Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment: Longitudinal Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Prognostic value of presence of skin deformities, asymmetry, presence of scapular winging or other scapular or shoulder deformities
研究概览
简要总结
Breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (European Cancer Information System). The number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment.
The International Consortium for Health Outcomes Measurement Initiative described upper limb (UL) function as the health outcome that matters most for breast cancer survivors (BCS). 50% of BCS at 6 months post-radiotherapy suffer from of decreased UL function, i.e. difficulties in performing activities of daily living with the upper limb. Patients experiencing UL dysfunctions and other problems are less likely to be physically active. Given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. UL dysfunctions) is very important. Identifying these factors contributing to chronic UL dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment.
There is a need to rethink the follow-up strategy (besides the treatment of the cancer itself) and develop a clinical care pathway consisting of multifactorial screening instruments to identify women and men who are in need of extra rehabilitation efforts and specific rehabilitation goals to alleviate symptoms and side effects experienced by breast cancer survivors. This clinical care pathway should cover all aspects of the International Classification of Function, Disease and Health (ICF), a biopsychosocial framework that conceptualizes a person's level of functioning and bodily structures, activity and participation and contextual factors (including personal and environmental factors).
The present study aims to identify the factors, during and after breast cancer treatment, contributing to persistent Upper Limb (UL) dysfunctions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) for unilateral primary breast cancer or patients with oligometastatic breast cancer.
- •Patients with a cognitive and language functioning enabling coherent Dutch communication between the examiner and the participant
- •Patients who can comply with the protocol at baseline assessment and willing to provide written informed consent
排除标准
- •BCS with widespread distance metastases, previous breast surgery, or planned bilateral surgery
- •And/or with a diagnosis of a neurological or rheumatological condition,
- •And/or BCS who are not available the entire duration of the study
结局指标
主要结局
Prognostic value of presence of skin deformities, asymmetry, presence of scapular winging or other scapular or shoulder deformities
时间窗: Time frame up to 6 months post-radiotherapy
Basic inspection of skin deformities, asymmetry, presence of scapular winging or other scapular or shoulder deformities. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of pain intensity
时间窗: Time frame up to 6 months post-radiotherapy
Numeric Rating Scale (0-10) of pain intensity during movement during the week before assessment. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of impact of pain on functioning
时间窗: Time frame up to 6 months post-radiotherapy
Brief Pain Inventory: the short version assesses the the impact of the pain on functioning.The Brief Pain Inventory is a valid multimodal scale for assessing pain in breast cancer patients. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Total relative arm volume (%)
时间窗: Time frame up to 6 months post-radiotherapy
Relative arm volume: Bilateral circumferential measurements using a perimeter will be performed. Water displacement method hand: Bilateral water displacement method using a volumeter filled with water and allowed to settle at room temperature will be performed. Afterwards the total volume (mL) can be calculated by taking the sum of the two measurements. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Soft tissue stiffness index
时间窗: Time frame up to 6 months post-radiotherapy
The MyotonPRO assessment for soft-tissue stiffness and elasticity will take place at the pectoralis major, upper trapezius, infraspinatus and teres major region, from which a mean stiffness index (N/m) will be calculated. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Body-perception
时间窗: Time frame up to 6 months post-radiotherapy
A self-developed Dutch version of the Fremantle Shoulder Awareness Questionnaire will be used. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Subjective upper limb function
时间窗: Time frame up to 6 months post-radiotherapy
quickDASH (0-100) questionnaire: An abbreviated version of the original DASH (Disabilities of the Arm, Shoulder and Hand) outcome measure. The questionnaire contains 11 items that measures an individual's ability to complete tasks, absorb forces and severity of symptoms, with a 5-point Linkert scale. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Objective upper limb function
时间窗: Time frame up to 6 months post-radiotherapy
Accelerometry: duration of upper limb use (hours) during one week. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of presence of neuropathic pain
时间窗: Time frame up to 6 months post-radiotherapy
Presence of neuropathic pain (yes/no): Douleur Neuropathique en 4 questions (DN4) is a questionnaire generated for identifying pain of predominantly neuropathic origin. The DN4 consists of 7 self-reporting questions and 3 clinical examinations. A scoring of ≥4/10 is considered as a positive result for neuropathic pain. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of presence of widespread pain
时间窗: Time frame up to 6 months post-radiotherapy
Presence of widespread pain (yes/no) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Self-efficacy
时间窗: Time frame up to 6 months post-radiotherapy
General Self-Efficacy Scale:This scale is a self-report measure of self-efficacy with 10 items (scored from 1-4). The total score is calculated by finding the sum of the all items. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of presence of sensory loss
时间窗: Time frame up to 6 months post-radiotherapy
Presence of sensory loss (yes/no) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of movement functions during a functional task
时间窗: Time frame up to 6 months post-radiotherapy
The 3D scapulothoracic and glenohumeral movements will be assessed using inertial sensors (MTw motion capture, Xsens Technologies, The Netherlands) at the endpoint (i.e. point of task achievement) of the performance of a functional task, the Upper Limb Function Test (ULIFT), which is a valid and reliable test to assess upper limb functionality in breast cancer patients. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Depression, Anxiety and Stress
时间窗: Time frame up to 6 months post-radiotherapy
Depression, Anxiety and Stress Scale (DASS-21) (range 0-132). The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of soft tissue adhesions
时间窗: Time frame up to 6 months post-radiotherapy
The 'Myofascial Adhesions in Patients after Breast Cancer (MAP-BC)'-tool will be used to assess the severity of soft tissue adhesions at the upper limb region (0-63) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Upper limb muscle strength (kg)
时间窗: Time frame up to 6 months post-radiotherapy
A hand-held dynamometer will be used to assess handgrip strength Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Pain catastrophizing
时间窗: Time frame up to 6 months post-radiotherapy
Pain Catastrophizing Scale (0-52) : It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Fear of movement
时间窗: Time frame up to 6 months post-radiotherapy
Adjusted 11-item Tampa Scale of Kinesiophobia. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Thus, total scores range from 11-44 points with higher scores indicating greater fear of pain, movement, and injury Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of treatment with Chemotherapy
时间窗: Time frame up to 6 months post-radiotherapy
no/taxanes/non-taxanes and neo-adjuvant/adjuvant (derived from the medical file) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Quality of Life
时间窗: Time frame up to 6 months post-radiotherapy
European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30). The QLQ-C30 is a validated questionnaire that incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of (Sub)optimal physical therapy care
时间窗: Time frame up to 6 months post-radiotherapy
Through a self-developed questionnaire, patients will be questioned whether they received no/suboptimal/optimal physical therapy care Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of treatment with Hormone therapy
时间窗: Time frame up to 6 months post-radiotherapy
no/aromatase inhibitor/no-aromatase inhibitor (derived from the medical file) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
次要结局
未报告次要终点