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COMPLETED
NCT04354233
NA

A Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer

Sponsor: Centre Leon Berard

View on ClinicalTrials.gov

Summary

INTRODUCTION: Patients with a metastatic breast cancer suffer from a deteriorated quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program based on connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer. METHODS/ANALYSIS: ABLE02 is a prospective, multicenter, randomized, controlled and, open-label study. 244 patients with a metastatic breast cancer , at least one positive hormone receptor and a first-line chemotherapy planned will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 hours a day during the whole intervention (6 months) with at least three walking sessions weekly and quizzes to answer each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application. DISCUSSION: An activity program based on smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors.

Official title: A National, Multicenter, Randomized Controlled Trial to Assess the Efficacy of a Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Women With Metastatic Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2020-06-24

Completion Date

2025-06-30

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

DEVICE

Physical activity intervention with connected devices

Participants randomized in the intervention arm will receive recommandations in physical activity. They will also receive an activity tracker Withings Steel to wear during 6 months. The tracker will be connected to the "Withings Health Mate" application and the ABLE02 application. Participants will be encouraged to practice at least three walking sessions weekly of more than 10 consecutive minutes. Concerning the number of steps per day, the first objective will be determined according to the 6-min walking distance and to participants' preferences and capacities. The objective will be recalculated monthly according to the number of steps performed the previous week and will be adapted by the physical activity (PA) instructor and participants. Phone calls with the participants are regularly planned. Weekly quizzes on PA and nutrition will be proposed through the ABLE02 application. A messaging system and a phone line will be available for participants to contact the study team.

Locations (18)

CHU Amiens

Amiens, France

Institut de Cancérologie de l'Ouest (ICO)

Angers, France

CHU Avignon

Avignon, France

CH Fleyriat

Bourg-en-Bresse, France

CH Cotentin

Cherbourg, France

CH Cholet

Cholet, France

CGFL

Dijon, France

Groupement Hospitalier Mutualiste

Grenoble, France

Centre Léon Bérard (CLB)

Lyon, France

Hospices Civils de Lyon

Lyon, France

CH Morlaix

Morlaix, France

AP-HP

Paris, France

Institut Curie

Paris, France

Institut Godinot

Reims, France

Centre Eugène Marquis

Rennes, France

Institut de Cancérologie Lucien Neuwirth (ICLN)

Saint-Etienne, France

Institut de Cancérologie de l'Ouest (ICO)

Saint-Herblain, France

Institut Gustave Roussy

Villejuif, France