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

Last updated: August 20, 2024
Sponsor: Centre Leon Berard
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Metastatic Cancer

Pain (Pediatric)

Treatment

Physical activity intervention with connected devices

Clinical Study ID

NCT04354233
ABLE02
ET20-022
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. female,
  1. ≥ 18 years old,
  1. histologically confirmed metastatic breast cancer, with at least one positivehormone receptor (HR+) and HER2-,
  1. first-line chemotherapy planned (or until 1 month after the chemotherapy hasstarted) with intravenous (Paclitaxel or Doxorubicin or Cyclophosphamide orCarboplatin) or per os (Capecitabine or Vinorelbine) administration - NB : apatient who has previously received one or more lines of hormone therapy andwho must start a 1st line of chemotherapy is eligible,
  1. Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2,
  1. life expectancy ≥ 3 months,
  1. willing to be involved throughout the study,
  1. ability to practice a adapted physical activity (APA) certified by a medicalcertificate issued by the referring oncologist or the clinical investigator,
  1. using a compatible smartphone or Tablet PC to download the application ABLE02and Withings Health Mate (from iOS 10 and android 6.0 and more recent),
  1. Internet access,
  1. valid health insurance affiliation,
  1. able to read, write and understand French.

Exclusion

Exclusion Criteria:

  1. presence of unstable bone metastases or unconsolidated pathological fractures,
  1. presence of central nervous system involvement with neurological deficits thatprevent from walking,
  1. presence of a history or co-existence of other primary cancer (except of insitu cancer regardless of the site and/or basal cell skin cancer and/ornon-mammary cancer in complete remission for more than 5 years),
  1. severe undernutrition (HAS) (i.e. for women ≤ 70 years old: a weight loss of ≥ 15% in 6 months or ≥10% in 1 month and for women over 70 years old: a weightloss of ≥ 15% in 6 months or ≥10% in 1 month, and body mass index <18 kg/m²),
  1. presenting a PA contraindication (e.g., uncontrolled hypertension, uncontrolledheart disease),
  1. concurrent participation in another PA study,
  1. unable to be followed for medical, social, family, geographical orpsychological reasons throughout the study,
  1. deprived of liberty by judicial or administrative decision,
  1. pregnant.

Study Design

Total Participants: 244
Treatment Group(s): 1
Primary Treatment: Physical activity intervention with connected devices
Phase:
Study Start date:
June 24, 2020
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • CHU Amiens

    Amiens,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest (ICO)

    Angers,
    France

    Site Not Available

  • CHU Avignon

    Avignon,
    France

    Active - Recruiting

  • CHRU Besançon

    Besançon,
    France

    Site Not Available

  • CH Fleyriat

    Bourg-en-Bresse,
    France

    Active - Recruiting

  • CH Cotentin

    Cherbourg,
    France

    Site Not Available

  • CH Cholet

    Cholet,
    France

    Active - Recruiting

  • CGFL

    Dijon,
    France

    Site Not Available

  • Groupement Hospitalier Mutualiste

    Grenoble,
    France

    Active - Recruiting

  • Centre Léon Bérard (CLB)

    Lyon, 69008
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Lyon,
    France

    Site Not Available

  • CH Morlaix

    Morlaix,
    France

    Terminated

  • AP-HP

    Paris,
    France

    Site Not Available

  • Institut Curie

    Paris,
    France

    Active - Recruiting

  • Institut Godinot

    Reims,
    France

    Active - Recruiting

  • Centre Eugène Marquis

    Rennes,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest (ICO)

    Saint-Herblain,
    France

    Site Not Available

  • Institut de Cancérologie Lucien Neuwirth (ICLN)

    Saint-Étienne,
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif,
    France

    Site Not Available

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