BIOpsychosocial Approach of the CAncer-RElated FAtigue
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Physical characteristics 1
研究概览
简要总结
One of the most common and stressful side effects of the disease and associated treatments is cancer-related fatigue. It deeply disrupts quality of life and can have a negative impact on patient survival. However, cancer-related fatigue is largely underestimated by patients and poorly taken into account by clinicians. One of the reasons for its poor management is a lack of knowledge of the underlying mechanisms and risk factors.
Although a multiplicity of factors are associated with the appearance of cancer-related fatigue, we do not know their respective share, nor the nature of their interactions. The phenomenon studied reveals complex and systemic interactions between the biological, psychological and social dimensions. Recent systematic reviews clearly identify 2 locks currently preventing a better understanding of the mechanisms of cancer-related fatigue: i) lack of longitudinal studies, ii) lack of interdisciplinary studies. It is precisely these two challenges that the BIOCARE FActory project wishes to respond to.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient followed at the Victor Hugo Clinic, Le Mans.
- •Patients aged >or= 18 and < 80 years old at the time of inclusion
- •Patients with a histologically proven primary breast cancer from stage I to IIIc
- •Naive patient of anti-cancer treatment for this cancer
- •Agreement to participate in the study by written, informed and signed consent of the patient
- •Affiliated patients or beneficiaries of a social security scheme
- •ECOG Performance Status score ≤ 2
排除标准
- •Comorbidity which can explain the symptoms of fatigue (Long-term illness other than cancer, chronic fatigue syndrome)
- •Breathing difficulties requiring the use of respiratory assistance
- •Signs of polyneuropathy, amyotrophy or myasthenic syndrome
- •Contraindications to physical exercise linked to heart failure.
- •Treatment based on psychostimulants, psychotropics, antidepressants, antiepileptics or benzodiazepines for more than 3 months at the time of the study
- •Presence or history of psychosis, bipolarity or severe depression
- •History of stroke
- •History of chronic fatigue
- •History of musculoskeletal disorders of the lower limbs
- •Pregnancy, breastfeeding
- •Patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons
结局指标
主要结局
Physical characteristics 1
时间窗: 18 months
Change from baseline of height (in meters)
Physical characteristics 2
时间窗: 18 months
Change from baseline of mass (in kilograms)
Physical characteristics 4
时间窗: 18 months
Change from baseline of leg volum
Cognitive function 2
时间窗: 18 months
Change from baseline of Montreal Cognitive Assessment score (higher score means better outcome)
Fatigability
时间窗: 18 months
Change from baseline at critical force test measurement
Functional cardio-respiratory capability
时间窗: 18 months
Change from baseline of the maximum volum of oxygen during Astrand-Rhyming test
Sarcopenia 1
时间窗: 18 months
Change from baseline of body masse index
Quality of life status
时间窗: 18 months
Change from baseline of the European Organisation for Research and Treatment of Cancer quality of life C30 questionnaire score (higher score means better outcome)
Sociability status
时间窗: 18 months
Change from baseline of a Comprehensive interview
Fatigue
时间窗: 18 months
Change from baseline of the European Organisation for Research and Treatment of Cancer Fatigue questionnaire score (higher score means worse outcome)
Postural stability
时间窗: 18 months
Change from baseline of maximum displacement speed of pressure centre at the postural stability test
Physical characteristics 3
时间窗: 18 months
Change from baseline of fat mass (in percentage)
Cognitive function 3
时间窗: 18 months
Change from baseline of Trail Making test score (higher score means worse outcome)
Sarcopenia 2
时间窗: 18 months
Change from baseline of musculo-skeletal index measurement on the third lumbar vertebra on scanner
Cognitive function 1
时间窗: 18 months
Change from baseline of Stroop test score (higher score means worse outcome)
Anxiety
时间窗: 18 months
Change from baseline of the Hospital Anxiety and Depression scale score (higher score means worse outcome)
Emotional function
时间窗: 18 months
Change from baseline of the Brief Cope test score
Level of activity
时间窗: 18 months
Change from baseline of actimetry mesurement
Inflammatory status (pro-inflammatory cytokines)
时间窗: 18 months
Change from baseline of blood inflammatory markers determined by ELISA test (pro-inflammatory cytokines : IL-6, TNFα, IL-8, IL-1β)
Inflammatory status (anti inflammatory cytokine)
时间窗: 18 months
Change from baseline of blood inflammatory markers determined by ELISA test ( anti inflammatory cytokine : IL-1ra)
次要结局
未报告次要终点