NCT03674515

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

2 active sites

Status
terminated

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 14, 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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2018

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

11 months

First QC Date

February 19, 2018

Last Update Submit

June 5, 2026

Conditions

Physical ActivityMobile Health AppsBreast Cancer

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 equipped with application "bouge" = Coach groupDEVICE

Strategy based on smartphone application "bouge"

"Bouge"
Smartphone application "placebo"DEVICE

Strategy based on smartphone application "placebo"

placebo

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, Brest, 29609, France

Location

CHU de Morlaix

Morlaix, Morlaix, 29200, France

Location

MeSH Terms

Conditions

Motor ActivityBreast Neoplasms

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

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 14, 2017

Primary Completion

November 12, 2018

Study Completion

November 12, 2018

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations

FR(2)