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Trial record 90 of 3068 for:    Recruiting, Not yet recruiting, Available Studies | Physical

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

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ClinicalTrials.gov Identifier: NCT03674515
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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

Condition or disease Intervention/treatment Phase
Physical Activity Breast Cancer Mobile Health Apps Device: Smartphone application "placebo" Device: Smartphone equipped with application "bouge" = Coach group Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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)
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 12, 2018
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


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"




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Well-being, [ Time Frame: 12 weeks ]
    Scale EQ-5D-5L,

  2. Well-being, [ Time Frame: 12 weeks ]
    Scale EORTC QLQ-C30,

  3. Fatigue [ Time Frame: 12 weeks ]
    Scale WHO

  4. Sleep [ Time Frame: 12 weeks ]
    Scale SPIEGEL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

age metastatic breast cancer


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674515


Contacts
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Contact: Yannick GUILLODO 02.98.34.72.64 yannick.guillodo@chu-brest.fr

Locations
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France
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Hélène SIMON       helene.simon@chu-brest.fr   
CHU de Morlaix Recruiting
Morlaix, France, 29200
Contact: Matthieu MULLER       m.muller@ch-morlaix.fr   
Sponsors and Collaborators
University Hospital, Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03674515     History of Changes
Other Study ID Numbers: BOUGE CANCER (29BRC17.0038)
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases