About this trial
Adapted physical activity (APA) was recognized as a non-drug therapy by the French Health Authority (HAS) in 2011. Very few studies have examined the efficiency of APA programs during the active phase of treatment in cancer patients. The investigators assumed that non-drug therapy such as APA could improve the quality of life and reduces health costs. The main objective of this study is to assess the efficiency of a standardized APA program, as compared to conventional management including simple recommendations for the practice of physical activity in women in phase active breast cancer treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
women with breast cancer
any type of breast cancer, all grades, all stages
during treatment: surgery +/- chemotherapy +/- radiotherapy +/- hormone therapy
Disqualifiers
World Health Organization (WHO) 4
Unstable angina
Uncontrolled Atrial fibrillation
Uncontrolled high blood pressure
Trial design
Parallel
Treatments tested in this trial
APA Program
Other interventionPatients treated and monitored for their breast cancer following the 6-month APA program.
Recommendations for physical activity
Other interventionPatients treated and monitored for their breast cancer who have received recommendations for physical activity as well as a 6-month activity schedule. To facilitate patient acceptance and participation in this study, patients who will be randomized to the control group will be offered to follow the APA program after one year of inclusion
Treatment groups
Trial outcomes
Primary outcomes
Comparison of physical activity programmes
Evaluation of the differential cost-utility ratio (cost / QALY), according to the perspective of the community over a 12-month period, of an adapted physical activity program (APA) in comparison to conventional care, including simple recommendations for physical activity for patients with breast cancer during the active phase of treatment.
Secondary outcomes
Breast cancer-specific quality of life
Breast Cancer Specific Quality of Life Questionnaire (QLQ) (BR23-QLQ-C30) is a 52-item questionnaire. The choices range from 1 "not at all" to 4 "very much".
Clinical efficacy
Progression-free survival measured for non-metastatic (relapse-free survival) and metastatic (progression-free survival) patients
Efficacy on specific functions
BR23-QLQ-C30 questionnaire. Breast Cancer Specific Quality of Life Questionnaire (BR23-QLQ-C30) is a 52-item questionnaire. The choices range from 1 "not at all" to 4 "very much".
Society impact (interview)
Zarit-Burden Interview
Sponsors and contacts
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