- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674515
Study of Program Interest "Bouge" to Improve the Daily Physical Activity in Processings Treatment of Non-metastatic Breast Cancer (BOUGE CANCER)
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)
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brest
-
Brest, Brest, France, 29609
- CHRU de Brest
-
-
Morlaix
-
Morlaix, Morlaix, France, 29200
- CHU de Morlaix
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
non-metastatic breast cancer start of treatment with TAXOL compatible smartphone
Exclusion Criteria:
age metastatic breast cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
Smartphone application "placebo"
|
Strategy based on smartphone application "placebo"
|
|
Active Comparator: "Bouge"
Smartphone equipped with the application "Bouge"
|
Strategy based on smartphone application "bouge"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well-being,
Time Frame: 12 weeks
|
Scale EQ-5D-5L,
|
12 weeks
|
|
Well-being,
Time Frame: 12 weeks
|
Scale EORTC QLQ-C30,
|
12 weeks
|
|
Fatigue
Time Frame: 12 weeks
|
Scale WHO
|
12 weeks
|
|
Sleep
Time Frame: 12 weeks
|
Scale SPIEGEL
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BOUGE CANCER (29BRC17.0038)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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