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Clinical Trials/NCT03674515
NCT03674515TerminatedNot Applicable

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)

University Hospital, Brest2 sites in 1 country23 target enrollmentStarted: December 14, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
23
Locations
2
Primary Endpoint
Increased daily physical activity (number of steps) using the smartphone application "BOUGE"

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •age metastatic breast cancer

Arms & Interventions

"Bouge"

Active Comparator

Smartphone equipped with the application "Bouge"

Intervention: Smartphone equipped with application "bouge" = Coach group (Device)

placebo

Placebo Comparator

Smartphone application "placebo"

Intervention: Smartphone application "placebo" (Device)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Well-being,(12 weeks)
  • Fatigue(12 weeks)
  • Sleep(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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