Study of Program Interest Bouge to Improve the Daily Physical Activity in Processings Treatment of Non-metastatic Breast Cancer

Study Overview
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Brief Summary
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Evaluate the Bouge digital program (smartphone application) to increase the daily physical activity of breast cancer patients

Detailed Description
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Controlled, randomized, open, prospective, multicentric study, 214 volunteer patients aged between 18 and 70, with breast cancer, at the start of TAXOL treatment, possessing a smartphone, will be recruited and randomized into two groups: 107 in the control group (smartphone application placebo = number of steps) 107 will be equipped with the application Bouge = coached group For three months, the patients do their daily physical activity. The coached group, through the smartphone application Bouge, receives computer coaching to increase their physical activity (no direct medical intervention, only notifications and computer pusch). The control group is not coached by the application (simple display of the number of step)

Official Title
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Study of Program Interest Bouge to Improve the Daily Physical Activity and Tolerance in Processings Treatment of Non-metastatic Breast Cancer at the Beginning Weekly Taxol Adjuvant Chemotherapy (Www.Bouge-coaching.Com)

Conditions
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Physical Activity, Breast Cancer, Mobile Health Apps

Intervention / Treatment
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* Device: Smartphone application placebo
* Device: Smartphone equipped with application bouge = Coach group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-metastatic breast cancer start of treatment with TAXOL compatible smartphone Exclusion Criteria: age metastatic breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Smartphone application placebo | Device: Smartphone application placebo<br>* Strategy based on smartphone application placebo<br>|
| Active Comparator: Bouge<br>Smartphone equipped with the application Bouge | Device: Smartphone equipped with application bouge = Coach group<br>* Strategy based on smartphone application bouge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased daily physical activity (number of steps) using the smartphone application BOUGE | The objective is an increase of 3000 steps daily between J 1 and J 90 (an increase of 15 000 steps between S1 and S 12) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being, | Scale EQ-5D-5L, | 12 weeks | 
| Well-being, | Scale EORTC QLQ-C30, | 12 weeks | 
| Fatigue | Scale WHO | 12 weeks | 
| Sleep | Scale SPIEGEL | 12 weeks |