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

September 14, 2018 updated by: University Hospital, Brest

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)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

age metastatic breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Smartphone application "placebo"
Device: Smartphone application "placebo"
Strategy based on smartphone application "placebo"
Active Comparator: "Bouge"
Smartphone equipped with the application "Bouge"
Device: Smartphone equipped with application "bouge" = Coach group
Strategy based on smartphone application "bouge"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Well-being,
Time Frame: 12 weeks
Scale EQ-5D-5L,
12 weeks
Well-being,
Time Frame: 12 weeks
Scale EORTC QLQ-C30,
12 weeks
Fatigue
Time Frame: 12 weeks
Scale WHO
12 weeks
Sleep
Time Frame: 12 weeks
Scale SPIEGEL
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Anticipated)

December 12, 2018

Study Completion (Anticipated)

March 15, 2019

Study Registration Dates

First Submitted

February 19, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (Actual)

September 17, 2018

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 14, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOUGE CANCER (29BRC17.0038)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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