sCANsens: Identifying Biomarkers for Chronic Pain After Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Severity of pain symptoms
研究概览
简要总结
Up to 40% of women experience chronic pain after treatment for breast cancer, and this pain is often very disabling. However, chronic pain after breast cancer remains under-recognised and undertreated. An effective and patient-tailored approach of (chronic) pain after breast cancer indeed requires a thorough knowledge and
evaluation of the pain. In daily clinical practice, however, guidelines for a comprehensive diagnosis of pain in cancer patients and survivors are lacking. Further research in this topic is crucial for an efficient, preventive as well as curative, approach of pain after breast cancer. Besides the high prevalence and the important impact of pain in this population, the breast cancer population is also an ideal population to study chronic pain and its natural time course in different stages, since most patients start pain-free, but almost half of them end up
with chronic pain. Therefore, this study aims to map biomarkers (both predictive, prognostic and diagnostic) for chronic pain after breast cancer treatment. We will study possible biopsychosocial biomarkers in
relation to (chronic) pain and monitor their temporal changes from the moment of diagnosis until 1 year after surgery. The potential biomarkers are situated within the medical imaging of the brain, measurements of pain sensitivity and psychological variables.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unilateral breast cancer
- •Pain at enrollment <3/10 on average during the past week
- •First cancer diagnosis
排除标准
- •Pre-existing pain conditions
- •major pre-existing neurological disorders
- •No recurrent cancer or metastasis
- •No previous surgery in area
结局指标
主要结局
Severity of pain symptoms
时间窗: Time frame up to 1 year post-surgery
Adjective list of pain symptoms included in the Mc Gill Pain Questionnaire Dutch : Language Version (0-63): Self-report of pain evaluating the sensory intensity, emotional impact and the cognitive evaluation of pain. Each part or dimension of the MPQ is individually scored and a cumulative total score is also recorded. Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
Pain intensity
时间窗: Time frame up to 1 year post-surgery
Visual Analogue Scale included in the Mc Gill Pain Questionnaire is a 100mm horizontal line were the patient is asked to indicate his/her perceived pain intensity at this moment, the minimum and the maximum of the pain. Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
Influence of pain on the quality of life
时间窗: Time frame up to 1 year post-surgery
Quality of Life questions included in the Mc Gill Pain Questionnaire: self-report to indicate the impact of pain on quality of life. The higher the score the higher the impact (0-27). Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
Localisation of pain
时间窗: Time frame up to 1 year post-surgery
Localisation and experience of pain after cancer treatment measured with the Mc Gill Pain Questionnaire Dutch Language Version: Anamnesis questions to localize the pain and the experience of the patient. Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery
次要结局
- Prognostic value of temporal summation(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of Resilience(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of Pain Catastrophizing(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of Positive and Negative affect(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of Depression, Anxiety and Stress(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of conditioned pain modulation(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of hyperalgesia(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of gray matter differences(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of Fractional Anisotropy(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of single nucleotide polymorphisms (SNPs)(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of functional connectivity(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of cytokine expression(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of Brain Derived Neurotrophic factor expression(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
- Prognostic value of the percentage CpG methylation in gene regions of selected cytokine and Brain Derived Neurotrophic Factor genes.(Assessment at T0: pre-surgery, T1: 1-3 weeks post-surgery, T2: 3 months post-surgery, T3: 1 year post-surgery)
研究者
Prof. dr. Mira Meeús
Prof. Dr.
Universiteit Antwerpen