NCT03674515

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

February 19, 2018

Last Update Submit

September 14, 2018

Conditions

Physical ActivityBreast CancerMobile Health Apps

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Well-being,

    12 weeks

  • Well-being,

    12 weeks

  • Fatigue

    12 weeks

  • Sleep

    12 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

Smartphone application "placebo"

Device: Smartphone application "placebo"

"Bouge"

ACTIVE COMPARATOR

Smartphone equipped with the application "Bouge"

Device: Smartphone equipped with application "bouge" = Coach group

Interventions

Smartphone application "placebo"DEVICE

Strategy based on smartphone application "placebo"

placebo
Smartphone equipped with application "bouge" = Coach groupDEVICE

Strategy based on smartphone application "bouge"

"Bouge"

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • age metastatic breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Brest

Brest, 29609, France

RECRUITING

CHU de Morlaix

Morlaix, 29200, France

RECRUITING

MeSH Terms

Conditions

Motor ActivityBreast Neoplasms

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yannick GUILLODO

CONTACT

02.98.34.72.64yannick.guillodo@chu-brest.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

September 17, 2018

Study Start

December 15, 2017

Primary Completion

December 12, 2018

Study Completion

March 15, 2019

Last Updated

September 17, 2018

Record last verified: 2018-09

Locations

FR(2)