Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer

Summary

The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

Conditions

• Breast Cancer

Interventions

DEVICE

Connected device

Women will receive a connected wristband (https://www.carefitness.com/) and a subscription to a smartphone application and website (http://disco.biomouv.com/). They will have to participate in a 6-month personalized non-supervised exercise program consisting of 3 weekly sessions of 20 min to 1-hr of moderate-to-vigorous physical activity (≥3 METs): 2 sessions of brisk walking and 1 session of muscle strengthening. Women should wear the wristband daily to track their number of steps (automatic Bluetooth synchronization to the application). Duration and intensity of sessions and target number of daily steps will progressively increase (+15% up to 10,000 steps) to place the patients in a progression dynamic. Women will receive phone-based follow-up at 1 week, 2 months, and 4 months.

BEHAVIORAL

Therapeutic education

Women will be invited to participate in the 6-month therapeutic patient education program "Mieux manger, mieux bouger" ("Eat better, move better") elaborated at the Léon Bérard cancer center. The program consists in four sessions: * a 1-hour individual session of "educational diagnosis" to assess their needs and establish a contract of objectives, * two "educational sessions" of 1h30 each using tools, in group of 10 patients maximum to improve their daily practice of physical activity, * a 1-hour individual session of "educational assessment" to evaluate whether their objectives were reached.

Sponsors & Collaborators

• Fondation ARC

  collaborator OTHER

• National Cancer Institute, France

  collaborator OTHER_GOV

• Fondation pour la Recherche Médicale

  collaborator OTHER

• Cancéropôle Lyon Auvergne Rhône-Alpes

  collaborator OTHER

• AG2R La Mondiale

  collaborator OTHER

• Centre Leon Berard

  lead OTHER

Principal Investigators

• Béatrice Fervers, MD, PhD · Centre Léon Bérard, Lyon, France

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-18

Primary Completion

2022-03-04

Completion

2022-09-23

Countries

• France

Study Locations