Randomized Study Estimating the Impact of a Personalized and Remote Support Centered on Exercise and Physical Activity for Patients After Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 824
- 试验地点
- 32
- 主要终点
- Quality of Life (QoL): SF 36 MCS
研究概览
简要总结
A study that evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.
详细描述
A multicentric, phase III, randomized open-labelled study with two parallel groups which evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.
Other objectives include:
- To evaluate the impact of the intervention on each dimension of the SF-36 at 12 months
- To evaluate the impact of the program on the health-related quality of life over time
- To evaluate the impact of the program on the practice of exercise and physical activity (EPA) at the recommended intensity (30min of moderate EPA, 5 days/week)
- To evaluate the impact of the program on:
o fatigue, pain, depression, sleep, motivation for the practice, self-respect, biometric measures (including fat mass and lean mass), physical capacities, patient's satisfaction regarding the assigned program, occurrence of Adverse Events (AE) related to the treatment, professional life for patients who worked before the announcement of getting cancer and psychotropic and analgesic drug intake
- To evaluate the compliance to the program through the engagement score during the first 4 months (in the experimental group).
- To evaluate the impact of the program in terms of disease-free survival
Additional objectives on health economics include:
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
- •Patient ≥18;
- •Diagnosis of invasive non-metastatic breast cancer;
- •5 months (+/- 3 months) after the end of the treatment by surgery and/or radiotherapy and/or chemotherapy and/or other "short-term" systemic treatment : immunotherapy, PARP inhibitor, trastuzumab or TDM1 ; the continuation of hormonotherapy (more or less associated with an anti-CDK4/6), trastuzumab or TDM1 is possible during the study period;
- •SF-36 filled in completely
- •Medical certificate for sports practice delivered by a healthcare professional or oncologist. Neither the previous sports practice, nor the motivation for the proposed program is necessary to participate in the program.
- •Agreement for follow-ups during the study period lasting 12 months;
- •Ability to understand, read and write French;
- •Patient covered by the French "Social Security" regime;
- •Signed informed consent for the participation in the study, including the randomization with a 50%/50% chance of being allocated to one or the other group.
排除标准
- •Relapse of invasive breast cancer (loco-regional relapse, contralateral relapse)
- •Inability to exercise because of a severe handicap or vulnerability. These contraindications are left to the discretion of the healthcare professional assessing capacity (ex : severe malnutrition, pregnancy …);
- •Metastatic cancer;
- •Expressed preference for one arm;
- •Inability to comply with follow-up (4 and 12 months) of the trial (geographical, social, medical or psychological reasons);
- •Person under guardianship or curatorship.
研究组 & 干预措施
Arm A: personalized coaching for physical activities
This arm consists of providing patients with a personalized coaching focused on exercise and physical activity, with or without connected watch.
干预措施: Personalized Coaching (Arm A) (Other)
Arm B: standard supportive approach
The standard supportive approach will consist in recommendations made during visits with the oncologist. The delivery of post-treatment care by oncologists and their team systematically provide exercise advice patients including recommendations for strength training and aerobic activity.
干预措施: Standard supportive approach (Arm B) (Other)
结局指标
主要结局
Quality of Life (QoL): SF 36 MCS
时间窗: 1 year from the inclusion
This study will evaluate, in each randomized group, the difference between the baseline score and the 12-month score of summary score of this questionnaire: MCS (Mental Component Summary)
Quality of Life (QoL): SF 36 PCS
时间窗: 1 year from the inclusion
This study will evaluate, in each randomized group, the difference between the baseline score and the 12-month score of summary score of this questionnaire: PCS (Physical Component Summary)
次要结局
- Success/Failure score(at 12 months after start of the program)
- Depression(at the baseline, and 12 months.)
- Biometric measures (impedance)(at the baseline, 4 months, 8 months and 12 months.)
- Professional activity status(at the baseline, 4 months, 8 months and 12 months.)
- Drug intake(at the baseline, 4 months, 8 months and 12 months.)
- Disease-free survival(at the baseline, 4 months, 8 months and 12 months.)
- Fatigue(at the baseline, and 12 months.)
- Health Related Quality of Life (HRQoL)(at the baseline, 4 months, 8 months and 12 months.)
- Practice of Exercise and Physical Activities (EPA)(at the baseline, 4 months, 8 months and 12 months.)
- Pain level(at the baseline, and 12 months.)
- Sleep(at the baseline, and 12 months.)
- Health states descriptive system(at the baseline, 4 months, 8 months and 12 months.)
- Physical capacities(at the baseline, 4 months, 8 months and 12 months.)
- Adverse Events(at the baseline, 4 months, 8 months and 12 months.)