A Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer
NCT ID: NCT04354233
Last Updated: 2024-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
244 participants
INTERVENTIONAL
2020-06-24
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Physical activity intervention with connected devices
Women randomized to the intervention arm will follow a 6-month physical activity intervention using a connected device that includes an activity tracker, a smartphone and a mobile application. Patients will also receive physical activity international recommendations
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.
Standard care
Women will receive stardard care and physical activity international recommendations, without further intervention
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 2\) ≥ 18 years old,
* 3\) histologically confirmed metastatic breast cancer, with at least one positive hormone receptor (HR+) and HER2-,
* 4\) first-line chemotherapy planned (or until 1 month after the chemotherapy has started) with intravenous (Paclitaxel or Doxorubicin or Cyclophosphamide or Carboplatin) or per os (Capecitabine or Vinorelbine) administration - NB : a patient who has previously received one or more lines of hormone therapy and who must start a 1st line of chemotherapy is eligible,
* 5\) Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2,
* 6\) life expectancy ≥ 3 months,
* 7\) willing to be involved throughout the study,
* 8\) ability to practice a adapted physical activity (APA) certified by a medical certificate issued by the referring oncologist or the clinical investigator,
* 9\) using a compatible smartphone or Tablet PC to download the application ABLE02 and Withings Health Mate (from iOS 10 and android 6.0 and more recent),
* 10\) Internet access,
* 11\) valid health insurance affiliation,
* 12\) able to read, write and understand French.
Exclusion Criteria
* 2\) presence of central nervous system involvement with neurological deficits that prevent from walking,
* 3\) presence of a history or co-existence of other primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years),
* 4\) 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 weight loss of ≥ 15% in 6 months or ≥10% in 1 month, and body mass index \<18 kg/m²),
* 5\) presenting a PA contraindication (e.g., uncontrolled hypertension, uncontrolled heart disease),
* 6\) concurrent participation in another PA study,
* 7\) unable to be followed for medical, social, family, geographical or psychological reasons throughout the study,
* 8\) deprived of liberty by judicial or administrative decision,
* 9\) pregnant.
18 Years
FEMALE
No
Sponsors
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Fondation ARC
OTHER
Janssen, LP
INDUSTRY
Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Olivier TREDAN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Philippe DEBOURDEAU
Role: primary
Hubert ORFEUVRE
Role: primary
Margot NOBLECOURT
Role: primary
Elise BONNET
Role: primary
Florence COUSSY
Role: primary
Christelle JOUANNAUD
Role: primary
References
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Delrieu L, Anota A, Tredan O, Freyssenet D, Maire A, Canada B, Fournier B, Febvey-Combes O, Pilleul F, Bouhamama A, Caux C, Joly F, Fervers B, Pialoux V, Perol D, Perol O. Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial. BMC Cancer. 2020 Jul 3;20(1):622. doi: 10.1186/s12885-020-07093-9.
Other Identifiers
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ET20-022
Identifier Type: OTHER
Identifier Source: secondary_id
ABLE02
Identifier Type: -
Identifier Source: org_study_id
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