Advanced Breast Cancer and Lifestyle Exercise Study

Study Overview
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Brief Summary
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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.

Official Title
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Advanced Breast Cancer and Lifestyle Exercise Study

Conditions
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Metastatic Breastcancer

Intervention / Treatment
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* Other: PA intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PA intervention<br>The intervention consisted in a home-based adapted PA program defined at the inclusion, according to patient's capacities. | Other: PA intervention<br>* The program is individualized according to age, fitness level, place of residence, access to adapted specific training group or associations, PA preferences and wishes of each participant. Patients are informed of the recommendations in terms of PA, and the target of 150min per week in order to maintain health benefits. Patients are asked to walk at least 30 minutes per day and increase their activities into daily routine. Several individual strategies are established with the patients to attain their objectives and increase their daily life PA. Withings® PA trackers have been used to provide an incentive effect to increase PA, to measure the number of steps per day and make people think about their PA. Patients wore a Withings Go® wristband PA tracker throughout the whole study and had in real time a feedback on their number of steps per day. A 7 mL blood sample is collected at baseline (D1) and at the end of the 6-month study (M6) for the biological study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving the physical activity program recommendations | 150 min per week of moderate PA assessed by the IPAQ | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of oxidative stress | 7mL blood sample is collected at baseline and at the end of the study | 6 months | 
| Investigate the effects of a PA intervention on fitness level | IPAQ in MET-min per week | 6 months | 
| Investigate the effects of a PA intervention on fitness level | 6-min walk test in meters | 6 months | 
| Investigate the effects of a PA intervention on fitness level | VO2 peak in ml per kg per minute | 6 months | 
| Investigate the effects of a PA intervention on fitness level | strength test in kilograms | 6 months | 
| Investigate the effects of a PA intervention on quality of life | EORTC QLQ-C30 | 6 months | 
| Investigate the effects of a PA intervention on quality of life | BR-23 | 6 months | 
| Investigate the effects of a PA intervention on fatigue | PIPER scale | 6 months | 
| Investigate the effects of a PA intervention on social deprivation | EPICES score | 6 months | 
| Investigate the barriers and facilitators of adherence to a PA program | Specific questionnaire | 6 months | 
| Investigate the effects of a PA intervention on changes in anthropometrics | BMI in kilograms per m² | 6 months | 
| Investigate the effects of a PA intervention on changes in anthropometrics | waist circumference in centimeters | 6 months | 
| Investigate the effects of a PA intervention on changes in anthropometrics | Weight in kilograms | 6 months | 
| Investigate the effects of a PA intervention on changes in anthropometrics | Hip circumference in centimeters | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity