Feasibility Study to Assess the Impact of a Lifestyle Intervention during Colorectal Cancer Screening in France.

Current evidence suggests that 30-50% of cancers are attributable to established lifestyle risk factors. Cancer-screening has been identified as an opportunity for delivering advice on lifestyle behaviour change for cancer prevention. This study aimed to evaluate the feasibility and acceptance of promoting advice on the latest evidence-based lifestyle recommendations for cancer prevention at the time of colorectal cancer screening at two hospitals in Lyon, France. This feasibility study included 49 patients (20 men and 29 women) who were invited for colonoscopy. Patients received a leaflet with lifestyle recommendations for cancer prevention, accompanied with a logbook to plan and monitor their behavioural changes. Feedback from patients, hospital staff, and researchers was received via evaluation questionnaires (n = 26) completed after testing the educational material for at least two weeks and via two focus group discussions (n = 7 and n = 9 respectively) organized at the end of the study. All interviewed patients were interested in lowering their cancer risk, and the majority felt ready to change their lifestyle (88%), although most did not know how to decrease their risk of cancer (61%). All patients found the educational material easy to understand and sufficiently attractive and 50% of the patients reported having achieved at least one of the healthy behaviours recommended within the two weeks following the intervention. All hospital staff and almost all patients (92%) involved found that the screening program and the visits planned for colonoscopy was an appropriate moment to provide them with the educational material. This feasibility study has shown that the content, paper-based format, and time of delivery of the intervention were adequate. Health professionals seem to be willing to provide lifestyle recommendations, and patients appear interested in receiving advice for lowering their cancer risk during screening visits.

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.

Individualised physical activity programme in patients over 65 years with haematological malignancies (OCAPI): protocol for a single-arm feasibility trial.

INTRODUCTION: Older adults with cancer suffer from the combined effects of ageing, cancer disease and treatment side effects. The main treatment for patients with haematological malignancies is chemotherapy, associated with significant toxicities. Chemotherapy can alter patients' physical function and quality of life which are often already diminished in older patients due to ageing and comorbidities. It therefore seems essential to develop and to evaluate interventions capable of preventing physical and psychosocial decline and its consequences. Promoting physical activity is a promising approach to improve physical function and quality of life in older adults with cancer, but there are limited data on the feasibility of such interventions among older patients with haematological malignancies, concomitant to chemotherapy. METHODS AND ANALYSIS: OCAPI (OnCogeriatric and Individualized Physical Activity) is a single-arm, interdisciplinary, prospective, interventional, feasibility study. It is intended to include 40 patients (20 patients with acute myeloid leukaemia and 20 patients with non-Hodgkin's lymphoma) over 65 years in an individualised 6-month physical activity programme. The programme consists of individually supervised exercise sessions with an increasing volume of physical activity either at home and/or in a laminar airflow room (depending on the disease and treatment regimen) followed by unsupervised sessions and phone follow-ups. Patients will receive an activity tracker during the 6 months of the programme. Evaluations will take place at inclusion and at 3, 6 and 12 months to assess the feasibility of the programme and to explore potential changes in physical, psychosocial and clinical outcomes. The results will generate preliminary data to implement a larger randomised controlled trial. ETHICS AND DISSEMINATION: The study protocol was approved by the French ethics committee (Comité de protection des personnes Est I, N°ID-RCB 2019-A01231-56, 12 July 2019). All participants will have to sign and date an informed consent form. The findings will be disseminated in peer-reviewed journals and academic conferences. TRIAL REGISTRATION NUMBER: NCT04052126.

Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial.

BACKGROUND: Patients with a metastatic breast cancer suffer from a deteriorated health-related quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program using connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer. METHODS: ABLE02 is a prospective, national, multicenter, randomized, controlled and open-label study. A total of 244 patients with a metastatic breast cancer, with at least one positive hormone receptor and a first-line chemotherapy planned, will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 h a day during the whole intervention (6 months) with at least three weekly walking sessions and quizzes each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Health-related quality of life will be assessed every 6 weeks and main assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application. DISCUSSION: An activity program based on a smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors. TRIAL REGISTRATION: NCT number: NCT04354233 .

Assessment of sedentary behaviors and transport-related activities by questionnaire: a validation study.

BACKGROUND: Comprehensive assessment of sedentary behavior (SB) and physical activity (PA), including transport-related activities (TRA), is required to design innovative PA promotion strategies. There are few validated instruments that simultaneously assess the different components of human movement according to their context of practice (e.g. work, transport, leisure). We examined test-retest reliability and validity of the Sedentary, Transportation and Activity Questionnaire (STAQ), a newly developed questionnaire dedicated to assessing context-specific SB, TRA and PA. METHODS: Ninety six subjects (51 women) kept a contextualized activity-logbook and wore a hip accelerometer (Actigraph GT3X + (TM)) for a 7-day or 14-day period, at the end of which they completed the STAQ. Activity-energy expenditure was measured in a subgroup of 45 subjects using the double labeled water (DLW) method. Test-retest reliability was assessed using intra-class-coefficients (ICC) in a subgroup of 32 subjects who filled the questionnaire twice one month apart. Accelerometry was annotated using the logbook to obtain total and context-specific objective estimates of SB. Spearman correlations, Bland-Altman plots and ICC were used to analyze validity with logbook, accelerometry and DLW data validity criteria. RESULTS: Test-retest reliability was fair for total sitting time (ICC = 0.52), good to excellent for work sitting time (ICC = 0.71), transport-related walking (ICC = 0.61) and car use (ICC = 0.67), and leisure screen-related SB (ICC = 0.64-0.79), but poor for total sitting time during leisure and transport-related contexts. For validity, compared to accelerometry, significant correlations were found for STAQ estimates of total (r = 0.54) and context-specific sitting times with stronger correlations for work sitting time (r = 0.88), and screen times (TV/DVD viewing: r = 0.46; other screens: r = 0.42) than for transport (r = 0.35) or leisure-related sitting-times (r = 0.19). Compared to contextualized logbook, STAQ estimates of TRA was higher for car (r = 0.65) than for active transport (r = 0.41). The questionnaire generally overestimated work- and leisure-related SB and sitting times, while it underestimated total and transport-related sitting times. CONCLUSIONS: The STAQ showed acceptable reliability and a good ranking validity for assessment of context-specific SB and TRA. This instrument appears as a useful tool to study SB, TRA and PA in context in adults.

Automatic identification of physical activity types and sedentary behaviors from triaxial accelerometer: laboratory-based calibrations are not enough.

"Objective" methods to monitor physical activity and sedentary patterns in free-living conditions are necessary to further our understanding of their impacts on health. In recent years, many software solutions capable of automatically identifying activity types from portable accelerometry data have been developed, with promising results in controlled conditions, but virtually no reports on field tests. An automatic classification algorithm initially developed using laboratory-acquired data (59 subjects engaging in a set of 24 standardized activities) to discriminate between 8 activity classes (lying, slouching, sitting, standing, walking, running, and cycling) was applied to data collected in the field. Twenty volunteers equipped with a hip-worn triaxial accelerometer performed at their own pace an activity set that included, among others, activities such as walking the streets, running, cycling, and taking the bus. Performances of the laboratory-calibrated classification algorithm were compared with those of an alternative version of the same model including field-collected data in the learning set. Despite good results in laboratory conditions, the performances of the laboratory-calibrated algorithm (assessed by confusion matrices) decreased for several activities when applied to free-living data. Recalibrating the algorithm with data closer to real-life conditions and from an independent group of subjects proved useful, especially for the detection of sedentary behaviors while in transports, thereby improving the detection of overall sitting (sensitivity: laboratory model = 24.9%; recalibrated model = 95.7%). Automatic identification methods should be developed using data acquired in free-living conditions rather than data from standardized laboratory activity sets only, and their limits carefully tested before they are used in field studies.

Estimation of physical activity monitored during the day-to-day life by an autonomous wearable device (SVELTE project).

Physical activity (PA) and the energy expenditure it generates (PAEE) are increasingly shown to have impacts on everybody's health (e.g. development of chronic diseases) and to be key factors in maintaining the physical autonomy of elderlies. The SVELTE project objective was to develop an autonomous actimeter, easily wearable and with several days of autonomy, which could record a subject's physical activity during his/her daily life and estimate the associated energy expenditure. A few prototypes and dedicated algorithms were developed based on laboratory experiments. The identification of physical activity patterns algorithm shows good performances (79% of correct identification), based on a trial in semi-free-living conditions. The assessment of the PAEE computation algorithm is under validation based on a clinical trial.