NCT03529383已完成不适用
Randomized Controlled Trial Evaluating the Efficacy of an Adapted Physical Activity Program Using a Connected Device With Activity Trackers and a Therapeutic Education Program Among Women With Localized Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 436
- 试验地点
- 4
- 主要终点
- Number of patients achieving the internationally recommended level of physical activity of at least 150 minutes per week of moderate-to-vigorous physical activity (intensity ≥3 METs)
研究概览
简要总结
The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.
详细描述
Rationale:
In women with breast cancer, weight gain, obesity, and lack of physical activity have been shown to increase the risk of comorbidities and deleterious long-term outcomes. Despite the safety of physical activity and the benefits of physical activity performed concomitant to treatment on fatigue, quality of life, and possibly survival, its implementation is not systematic in the cancer care pathway.
Methods:
The DISCO study is a randomized, controlled, multicenter intervention study that will be conducted among 432 women treated for localized breast cancer. Patients will be randomly assigned to one of the four arms of the study according to a 1:1:1:1 ratio.
- Women allocated to the "connected device" arm will benefit from a 6-month personalized exercise program consisting of three weekly sessions of aerobic and strength exercises, carried out autonomously with a connected device (wristband, smartphone application, website).
- Women allocated to the "therapeutic education" arm will follow a 6-month program of therapeutic patient education.
- Women allocated to the "combined" arm will benefit from both interventions in parallel.
- Women allocated to the "control" arm will receive standard care, i.e., international recommendations on physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between 18 and 75 years old,
- •Being diagnosed with a first primary non-metastatic invasive breast carcinoma, that has been histologically confirmed,
- •Having been operated and requiring the prescription of an adjuvant treatment (chemotherapy, hormonotherapy, radiotherapy),
- •Whose adjuvant treatment will be prescribed (for hormone therapy) or carried out (for chemotherapy and radiotherapy) in one of the investigating centers,
- •Being able to practice adapted physical activity and providing a medical certificate of no contraindications to exercise issued by the investigator physician, the general practitioner, or the referring physician,
- •Available and willing to participate in the study for the duration of the interventions and follow-up,
- •Using a personal smartphone compatible with the application (iOS operating system from version 9.3, Android operating system from version 5.0, no Microsoft operating system) and having Internet access on a computer,
- •Able to understand, read, and write French,
- •Affiliated with a social security scheme,
- •Having dated and signed an informed consent.
排除标准
- •Woman with recurrent, metastatic, or inflammatory breast cancer,
- •Personal history or co-existence of another 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),
- •Presenting a contraindication to exercise according to the investigator (such as cardiorespiratory or bone pathologies, non-stabilized chronic diseases such as diabetes, malnutrition, etc.),
- •In a state of severe malnutrition according to the criteria of the French National Health Authority (i.e., in women ≤ 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month; in women > 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month, and body mass index < 18 kg/m²),
- •Unable to be followed for medical, social, family, geographic or psychological reasons for the duration of the study,
- •Participating in simultaneous physical activity studies,
- •Deprived of their liberty by court or administrative decision,
- •Pregnant or breastfeeding or of childbearing age without effective contraception for the duration of the study.
结局指标
主要结局
Number of patients achieving the internationally recommended level of physical activity of at least 150 minutes per week of moderate-to-vigorous physical activity (intensity ≥3 METs)
时间窗: 6 months
Assessed by the RPAQ self-administered questionnaire
次要结局
- Proportion of patients who change their physical condition (Hand-grip test)(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their physical condition (sit-and-reach flexibility test)(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their waist circumference(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their BMI(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients with a modification on plasma circulating levels of cytokines (inflammatory cytokines: IL-6, TNF, and CRP; adipokines: adiponectin and leptin)(Change between Day 0 and 6 months)
- Number of patients who accept the therapeutic program(Baseline, 6 months and 12 months)
- Proportion of patients who change their physical activity profile (Time spent in different intensities of physical activity, time spent in sedentary activities)(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their lean body mass in body composition(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their tobacco use(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their alcohol intake(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients with a change in health-related quality of life(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients with a modification on serum circulating levels of endocrine factors (insulin, IGF1, estradiol)(Change between Day 0 and 6 months)
- Proportion of patients who refuse to participate(Baseline (day 0))
- Number of patients achieving the internationally recommended level of physical activity of at least 150 minutes per week of moderate-to-vigorous physical activity (intensity ≥3 METs)(12 months)
- Proportion of patients who are compliant to the programs(6 months)
- Proportion of patients who change their physical condition (6-min walking test)(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their physical condition (Sit to stand test)(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their fat mass in body composition(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their fat free mass in body composition(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients with a modification on vitamin D status(Change between Day 0 and 6 months)
- Proportion of patients who change their physical condition(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their weight(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their hip circumference(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who change their water in body composition(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients with a change in quality of life(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients with a change in fatigue condition(Change between baseline and 6 months and between 6 months and 12 months)
- Proportion of patients who modify their professional status(Change between baseline and 6 months and between 6 months and 12 months)
- Number of patients who accept the connected device(Baseline, 6 months and 12 months)
研究者
研究点 (4)
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