Breast cancer survivors' opinion on personalizing endocrine therapy and developing informative tools.

Understanding breast cancer survivors' perspectives is critical to personalizing endocrine therapy (ET) in the adjuvant setting. A nationwide survey among breast cancer survivors was proposed in France, in collaboration with patient advocacy organizations, to assess their perspectives on personalizing ET and developing dedicated informative tools. This survey explored patients' preferences regarding ET intake schedule, formulation, presentation (color, taste, shape, size, design, and packaging), combination with agents targeting ET-related adverse events, and a mobile application to support them during ET. Of the 1103 individuals who started the survey, 939 (85.1%) were eligible for enrollment and completed the survey. The majority of the participants considered that a personalized ET should take into consideration the intake schedule (n = 974, 90.7%) and swallowable tablet formulation (n = 606, 64.5%), without a preference for ET presentation (n = 619; 65.9%). The majority of the participants expressed a willingness to participate in a potential clinical trial evaluating the combination of ET with agents targeting ET-related adverse events at the start of ET (n = 752, 80.1%) or in the case of major ET-related adverse events (n = 778, 82.8%). The primary considerations were to have an uncompromised ET efficacy and a guaranteed reduction of adverse events. Last, a dedicated mobile application was considered helpful by 665 participants (70.8%). Informative tools should focus on the recommendations for dealing with adverse events (n = 593, 63.2%), the impact on the patient's daily life (n = 515, 54.9%), benefits (n = 504, 53.7%), and adverse events (n = 494, 52.6%) of ET. This survey paves the way for multimodal strategies that can include a personalized ET (e.g., ET in combination with agents targeting ET-related adverse events) and dedicated mobile applications to ultimately improve adherence.

An effort to improve the collection of patient-generated data: readability and understandability of patient-reported outcomes measures in a survivorship cohort.

PURPOSE: In this study, we evaluated readability and understandability of nine French-language Patient-Reported Outcome Measures (PROMs) that are currently used in a contemporary longitudinal cohort of breast cancer survivors as part of an effort to improve equity in cancer care and research. METHODS: Readability of PROMs was assessed using the Flesh Reading Ease Score (FRES), the Gunning's Fog Index (FOG), and the FRY graphics. Readability was considered ideal if mean score ≤ 6th-grade level and acceptable if between 6th and 8th grade. Understandability was evaluated using the Patient Education Materials Assessment Tool and defined as ideal if PEMAT ≥ 80%. The Evaluative Linguistic Framework for Questionnaires (ELF-Q) provided additional qualitative elements to assess understandability. Plain-language best practice was met if both readability and understandability were ideal. RESULTS: None of the 9 PROMs evaluated had ideal readability scores and only 1 had an acceptable score. Understandability ranged from 55% to 91%, and only 3 PROMs had ideal scores. ELF-Q identified points for improvement in several understandability dimensions of the PROMs. None of the instruments met the definition of plain-language best practice. CONCLUSION: None of the studied PROMs met the standards of readability and understandability. Future development and translation of PROMs should follow comprehensive linguistic and cultural frameworks to ensure plain-language standards and enhance equitable patient-centered care and research.

Co-construire un projet de recherche en oncologie avec les personnes concernées : retour d'expérience et leçons apprises.

Citizen participation in cancer research is growing intensively. In this context, the IMPAQT research project aims to promote the participation of (former) cancer patients in all stages of research. It was in response to the needs of the patient-researchers of the IMPAQT research group that the Perce-Neige project was developed. Based on the principles of community participation and collaboration, this project has a dual objective: methodological, aimed at understanding collaboration and characterizing the community approach, and empirical, which concerns caregivers’ perceptions of cognitive disorders related to cancer treatments. All the methodological tools aimed at meeting these objectives were co-constructed by the entire IMPAQT group. The research participation of the people concerned enables a novel way of linking expert and experiential knowledge and necessitates specific modes of organization. Also, the co-construction of research and methodological tools requires a regular updating of knowledge, as well as a capacity for reflection and an openness to reconsidering the approach. It also appears that the mobilization of the people concerned, who possess experiential knowledge, raises emotional issues. In conclusion, the participation of the people concerned in research constitutes an essential lever in the identification, elaboration, and social and psychosocial contextualization of health issues in cancerology.

Quality of life among French breast cancer survivors in comparison with cancer-free women: the Seintinelles study.

BACKGROUND: Health-Related Quality of life (HRQoL) in cancer survivors can be significantly affected in the long-term by various consequences resulting from differing levels of severity of cancer and its treatments. Our objective was to identify factors associated with HRQoL in breast cancer survivors (BCSs) and cancer-free women (CFWs). METHODS: We conducted a cross-sectional study in Seintinelles volunteers who answered online questionnaires between September 15, 2020 and February 5, 2021. HRQoL was measured using the World Health Organization Quality of Life-BREF questionnaire. We collected data on sociodemographic and health-related factors, lifestyle habits, coping mechanisms, locus of control, and health literacy. SAS version 9.4 statistical software was used for analyses. We performed descriptive analyses of the characteristics of the participants in each group and compared these characteristics between the two groups using the Chi2 test or the Student t-test. The adjusted means of the scores of different psychometric scales were calculated and compared using the method of least squares to fit general linear models (GLM) while adjusting for various factors. Multiple linear or multiple logistic regression models were used to assess the factors associated with WHOQOL-BREF scores, separately, in the two groups of participants. RESULTS: The study involved 722 BCSs and 1359 CFWs aged 26-75 years. BCSs had significantly lower physical health scores and were less likely to be satisfied with their health compared to CFWs (59.5 vs. 63.2, p < 0.0001; and 56.5% vs. 75.2%, p = 0.002, respectively). In both groups, some common factors were positively associated with physical health (high financial level, being professionally active, normal BMI, good health status, alcohol consumption, higher values (> 22) of internal locus of control); or inversely associated (neurological and sleep problems, over two medical consultations/year). In BCSs, treatment by mastectomy or radiation therapy/brachytherapy, a short-time since diagnosis, current cancer therapy, and presence of sequalae were inversely associated with physical health. BCSs' health satisfaction was diminished with lower values of coping by positive thinking (≤ 14) and seeking social support (≤ 18). CONCLUSIONS: HRQoL can be improved by developing strategies that increase internal locus of control and coping (positive thinking, problem-solving and seeking social support), and through health literacy.

Compliance with public health recommendations of cancer-free female research volunteers: the French Seintinelles study.

PURPOSE: Acting on modifiable risk factors can prevent approximately 40% of cancers. Knowing the factors that lead people to adopt healthy behaviors is crucial for designing effective primary prevention campaigns. Our study attempts to provide knowledge in this direction. METHODS: This cross-sectional study was conducted via the Seintinelles collaborative research platform in a community of women without a personal cancer history, and volunteering to take online questionnaires. We collected data on sociodemographic and health factors, knowledge of cancer risk factors, behaviors, and possible behavior changes (tobacco/alcohol use, diet, body weight, and physical activity) in the last 10 years. RESULTS: The study involved 1465 women aged between 18 and 84 years. Factors such as young age, living alone, and obesity were associated with some positive or negative behavior changes. Being professionally active and having comorbidities favored certain positive behavior changes, while having dependent children, living in a rural area, and being hospitalized were associated with negative or no change in behaviors. Lack of knowledge about modifiable risk factors for cancer was associated with the non-adoption of various healthy behaviors (consumptions of fruit and vegetables, processed and red meat; physical activity). Only 5.5% of participants currently reported to be compliant with seven public health recommendations (smoking; alcohol, fruit/vegetables, and red/processed meat intakes; body mass index; and physical activity). CONCLUSIONS: This study allowed to identify the need to increase the level of knowledge on modifiable risk factors for cancer among the general population and to better clarify the content of prevention messages.

Health behaviour changes in female cancer survivors: The Seintinelles study.

INTRODUCTION: The number of cancer survivors increases and their risks of recurrence, second cancer, morbidity and death is high; measures to prevent these risks are thus critical. Knowing the factors that lead cancer survivor to adopt or not healthy behaviours is crucial for designing effective prevention campaigns and better support them in after-cancer. Our study attempts to provide additional knowledge in this direction. METHODS: This retrospective study was conducted via the Seintinelles collaborative research platform in a community of women with cancer volunteering to take online questionnaires. We collected data on sociodemographic factors and health, knowledge of cancer risk factors, and possible behaviour changes (tobacco/alcohol use, diet, physical activity) after cancer diagnosis. RESULTS: The study involved 1180 women aged between 26 and 79 years. Several cancer-related factors (cancer other than breast cancer, longer time since diagnosis, taking drug treatment for cancer, sequelae, negative evolution of the cancer) favoured certain positive changes in behaviour. Sociodemographic factors (age, habitat environment, currently employed, living status, dependent children) or factors related to health (general condition, presence of comorbidities, neurological problems, hospitalizations, body mass index) favoured or not certain changes in behaviour. Lack of knowledge about modifiable risk factors for cancer was associated with not adopting healthy behaviours after cancer. DISCUSSION: This study made it possible to identify important elements to be addressed in order to improve cancer risk prevention messages.

A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design.

BACKGROUND: Elevated body mass index (BMI) represents a risk factor for cancer-related fatigue (CRF). Weight loss interventions are feasible and safe in cancer survivors, leading to improved cardio-metabolic and quality of life (QOL) outcomes and modulating inflammatory biomarkers. Randomized data are lacking showing that a lifestyle intervention aimed at weight loss, combining improved diet, exercise, and motivational counseling, reduces CRF. Motivating to Exercise and Diet, and Educating to healthy behaviors After breast cancer (MEDEA) is a multi-center, randomized controlled trial evaluating the impact of weight loss on CRF in overweight or obese survivors of breast cancer. Herein, we described the MEDEA methodology. METHODS: Patients (N = 220) with stage I-III breast cancer and BMI ≥ 25 kg/m2, within 12 months of primary treatment, and able to walk ≥ 400 m are eligible to enroll. Participants are randomized 1:1 to health education alone vs. a personalized telephone-based weight loss intervention plus health education. Both arms receive a health education program focusing on healthy living. Patients in the intervention arm are paired with an individual lifestyle coach, who delivers the intervention through 24 semi-structured telephone calls over 1 year. Intervention goals include weight loss ≥ 10% of baseline, caloric restriction of 500-1000 Kcal/day, and increased physical activity (PA) to 150 (initial phase) and 225-300 min/week (maintenance phase). The intervention is based on the social cognitive theory and is adapted from the Breast Cancer Weight Loss trial (BWEL, A011401). The primary endpoint is the difference in self-reported CRF (EORTC QLQ-C30) between arms. Secondary endpoints include the following: QOL (EORTC QLQ-C30, -BR45, -FA12), anxiety, and depression (HADS); weight and BMI, dietary habits and quality, PA, and sleep; health care costs (hospital-admissions, all-drug consumption, sick leaves) and cost-effectiveness (cost per quality-adjusted life-year); and patient motivation and satisfaction. The primary analysis of MEDEA will compare self-reported CRF at 12 months post-randomization between arms, with 80.0% power (two-sided α = 0.05) to detect a standardized effect size of 0.40. DISCUSSION: MEDEA will test the impact of a weight loss intervention on CRF among overweight or obese BC survivors, potentially providing additional management strategies and contributing to establish weight loss support as a new standard of clinical care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04304924.

[Citizens who volunteer as participants for cancer research-results of the Seintinelles Barometer 2018]. / Ces citoyen(nes) qui se portent volontaires pour participer aux recherches dans le champ du cancer ­ résultats du Baromètre Seintinelles 2018.

INTRODUCTION: Health researchers often face difficulties related to participants' recruitment for their research. However, a new strategy emerges: offering patients-but also citizens who are not ill-the possibility to volunteer as participants to hasten research processes. The French platform "Seintinelles" aims to fulfill this goal and bring together citizens who volunteered to participate to cancer related research. The "Seintinelles Barometer" aims to describe these volunteers' profile. METHODS: The Seintinelles Barometer data were collected through a web-based auto-questionnaire proposed to the "Seintinelles" members from June 2017 to November 2018. RESULTS: The sample presents a high level of overrepresentation of women. Participants are characterized by a high level of education. About a third of the participants had suffered from cancer. Two profile of volunteers emerged: the « patients ¼ and the « supportive citizens ¼. DISCUSSION: The Seintinelles Barometer participants manifest a strong wish to be involved in cancer related research. Therefore, this platform seems to be a promising tool for the development of community-based research in the field of cancer.