A Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Registration Number
- NCT04354233
- Lead Sponsor
- Centre Leon Berard
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - <br><br> 1) female,<br><br> - <br><br> 2) = 18 years old,<br><br> - <br><br> 3) histologically confirmed metastatic breast cancer, with at least one positive<br> hormone receptor (HR+) and HER2-,<br><br> - <br><br> 4) first-line chemotherapy planned (or until 1 month after the chemotherapy has<br> started) with intravenous (Paclitaxel or Doxorubicin or Cyclophosphamide or<br> Carboplatin) or per os (Capecitabine or Vinorelbine) administration - NB : a<br> patient who has previously received one or more lines of hormone therapy and<br> who must start a 1st line of chemotherapy is eligible,<br><br> - <br><br> 5) Eastern Cooperative Oncology Group (ECOG) Performance status = 2,<br><br> - <br><br> 6) life expectancy = 3 months,<br><br> - <br><br> 7) willing to be involved throughout the study,<br><br> - <br><br> 8) ability to practice a adapted physical activity (APA) certified by a medical<br> certificate issued by the referring oncologist or the clinical investigator,<br><br> - <br><br> 9) using a compatible smartphone or Tablet PC to download the application ABLE02<br> and Withings Health Mate (from iOS 10 and android 6.0 and more recent),<br><br> - <br><br> 10) Internet access,<br><br> - <br><br> 11) valid health insurance affiliation,<br><br> - <br><br> 12) able to read, write and understand French.<br><br>Exclusion Criteria:<br><br> - <br><br> 1) presence of unstable bone metastases or unconsolidated pathological fractures,<br><br> - <br><br> 2) presence of central nervous system involvement with neurological deficits that<br> prevent from walking,<br><br> - <br><br> 3) presence of a history or co-existence of other primary cancer (except of in<br> situ cancer regardless of the site and/or basal cell skin cancer and/or<br> non-mammary cancer in complete remission for more than 5 years),<br><br> - <br><br> 4) severe undernutrition (HAS) (i.e. for women = 70 years old: a weight loss of =<br> 15% in 6 months or =10% in 1 month and for women over 70 years old: a weight<br> loss of = 15% in 6 months or =10% in 1 month, and body mass index <18 kg/m²),<br><br> - <br><br> 5) presenting a PA contraindication (e.g., uncontrolled hypertension, uncontrolled<br> heart disease),<br><br> - <br><br> 6) concurrent participation in another PA study,<br><br> - <br><br> 7) unable to be followed for medical, social, family, geographical or<br> psychological reasons throughout the study,<br><br> - <br><br> 8) deprived of liberty by judicial or administrative decision,<br><br> - <br><br> 9) pregnant.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to deterioration of global health status (GHS) score of EORTC QLQ C30;time to deterioration of fatigue score of EORTC QLQ C30
- Secondary Outcome Measures
Name Time Method