Effects of Structured and Individualized Exercise in Patients With Metastatic Breast Cancer on Fatigue and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UMC Utrecht
- 入组人数
- 357
- 试验地点
- 1
- 主要终点
- Cancer-related physical fatigue
研究概览
简要总结
Currently, the effect of exercise on metastatic breast cancer has not been extensively studied, even though the benefits are evident in the curative setting. The investigators designed the EFFECT study to assess the effects of a 9-month structured and individualised exercise intervention in 350 patients with metastatic breast cancer (stage IV) on cancer-related physical fatigue, Health-Related Quality of Life (HRQoL), and other disease and treatment-related side effects at six months (primary endpoint).
详细描述
The EFFECT study is a multicentre, randomised controlled trial. The intervention group will participate in a 9-month exercise intervention. The exercise program will start with a 6-month period, where patients participate in a supervised multimodal exercise program twice a week supplemented with unsupervised exercises. The multimodal exercise program comprises aerobic-, resistance- and balance components. After completing the initial six-month period, one supervised session will be replaced by one unsupervised session until month nine.
Unsupervised exercises will be supported by an activity tracker (FitBit) and an exercise App specifically designed for the EFFECT trial. Patients randomized to the control group will also receive an activity tracker (like the intervention group). The investigators will advice control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150min/week in line with the current exercise guidelines.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of breast cancer stage IV
- •ECOG (Eastern Cooperative Oncology Group scale) performance status ≤ 2
- •Able and willing to perform the exercise program and wear the activity tracker
排除标准
- •A potential subject who meets any of the following criteria is not eligible for enrolment into this study:
- •Unstable bone metastases inducing skeletal fragility as determined by the treating clinician
- •Untreated symptomatic known brain metastasis
- •Estimated life expectancy < 6 months as determined by the treating clinician
- •Serious active infection
- •Too physically active (i.e. >210 minutes/week of moderate-to-vigorous intentional exercise
- •Severe neurologic or cardiac impairment according ACSM criteria
- •Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise
- •Uncontrolled severe pain
- •Any other contraindications for exercise as determined by the treating physician
- •Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician
- •Pregnancy
研究组 & 干预措施
Control group
Patients randomized to the control group will also receive an activity tracker (like the intervention group). We will advice control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150min/week in line with the current exercise guidelines.
Supervised exercise group
The intervention group will participate in a 9-month exercise intervention. The exercise program will start with a 6-month period, where patients participate in a supervised multimodal exercise program twice a week supplemented with unsupervised exercises. The multimodal exercise program comprises aerobic-, resistance- and balance components. After completing the initial six-month period, one supervised session will be replaced by one unsupervised session until month nine.
Unsupervised exercises will be supported by an activity tracker (FitBit) and an exercise App specifically designed for the EFFECT trial
干预措施: Supervised exercise (Behavioral)
结局指标
主要结局
Cancer-related physical fatigue
时间窗: 0- 6 months (measured at baseline, 3 and 6 months)
Physical fatigue measured with the EORTC QLQ-FA12
Health-related Quality of Life
时间窗: 0- 6 months (measured at baseline, 3 and 6 months)
Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score
次要结局
- Physical performance(0-6 months)
- Physical fitness(0-6 months)
- Intervention costs(0-9 months)
- Satisfaction with exercise intervention(0-9 months)
- Pain: severity and its impact on functioning.(0-9 months)
- Treatment-related toxicities grade≥3(0-9 months)
- Weight(0-6 months)
- Height(0-6 months)
- Waist circumference(0-6 months)
- Neuropathic pain(0-9 months)
- Pain Catastrophizing(0-9 months)
- Sleep(0-9 months)
- Separate HRQoL domains and Summary Score(0-9 months)
- Cancer-related fatigue(0-9 months)
- Breast cancer specific symptoms(0-9 months)
- Anxiety, depression(0-9 months)
- Physical activity (objective)(0-6-9 months)
- Body composition (fat free mass and fat mass)(0-6 months)
- Physical activity (subjective)(0-6-9 months)
- Resting heart rate(0-6 months)
- Blood pressure(0-6 months)
- Work status/ healthcare resources consumption(0-9 months)
- Cancer treatment(0-9 months)
- Quality of working life(0-9 months)
- Health status(0-9 months)
- Disease control(0-9 months)
- Biomarkers (systemic inflammation, growth factors, blood/brain barrier modulators)(0-6 months)