Back to resultsStudy of Program Interest "Bouge" to Improve the Daily Physical Activity in Processings Treatment of Non-metastatic Breast Cancer (BOUGE CANCER)
Primary Purpose
Physical Activity, Breast Cancer, Mobile Health Apps
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Smartphone application "placebo"
Smartphone equipped with application "bouge" = Coach group
Sponsored by
About this trial
This is an interventional other trial for Physical Activity
Eligibility Criteria
Inclusion Criteria:
non-metastatic breast cancer start of treatment with TAXOL compatible smartphone
Exclusion Criteria:
age metastatic breast cancer
Sites / Locations
- CHRU de BrestRecruiting
- CHU de MorlaixRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
"Bouge"
Arm Description
Smartphone application "placebo"
Smartphone equipped with the application "Bouge"
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Well-being,
Scale EQ-5D-5L,
Well-being,
Scale EORTC QLQ-C30,
Fatigue
Scale WHO
Sleep
Scale SPIEGEL
Full Information
NCT ID
NCT03674515
First Posted
February 19, 2018
Last Updated
September 14, 2018
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT03674515
Brief Title
Study of Program Interest "Bouge" to Improve the Daily Physical Activity in Processings Treatment of Non-metastatic Breast Cancer
Acronym
BOUGE CANCER
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
December 12, 2018 (Anticipated)
Study Completion Date
March 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of breast cancer patients
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Breast Cancer, Mobile Health Apps
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Smartphone application "placebo"
Arm Title
"Bouge"
Arm Type
Active Comparator
Arm Description
Smartphone equipped with the application "Bouge"
Intervention Type
Device
Intervention Name(s)
Smartphone application "placebo"
Intervention Description
Strategy based on smartphone application "placebo"
Intervention Type
Device
Intervention Name(s)
Smartphone equipped with application "bouge" = Coach group
Intervention Description
Strategy based on smartphone application "bouge"
Primary Outcome Measure Information:
Title
Increased daily physical activity (number of steps) using the smartphone application "BOUGE"
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Well-being,
Description
Scale EQ-5D-5L,
Time Frame
12 weeks
Title
Well-being,
Description
Scale EORTC QLQ-C30,
Time Frame
12 weeks
Title
Fatigue
Description
Scale WHO
Time Frame
12 weeks
Title
Sleep
Description
Scale SPIEGEL
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
non-metastatic breast cancer start of treatment with TAXOL compatible smartphone
Exclusion Criteria:
age metastatic breast cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yannick GUILLODO
Phone
02.98.34.72.64
Email
yannick.guillodo@chu-brest.fr
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène SIMON
Email
helene.simon@chu-brest.fr
Facility Name
CHU de Morlaix
City
Morlaix
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu MULLER
Email
m.muller@ch-morlaix.fr
12. IPD Sharing Statement
Learn more about this trial
Study of Program Interest "Bouge" to Improve the Daily Physical Activity in Processings Treatment of Non-metastatic Breast Cancer
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