Study of Program Interest "Bouge" to Improve the Daily Physical Activity in Processings Treatment of Non-metastatic Breast Cancer (BOUGE CANCER)
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|ClinicalTrials.gov Identifier: NCT03674515|
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity Breast Cancer Mobile Health Apps||Device: Smartphone application "placebo" Device: Smartphone equipped with application "bouge" = Coach group||Not Applicable|
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||214 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||December 15, 2017|
|Estimated Primary Completion Date :||December 12, 2018|
|Estimated Study Completion Date :||March 15, 2019|
Placebo Comparator: placebo
Smartphone application "placebo"
Device: Smartphone application "placebo"
Strategy based on smartphone application "placebo"
Active Comparator: "Bouge"
Smartphone equipped with the application "Bouge"
Device: Smartphone equipped with application "bouge" = Coach group
Strategy based on smartphone application "bouge"
- Increased daily physical activity (number of steps) using the smartphone application "BOUGE" [ Time Frame: 12 weeks ]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)
- Well-being, [ Time Frame: 12 weeks ]Scale EQ-5D-5L,
- Well-being, [ Time Frame: 12 weeks ]Scale EORTC QLQ-C30,
- Fatigue [ Time Frame: 12 weeks ]Scale WHO
- Sleep [ Time Frame: 12 weeks ]Scale SPIEGEL
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674515
|Contact: Yannick GUILLODOfirstname.lastname@example.org|