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NCT03674515 Clinical Trial

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

Breast Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03674515
Other study ID # BOUGE CANCER (29BRC17.0038)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2017
Est. completion date March 15, 2019

Study information
Verified date September 2018
Source University Hospital, Brest
Contact Yannick GUILLODO
Phone 02.98.34.72.64
Email yannick.guillodo@chu-brest.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of breast cancer patients

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 214
Est. completion date March 15, 2019
Est. primary completion date December 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

non-metastatic breast cancer start of treatment with TAXOL compatible smartphone

Exclusion Criteria:

age metastatic breast cancer

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Smartphone application "placebo"
Strategy based on smartphone application "placebo"
• Smartphone equipped with application "bouge" = Coach group
Strategy based on smartphone application "bouge"

Locations
Country Name City State
France CHRU de Brest Brest
France CHU de Morlaix Morlaix

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Well-being, Scale EQ-5D-5L, 12 weeks
Secondary Well-being, Scale EORTC QLQ-C30, 12 weeks
Secondary Fatigue Scale WHO 12 weeks
Secondary Sleep Scale SPIEGEL 12 weeks
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