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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 35
- 主要终点
- time to deterioration of global health status (GHS) score of EORTC QLQ C30
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Physical activity intervention with connected devices (Device)
Standard care
Women will receive stardard care and physical activity international recommendations, without further intervention
结局指标
主要结局
time to deterioration of global health status (GHS) score of EORTC QLQ C30
时间窗: Month 18
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.
time to deterioration of fatigue score of EORTC QLQ C30
时间窗: Month 18
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.
次要结局
- 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)
- Proportion of patients who change their physical condition (handgrip strength)(Change between baseline, Month 3, Month 6 and Month 12)
- Proportion of patients who change their waist circumference(Change between baseline, Month 3, Month 6 and Month 12)
- Proportion of patients who change their physical condition (sit-to-stand)(Change between baseline, Month 3, Month 6 and Month 12)
- Proportion of patients who change their hip circumference(Change between baseline, Month 3, Month 6 and Month 12)
- Proportion of patients who have modifications on oxidative stress according to blood sample analysis(Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18)
- Proportion of patients who change their weight(Change between baseline, Month 3, Month 6 and Month 12)
- Proportion of patients who change their physical activity level(Change between baseline, Month 3, Month 6 and Month 12)
- Proportion of patients who change sleep disorders(Change between baseline and Month 6)
- Proportion of patients who loss muscle mass (sarcopenia)(Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18)
- Proportion of patients who change their dietary patterns(Change between baseline and Month 6)
- Proportion of patients who have severe toxicity (grade > 2)(Month 12)
- Proportion of patients who are compliant to the PA intervention (in the intervention arm only)(Month 6)
- Proportion of patients who have modifications in inflammation and sarcopenia according to blood sample analysis(Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18)
- Proportion of patients who modify their personnality factors(Change between baseline and Month 6)
- Proportion of patients who modify their behaviour in association with physical activity(Change between baseline and Month 6)
- Proportion of patients who accept the connected device (in the intervention arm only)(Month 6)
- Proportion of patients who modify their cognition(Change between baseline, Month 6 and Month 12)