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

NCT04354233 | Completed

• 2 other identifiers: ABLE02ET20-022
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancer; Physical activity; Connected devices; e-Health; Quality of life; Fatigue

Outcome Measures

Primary Outcomes (2)

• time to deterioration of global health status (GHS) score of EORTC QLQ C30

  Health-Related Quality of Life (HRQoL) and fatigue will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). QLQ-C30 questionnaire consists of 30 items to evaluate 5 functioning domains (physical, role, emotional, cognitive, and social), a global HRQoL domain, 3 symptom domains (pain, fatigue and nausea) and 6 single items (dyspnea, insomnia, anorexia, diarrhea, constipation and financial impact). Participants will answer to a Likert scale ranging from "not at all" to "very much" and from "very bad" to "excellent" only for the global HRQoL questions. All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden. Deterioration is defined as a 5-point decrease relative to baseline in GHS score, with no subsequent increase above this threshold.

  Month 18

• time to deterioration of fatigue score of EORTC QLQ C30

  Health-Related Quality of Life (HRQoL) and fatigue will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). QLQ-C30 questionnaire consists of 30 items to evaluate 5 functioning domains (physical, role, emotional, cognitive, and social), a global HRQoL domain, 3 symptom domains (pain, fatigue and nausea) and 6 single items (dyspnea, insomnia, anorexia, diarrhea, constipation and financial impact). Participants will answer to a Likert scale ranging from "not at all" to "very much" and from "very bad" to "excellent" only for the global HRQoL questions. All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden. A deterioration of fatigue is defined as a 5-point increase relative to baseline fatigue score, with no subsequent decrease above this threshold.

  Month 18

Secondary Outcomes (22)

• Overall survival

  Month 18

• Progression free survival

  Month 18

• Other dimensions of health-related quality of life of the EORTC QLQ C30

  Baseline, Month 3, Month 6, Month 12

• Fatigue

  Baseline, Month 3, Month 6, Month 12

• Proportion of patients who change their physical condition (6-min walking distance)

  Change between baseline, Month 3, Month 6 and Month 12

Study Arms (2)

Physical activity intervention with connected devices

EXPERIMENTAL

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

Device: Physical activity intervention with connected devices

Standard care

NO INTERVENTION

Women will receive stardard care and physical activity international recommendations, without further intervention

Interventions

Physical activity intervention with connected devices DEVICE

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.

Physical activity intervention with connected devices

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) female,
• \) ≥ 18 years old,
• \) histologically confirmed metastatic breast cancer, with at least one positive hormone receptor (HR+) and HER2-,
• \) 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,
• \) Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2,
• \) life expectancy ≥ 3 months,
• \) willing to be involved throughout the study,
• \) ability to practice a adapted physical activity (APA) certified by a medical certificate issued by the referring oncologist or the clinical investigator,
• \) 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),
• \) Internet access,
• \) valid health insurance affiliation,
• \) able to read, write and understand French.

You may not qualify if:

• \) presence of unstable bone metastases or unconsolidated pathological fractures,
• \) presence of central nervous system involvement with neurological deficits that prevent from walking,
• \) 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),
• \) 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),
• \) presenting a PA contraindication (e.g., uncontrolled hypertension, uncontrolled heart disease),
• \) concurrent participation in another PA study,
• \) unable to be followed for medical, social, family, geographical or psychological reasons throughout the study,
• \) deprived of liberty by judicial or administrative decision,
• \) pregnant.

Sponsors & Collaborators

• Centre Leon Berard: lead
• Fondation ARC: collaborator
• Janssen, LP: collaborator

Study Sites (18)

CHU Amiens

Amiens, France

Location

Institut de Cancérologie de l'Ouest (ICO)

Angers, France

Location

CHU Avignon

Avignon, France

Location

CH Fleyriat

Bourg-en-Bresse, France

Location

CH Cotentin

Cherbourg, France

Location

CH Cholet

Cholet, France

Location

CGFL

Dijon, France

Location

Groupement Hospitalier Mutualiste

Grenoble, France

Location

Centre Léon Bérard (CLB)

Lyon, 69008, France

Location

Hospices Civils de Lyon

Lyon, France

Location

CH Morlaix

Morlaix, France

Location

AP-HP

Paris, France

Location

Institut Curie

Paris, France

Location

Institut Godinot

Reims, France

Location

Centre Eugène Marquis

Rennes, France

Location

Institut de Cancérologie Lucien Neuwirth (ICLN)

Saint-Etienne, France

Location

Institut de Cancérologie de l'Ouest (ICO)

Saint-Herblain, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Related Publications (1)

• 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.

  PMID: 32620149 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier TREDAN, MD, PhD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At the first visit of the study, participants will be randomly assigned (1:1 ratio), with minimization based on the presence of visceral metastases (presence vs. absence of visceral metastases), the method of administration of chemotherapy (intravenous vs. per os) and the 6-minute walking distance (6MWD) (\<455 versus ≥ 455m based on the median of the pilot ABLE study) to: (i) the intervention arm to receive PA recommendations and benefit from a 6-month APA program (ii) the control arm to receive PA recommendations only.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 21, 2020
• Study Start: June 24, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (18)