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

NCT ID: NCT03674515

Last Updated: 2018-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2019-03-15

Brief Summary

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

Detailed Description

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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)

Conditions

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Physical Activity Breast Cancer Mobile Health Apps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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placebo

Smartphone application "placebo"

Group Type PLACEBO_COMPARATOR

Smartphone application "placebo"

Intervention Type DEVICE

Strategy based on smartphone application "placebo"

"Bouge"

Smartphone equipped with the application "Bouge"

Group Type ACTIVE_COMPARATOR

Smartphone equipped with application "bouge" = Coach group

Intervention Type DEVICE

Strategy based on smartphone application "bouge"

Interventions

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Smartphone application "placebo"

Strategy based on smartphone application "placebo"

Intervention Type DEVICE

Smartphone equipped with application "bouge" = Coach group

Strategy based on smartphone application "bouge"

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

age metastatic breast cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Brest

Brest, , France

Site Status RECRUITING

CHU de Morlaix

Morlaix, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Yannick GUILLODO

Role: CONTACT

02.98.34.72.64

Facility Contacts

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Hélène SIMON

Role: primary

Matthieu MULLER

Role: primary

Other Identifiers

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BOUGE CANCER (29BRC17.0038)

Identifier Type: -

Identifier Source: org_study_id

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