Design of a Randomised Controlled Trial of Adapted Physical Activity During Adjuvant Treatment for Localised Breast Cancer: the PASAPAS Feasibility Study
Total Page:16
File Type:pdf, Size:1020Kb
Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2013-003855 on 28 October 2013. Downloaded from Design of a randomised controlled trial of adapted physical activity during adjuvant treatment for localised breast cancer: the PASAPAS feasibility study M Touillaud,1 A-M Foucaut,1,2 S E Berthouze,2 E Reynes,2 A-S Kempf-Lépine,1 J Carretier,1,3 D Pérol,4 S Guillemaut,4 S Chabaud,4 V Bourne-Branchu,4 L Perrier,1,5 O Trédan,6 B Fervers,1,3 P Bachmann7 To cite: Touillaud M, ABSTRACT ARTICLE SUMMARY Foucaut A-M, Berthouze SE, Introduction: After a diagnosis of localised breast et al . Design of a randomised cancer, overweight, obesity and weight gain are controlled trial of adapted Strengths and limitations of this study negatively associated with prognosis. In contrast, physical activity during ▪ This study will provide feasibility of implement- adjuvant treatment for maintaining an optimal weight through a balanced diet ing an innovative 6-month programme of localised breast cancer: the combined with regular physical activity appears to be adapted physical activity during breast cancer PASAPAS feasibility study. effective protective behaviour against comorbidity or treatment for a future full-scale randomised con- BMJ Open 2013;3:e003855. mortality after a breast cancer diagnosis. The primary trolled trial testing the effectiveness of physical doi:10.1136/bmjopen-2013- aim of the Programme pour une Alimentation Saine et activity on survival-related outcomes. 003855 une Activité Physique Adaptée pour les patientes ▪ The physical activity programme presented has atteintes d’un cancer du Sein (PASAPAS) randomised the advantage of being performed during breast ▸ Prepublication history for controlled trial is to evaluate the feasibility of cancer adjuvant treatment, personalised and this paper is available online. implementing an intervention of adapted physical activity supervised by trained professionals. It reflects To view these files please (APA) for 6 months concomitant with the prescription growing evidence showing the necessity to visit the journal online of a first line of adjuvant chemotherapy. Secondary aims maintain or start physical activity as soon as (http://dx.doi.org/10.1136/ include assessing the acceptability of the intervention, possible after a cancer diagnosis and avoid loss bmjopen-2013-003855). http://bmjopen.bmj.com/ compliance to the programme, process implementation, of physical fitness. patients’ satisfaction, evolution of biological parameters ▪ Received 20 August 2013 As in most feasibility studies, the sample size is Accepted 25 September 2013 and the medicoeconomic impact of the intervention. small but it is sufficient to test procedure Methods and analysis: The study population consists adequacy for formalising the design of a defini- of 60 women eligible for adjuvant chemotherapy after a tive trial. diagnosis of localised invasive breast cancer. They will be recruited during a 2-year inclusion period and randomly allocated between an APA intervention arm INTRODUCTION and a control arm following a 2:1 ratio. All participants Throughout the world, breast cancer is the on September 24, 2021 by guest. Protected copyright. should benefit from personalised dietetic counselling leading cause of cancer in women and the and patients allocated to the intervention arm will be offered an APA programme of two to three weekly leading cause of cancer death, with sessions of Nordic walking and aerobic fitness. During c.1 383 500 new cases and 458 400 deaths in 1 the 6-month intervention and 6-month follow-up, four 2008. Thanks to progress in diagnostic tools, assessments will be performed including blood draw, care and treatments in Western countries, sur- anthropometrics and body composition measurements, vival after diagnosis is greater than 80% at and questionnaires about physical activity level, diet, 5years.2 Overall, breast cancer seems to be a lifestyle factors, psychological criteria, satisfaction with disease of the developed world and particu- the intervention and medical data. larly affects Western countries or those with a Ethics and dissemination: The study was approved Western lifestyle. Therefore, it is important for by the French Ethics Committee (Comité de Protection patients with breast cancer and survivors to des Personnes Sud-Est IV) and the national agencies for maintain optimal health and minimise the For numbered affiliations see biomedical studies and for privacy. All participants will end of article. deleterious effects of cancer and its treatment give written informed consent. The study findings will be such as fatigue, stress, anxiety or obesity. disseminated through the scientific public and serve as a 3 Correspondence to foundation for future randomised controlled trials of Weight gain in adulthood, overweight, 4 Dr Patrick Bachmann; efficacy. obesity, as well as lack of physical activity patrick.bachmann@lyon. (PA)5 and alcohol consumption are risk unicancer.fr Touillaud M, Foucaut A-M, Berthouze SE, et al. BMJ Open 2013;3:e003855. doi:10.1136/bmjopen-2013-003855 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2013-003855 on 28 October 2013. Downloaded from factors commonly associated with risk of breast cancer (ie, non-metastatic) breast cancer, the feasibility of (mainly in postmenopause for overweight and obesity).6 implementing an APA intervention for 6 months, in add- After a diagnosis of breast cancer, obesity appears to ition to a dietary management, concomitant with the double the risk of recurrence and death in these patients, prescription of a first line of adjuvant chemotherapy regardless of the state of menopause.78Weight gain after (which lasts between 12 and 18 weeks according to the diagnosis is also recognised as a risk factor for increased protocol). The secondary objectives are to: (1) assess the risk of recurrence and mortality and increases the risk of acceptability of the intervention and randomisation and comorbidities.89In contrast, PA performed appropriately the recruiting capabilities; (2) assess the patients’ adher- could improve many prognostic factors as well as survival ence to the intervention programme and analyse the in women after breast cancer. Several large cohort studies reasons for non-adherence; (3) verify the adequacy of women with breast cancer have shown an average between the procedures of the intervention programme reduction of 45% mortality associated with moderate (APA and dietetic), as well as the data collection and – exercise compared to a sedentary lifestyle.10 14 management, and the constraints of implementing the Randomised control trials have also shown that PA study in real conditions; (4) describe the patients’ satis- improves fitness, quality of life, self-esteem and treatment faction with the dietetic and APA programmes; adherence and reduces fatigue.71516Thus, maintaining (5) perform a health economics analysis; (6) describe an optimal weight through a balanced diet combined the baseline state and evolution of a number of variables with regular PA appears to be effective protective behav- (PA level and profile, dietary intake, anthropometrics, iour against breast cancer as well as comorbidity or mor- body composition, lipid profiles, quality of life, body tality after a diagnosis of breast cancer.11 satisfaction/self-perception, self-esteem, depression, Observational cohorts of patients with breast cancer anxiety); (7) finally, as part of a joint biological study, conducted in France have shown that currently almost describe the metabolomic profiles, lipidomic profiles, as half of the French patients are overweight or obese at well as the expression of endocrine factors and diagnosis,917and that nearly half of them gain weight adipokines linked to breast cancer at initial diagnosis within 1 year after chemotherapy.17 Patients treated for (ie, comparing between tumour and circulating blood breast cancer practice less physical exercise of moderate before surgery in a cross-sectional study) and metabolic to vigorous intensity than the healthy population for a changes during the interventions (longitudinal study). similar energy expenditure.18 Indeed, reduced PA is a factor that is most likely implicated in weight gain METHODS AND DESIGN among women receiving adjuvant chemotherapy for – Study design localised breast cancer.19 21 Given the poor prognosis fi The PASAPAS study is an interventional, controlled, ran- associated with overweight, weight gain and insuf cient http://bmjopen.bmj.com/ domised, single-centre, open-label, parallel-group study PA, supportive care including PA and dietetic care is with two arms: an intervention (or ‘APA’) group where necessary in patients with breast cancer. patients are invited to a 6-month exercise programme in Despite the encouraging results of mainly North supervised groups in addition to the usual and persona- American studies on the impact of PA after breast lised dietetic care; a control group receiving the usual cancer, no intervention studies of PA were conducted dietetic care and PA national guidelines. The 6-month until recently in France.22 Therefore, our aim was to intervention is followed by a 6-month monitoring, that is transpose the international evidence to the French a 12-month study duration for each participant. The population and context, given the major cultural differ- on September 24, 2021 by guest. Protected copyright. enrolment is planned over a period of 24 months, which ences concerning food, the practice of PA and other corresponds to a total study