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

Not Applicable

• Conditions: Mobile Health Apps; Breast Cancer; Physical Activity
• Interventions: Device: Smartphone application "placebo"; Device: Smartphone equipped with application "bouge" = Coach group

• Registration Number: NCT03674515
• Lead Sponsor: University Hospital, Brest

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)

Study Timeline

• Study Start: 2017-12-15
• Study First Submitted: 2018-02-19
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-14
• Last Update Submitted: 2018-09-14
• Study First Posted: 2018-09-17
• Last Update Posted: 2018-09-17
• Primary Completion: 2018-12-12
• Study Completion: 2019-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 214

Inclusion Criteria

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

Exclusion Criteria

age metastatic breast cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Smartphone application "placebo"	Smartphone application "placebo"
"Bouge"	Smartphone equipped with application "bouge" = Coach group	Smartphone equipped with the application "Bouge"

Primary Outcome Measures

Name	Time	Method
Increased daily physical activity (number of steps) using the smartphone application "BOUGE"	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)

Secondary Outcome Measures

Name	Time	Method
Well-being,	12 weeks	Scale EORTC QLQ-C30,
Fatigue	12 weeks	Scale WHO
Sleep	12 weeks	Scale SPIEGEL

Trial Locations

Locations (2)

CHU de Morlaix; 🇫🇷 Morlaix, France

CHRU de Brest; 🇫🇷 Brest, France