A Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer (ABLE02)

Léon Bérard Center

Status: Enrolling

Conditions: Metastatic Breast Cancer

Treatments: Device: Physical activity intervention with connected devices

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04354233

ABLE02

ET20-022 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 244 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. female,
• 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

• 1. presence of unstable bone metastases or unconsolidated pathological fractures,
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

244 participants in 2 patient groups

Physical activity intervention with connected devices

Experimental group

Description:

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

Treatment:

Device: Physical activity intervention with connected devices

Standard care

No Intervention group

Description:

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