Advanced Breast Cancer and Lifestyle Exercise Study
- Conditions
- Metastatic Breastcancer
- Interventions
- Other: PA intervention
- Registration Number
- NCT03148886
- Lead Sponsor
- Centre Leon Berard
- Brief Summary
About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer become secondarily metastatic.Thanks to recent therapeutic advances, the median survival ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The physical, biological, psychological and clinical benefits of physical activity (PA) during treatment in patients with localized breast cancer have been widely demonstrated. Numerous studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge, only four interventional studies worldwide focused on the implementation of PA in patients with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA intervention with patients with metastatic breast cancer to see if the observed effects in localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study is an interventional cohort designed to assess the feasibility of a 6-month adapted physical activity intervention, performed under real life conditions in patients with metastatic breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 51
- aged 18 to 78 years old,
- newly diagnosed with a metastatic breast cancer (i.e. within the last 3 months)
- treated in the CLB by chemotherapy, and/or radiotherapy and/or hormonotherapy and/or targeted therapy.
- ECOG Performance status <2,
- being French-speaking
- able to complete questionnaires and follow instructions in French
- valid health insurance affiliation.
- medical certificate of no contraindications to exercise physical activity
- untreated brain metastases
- uncontrolled cardiac disease,
- contraindications to PA,
- unable to be followed for medical, social, familial, geographical or psychological reasons over the study duration,
- deprivation of liberty by court or administrative decision
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PA intervention PA intervention The intervention consisted in a home-based adapted PA program defined at the inclusion, according to patient's capacities.
- Primary Outcome Measures
Name Time Method Proportion of patients achieving the physical activity program recommendations 6 months 150 min per week of moderate PA assessed by the IPAQ
- Secondary Outcome Measures
Name Time Method Investigate the effects of a PA intervention on fatigue 6 months PIPER scale
Investigate the effects of a PA intervention on changes in anthropometrics 6 months Hip circumference in centimeters
Variation of oxidative stress 6 months 7mL blood sample is collected at baseline and at the end of the study
Investigate the effects of a PA intervention on fitness level 6 months strength test in kilograms
Investigate the effects of a PA intervention on quality of life 6 months BR-23
Investigate the effects of a PA intervention on social deprivation 6 months EPICES score
Investigate the barriers and facilitators of adherence to a PA program 6 months Specific questionnaire
Trial Locations
- Locations (1)
Centre Léon Bérard
🇫🇷Lyon, France