8.0% [2.7; 13.1]; indirect = 2.1% [- 2.0; 5.2]. CONCLUSIONS: FI and comorbidities are important and independent determinants of HU loss in patient with OA. Half of cases (50%) of HU loss during 5 years could be avoided by preventing comorbidities (30%) and limiting FI under patient acceptable function (20%). Caregivers should additionally pay close attention to the prevention and the treatment of comorbidities in routine management of OA.

Reach and Acceptability of a Mobile Reminder Strategy and Facebook Group Intervention for Weight Management in Less Advantaged Adolescents: Insights From the PRALIMAP-INÈS Trial.

BACKGROUND: Although information and communication technology interventions appear to be a promising means of reducing the health inequality gap in overweight and obesity prevention, research on information and communication technology interventions is lacking outside the Anglo-Saxon world. OBJECTIVE: The aim of this study was to assess the reach and acceptability of 2 information and communication technology interventions delivered as part of a French nutritional program: an SMS text messaging (short message service, SMS) attendance-reminder for collective sessions strategy and a Facebook challenge group. METHODS: This study sample comprised 262 socially less advantaged overweight adolescents aged between 13 and 18 years. The information and communication technology interventions were carried out during the 2013-2014 academic year in 33 French state-run schools. For the SMS attendance-reminder for collective sessions strategy, at the start of the academic year, adolescents were asked to give their mobile number. SMS attendance-reminders were sent shortly before each of the 5 collective sessions. For the Facebook challenge group, adolescents were invited to join a closed Facebook group in which challenges on physical activity and on diet were posted weekly. Process data and 2 sets of face-to-face interviews were also used to interpret participation rates and access to Facebook. Appreciation for both interventions was evaluated by a questionnaire at the end of the academic year. RESULTS: Of the recruited adolescents, 79.0% (207/262) gave their mobile number, reflecting high access to a mobile phone. Giving a number was significantly more likely for girls (odds ratio [OR] 2.1, 95% CI 1.1-3.9; P=.02) and adolescents in a vocational or general high school as opposed to middle school (OR 1.0, 95% CI 0.4-2.7; OR 0.2, 95% CI 0.1-0.5; P<.001). Indicating a mobile number at the start of the year was not significantly associated with participation in collective sessions. Of the adolescents seen at the start-of-year face-to-face interviews, 78.1% (153/196) declared an interest in the Facebook challenge group, which implies having a Facebook account or being able to have access to one. However, only 21 adolescents went through the process of joining the group. Although there was satisfaction with the Facebook group among the participants, the low participation rate in the Facebook group does not allow conclusions to be drawn with confidence. CONCLUSIONS: The results are in line with the claim that using information and communication technologies in health programs is unlikely to widen health inequalities. However, in this population of French adolescents, mobile phone strategies seem more adapted to a high school context, and caution should be exercised with a younger audience. Although there is positive appreciation of the SMS attendance-reminders and a Facebook intervention is initially highly appealing to less advantaged adolescents, no evidence of impact could be demonstrated. These results highlight the difficulty in assessing the impact of specific interventions in complex health programs. TRIAL REGISTRATION: Clinicaltrials.gov NCT01688453; https://clinicaltrials.gov/ct2/show/NCT01688453 (Archived by WebCite at http://www.webcitation.org/6yy6EQ0SM).

Measuring adolescents' weight socioeconomic gradient using parental socioeconomic position.

Background: There is an evidence of social inequalities in weight status in adolescence but the diversity of family socioeconomic status (SES) indicators can lead to discrepant findings. We aimed to identify how combination of family SES indicators can help measuring weight socioeconomic gradient (WSG) among adolescents. Methods: Cross-sectional data from 2113 adolescents (13-18 years old) of the PRALIMAP-INÈS trial were used. Multiple SES indicators and assessment of weight status including body mass index (BMI), waist circumference (WC), waist-to-height ratio (WHtR) and self-perception of overweight were used. We used principal component analysis (PCA) followed by structural equation models to identify SES dimensions. A dimension normalized score was calculated ranging from 1 to 10 (a high score corresponding to high SES). Linear regression models (linear trend test) were used to assess the WSG. Results: Three SES dimensions were identified: (i) 'Family social status', (ii) 'Family education level' and (iii) 'Family income level'. BMI was significantly lower in highly advantaged compared with highly less advantaged [-1.64 (-2.39; -0.89) for family social dimension, -0.86 (-1.37; -0.36) for family education level and -2.35 (-3.65; -1.05) for family income level]. Similar results were observed for all weight indicators excepted for self-perception of overweight status. Socially less advantaged adolescents perceived themselves less fat than they were. Conclusion: Although WSG was evident in adolescence, association between SES and weight status differed according to objective or perceived weight indicators. The proposed SES dimension can be applied in other field and future studies are needed to confirm our findings.

The impact of physical activity on fatigue and quality of life during and after adjuvant treatment for breast cancer.

BACKGROUND: Although physical activity (PA) can alleviate fatigue and improve quality of life (QoL) in patients with breast cancer (BC), not all domains of PA may have equal impact. The objective of the current study was to examine the longitudinal impact of PA components on the evolution of fatigue and QoL during and after adjuvant treatment for BC. METHODS: The women included in the study were participants in the 2-year longitudinal FATSEIN ("Fatigue dans le cancer du Sein") study. Fatigue and QoL were measured using the Multidimensional Fatigue Inventory and the European Organization for Research and Treatment of Cancer 30-item QoL questionnaire, respectively. Group-based trajectory analysis was used to determine patterns of PA evolution (frequency, duration, and intensity). Cross-sectional and longitudinal associations between PA patterns and fatigue and QoL were analyzed by using multivariable linear regression and a mixed model. RESULTS: Among the 424 women who were included (mean ± standard deviation age, 57.1 ± 10.4 years), 2 trajectories were identified for each of the 3 PA components: low and insufficient frequency (51.2%) or regular and moderate frequency (48.8%), low and insufficient duration (47.6%) or regular and moderate duration (52.4%), and low intensity (47.2%) or low to moderate intensity (52.8%). Overall, during treatment, fatigue was increased and QoL was decreased, and the reverse was observed after treatment. During treatment, increased fatigue and decreased QoL were limited by regular PA frequency (ß = -8.71 for total fatigue; ß = 14.59 for emotional function), but the results were less significant after treatment. CONCLUSIONS: PA, especially its frequency, is an important determinant of fatigue and QoL during adjuvant treatment for BC. The promotion of regular PA among women who are receiving treatment for BC may be an effective way to reduce fatigue and improve QoL. Cancer 2018;124:797-806. © 2017 American Cancer Society.

Nephrectomy Complication Is a Risk Factor of Clinically Meaningful Decrease in Health Utility among Living Kidney Donors.

OBJECTIVES: To assess the clinically relevant change in health state utility (HSU) in living kidney donors and whether this change value is constant across measures and clinical conditions and is useful for health economics studies. We aimed to 1) measure the change in the HSU score for living kidney donors from before donation to 3 months after donation and 2) estimate the minimal important decrease (MIDe) in the HSU score for living kidney donors and its associated clinical factors. METHODS: Data from a prospective multicenter observational study measuring quality of life of kidney donors by the three-level EuroQol five-dimensional questionnaire (EQ-5D-3L) and the six-dimensional health state short form (SF-6D) before donation and at 3 months after donation provided HSU scores. Two methods were used to derive the MIDe: the anchor-based method and the distribution-based (standard error of measurement) method. Logistic regression was used to identify clinical factors associated with the MIDe after donation. RESULTS: In total, 228 and 216 donors completed the EQ-5D-3L and the SF-6D, respectively. Mean HSU scores were 0.932 and 0.823 before donation and 0.895 and 0.764 at 3 months after donation. HSU scores were significantly decreased at 3 months, and 18.5% of donors rated their global health as "somewhat worse." By the EQ-5D-3L and the SF-6D, the MIDe was estimated at -0.113 and -0.116 with the anchor-based method and -0.075 and -0.077 with the distribution-based method. Risk of decreased HSU score was significantly associated with clinical complications but only marginally with surgical technique. CONCLUSIONS: A short-term clinically relevant decrease in HSU was significantly associated with clinical complications in kidney donors. Preventing perioperative complications is of prime importance in kidney donation.

Association of socioeconomic, school-related and family factors and physical activity and sedentary behaviour among adolescents: multilevel analysis of the PRALIMAP trial inclusion data.

BACKGROUND: Social differences among adolescents in physical activity and sedentary behaviour have been identified but are not well explained. The current study aimed to identify socioeconomic, family and school-related associated factors with physical activity and sedentary behaviour among high-school adolescents. METHODS: This was a cross-sectional analysis of T0 physical activity and sedentary behaviour of 2523 students 14 - 18 years old recruited for the PRALIMAP trial from 24 French state-run high schools. Data were collected by self-administered questionnaire at the start of grade 10. Adolescents completed the International Physical Activity Questionnaire for physical activity and sedentary behaviour and an ad hoc questionnaire for active commuting and sport participation. Statistical analyses involved linear and logistic regressions. RESULTS: Socioeconomic, family or school variables were associated with levels of physical activity and sedentary behaviour for both boys and girls, but no factor, except perceived parental physical activity level, was associated with total energy expenditure (total physical activity) for either gender. Adolescents with privileged and less privileged socioeconomic status reported the same total amount of energy expenditure. CONCLUSIONS: Total physical activity score alone is not sufficient to assess the physical activity of adolescents. These findings may have implications for better understanding of social inequalities in this context and recommendations to prevent overweight. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov ( NCT00814554 ). The date of registration: 23 December 2008. Registration was not required at the time of the start of PRALIMAP for public health and prevention programmes and trials.

Reducing social inequalities in access to overweight and obesity care management for adolescents: The PRALIMAP-INÈS trial protocol and inclusion data analysis.

BACKGROUND: Despite social inequalities in overweight/obesity prevalence, evidence-based public health interventions to reduce them are scarce. The PRALIMAP-INÈS trial aimed to investigate whether a strengthened-care management for adolescents with low socioeconomic status has an equivalent effect in preventing and reducing overweight as a standard-care management for high socioeconomic status adolescents. METHODS: PRALIMAP-INÈS was a mixed, prospective and multicenter trial including 35 state-run schools. It admitted overweight or obese adolescents, age 13-18 years old, for 3 consecutive academic years. One-year interventions were implemented. Data were collected before (T0), after (T1) and post (T2) intervention. Among 2113 eligible adolescents who completed questionnaires, 1639 were proposed for inclusion and 1419 were included (220 parental refusals). Two groups were constituted according to the Family Affluence Scale (FAS) score: the less advantaged (FAS≤5) were randomly assigned to 2 groups in a 2/1 ratio. The 3 intervention groups were: advantaged with standard-care management (A.S, n = 808), less advantaged with standard-care management (LA.S, n = 196), and less advantaged with standard and strengthened-care management (LA.S.S, n = 415). The standard-care management was based on the patient education principle and consisted of 5 collective sessions. The strengthened-care management was based on the proportionate universalism principle and consisted of activities adapted to needs. INCLUSION RESULTS: The written parental refusal was less frequent among less advantaged and more overweight adolescents. A dramatic linear social gradient in overweight was evidenced. DISCUSSION: The PRALIMAP-INÈS outcomes should inform how effectively a socially adapted public health program can avoid worsening social inequalities in overweight adolescents attending school. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01688453).

10-year cumulative and bidirectional associations of domain-specific physical activity and sedentary behaviour with health-related quality of life in French adults: Results from the SU.VI.MAX studies.

BACKGROUND: The directionality of the associations of domain-specific physical activity (PA) and sedentary behaviour (SB) with health-related quality of life (HRQoL) in adults remain insufficiently known. This study investigated the longitudinal associations of 10-year cumulative levels of PA and SB with HRQoL and the reverse associations. METHODS: A sample of 2093 (47.8% men) participants from a cohort of French adult (SU.VI.MAX) was included. Data were collected at 3 time points (1998, 2001 and 2007) using the Modifiable Activity Questionnaire (MAQ) for PA (leisure-time and occupational) and SB (screen-viewing, reading and total sitting time) and the DUKE Health Profile for HRQoL. The cumulative level (from 0 to 3) referred to the number of time points where a high PA level, high SB or good HRQoL was reported. Regression models examined the 10-year cumulative level of PA, SB as predictors of HRQoL and reverse associations. RESULTS: The 10-year cumulative level of high PA, both leisure-time and occupational, predicted a higher HRQoL while the 10-year cumulative level of high screen-viewing time and high total sitting time was associated with lower HRQoL. For the reverse association, cumulative level of good HRQoL predicted more leisure-time PA, less screen-viewing time and less total sitting time but was not related to occupational PA. CONCLUSION: Relationships between PA, SB and HRQoL are complex and should not be oversimplified in one or the other direction. Taking into account domain-specific PA and SB in health promotion programs appears of prime importance to design interventions aiming at improving HRQoL.

Cumulative and bidirectional association of physical activity and sedentary behaviour with health-related quality of life in adolescents.

BACKGROUND: The directionality of the association of physical activity (PA) and sedentary behaviour (SB) with health-related quality of life (HRQoL) remains unknown in adolescents. This study aimed to investigate the association of 2-year cumulative level of PA and SB with HRQoL and the reverse association. METHODS: We included 1445 adolescents in France from a 2-year longitudinal study with three follow-up times (PRALIMAP trial). At each follow-up, adolescents completed the International Physical Activity Questionnaire for PA and SB and the Duke Health Profile for HRQoL. Statistical analyses involved linear and logistic regressions adjusted for socio-demographic characteristics. RESULTS: The cumulative number of times an adolescent achieved the PA recommendations during the 2 years was associated with better physical, mental, social and general HRQoL (p for trend < 0.0001). In contrast, high SB predicted low HRQoL for most dimensions except social HRQoL (p = 0.12). Combining PA and SB, the effect of recommended PA on HRQoL was offset in part by high SB. In the reverse association, high HRQoL predicted high PA (overall, vigorous, moderate and recommended PA), but was not associated with SB. CONCLUSIONS: The association between PA and HRQoL was cumulative and bidirectional among adolescents, whereas low HRQoL seemed to be a consequence of high SB rather than a cause (cumulative but not bidirectional). Promoting recommended PA and low SB may help improve HRQoL among adolescents, with a possible virtuous cycle with regard to PA.