Body Image, Health-related Quality of Life, and Function After Soft Tissue Sarcoma Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Range of motion in degrees
研究概览
简要总结
The goal of this study is to assess body image, health-related quality of life (QoL), and functioning (gait function, joint function, and walking ability) in patients after resection of localized soft tissue sarcoma (STS) of the extremities. A secondary objective is to assess the influence of different variables (e.g., radiotherapy, ethnicity, etc.) on body image, health-related QoL, and functioning.
Patients who underwent a surgical resection at the Amsterdam UMC between 2010 and 2021 will be approached to participate in the study. Participants will complete four questionnaires and undergo a physical examination. Additionally, they will have a 3D gait analysis, a 6-minute walk test with gas analysis, and a muscle strength assessment. Furthermore, muscle volume change will be evaluated on pre- versus postoperative MRI scans.
详细描述
Primary objectives :
- To assess body image, health-related QoL, self-reported activity limitations, and pain after STS resections as defined in the The International Classification of Functioning, Disability and Health (ICF) domains.
- To assess the functioning of the patients after STS resections as defined by the ICF domains of body function, body structure, and activities and participation:
- Body function:
- Evaluate impairments in gait biomechanics.
- Evaluate impairments in joint function as determined by range of motion and muscle strength.
- Body structure:
a. Evaluate muscle volume change on pre- and postoperative MRI scans and correlate these findings with body image, health-related quality of life, activity limitations, and functional impairments.
- Activities and participation:
- Objectify activity limitations by walking speed, and energy cost.
- Objectify balance and mobility as measured by Timed Up and Go (TUG) test and Timed Up and Down Stairs (TUDS) test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Treated with surgical resection for primary non-metastatic extremity STS at the Amsterdam UMC between 2010-
- •Being able to visit the Amsterdam UMC, location AMC once or twice.
- •Pregnant patients must agree to be scheduled 5 months after their pregnancy ends.
排除标准
- •Patients who cannot maintain 6 minutes of walking will be excluded from the 6-minute walk test.
结局指标
主要结局
Range of motion in degrees
时间窗: Baseline
Rang of motion in degrees wil be assessed during the physical examination using a goniometer
Gait biomechanics
时间窗: Baseline
A 3D gait analysis will be conducted. Ground reaction forces will be captured using two force plates embedded in the center of the walkway. Three valid gait trials will be collected (meaning a clear strike on the force plate(s)). For each trial, data on joint angles and net joint moments (via inverse dynamics) and powers around the hip, knee, and ankle will be calculated. Data will be averaged over three trials to represent the outcome. Also, spatiotemporal gait parameters, such as step length (m) step width (m) and walking speed (m/s} will be calculated.
Limb circumference in cm
时间窗: Baseline
Limb circumference in cm will be measured during the physical examination
Muscle strength in newton measured with a handheld dynamometer
时间窗: Baseline
A handheld dynamometer will be used to measure muscle strength during the physical examination. The participant will be asked to lie or to sit in a specific position and resistance will be applied depending on the muscle group to be tested. The dynamometer will be held perpendicular to the tested limb and the participant will be asked to actively perform a maximum contraction against the dynamometer. The participants will be instructed to push as hard as they can, and the examiner will apply equal force to that of the participant. On each muscle group, three trials will be performed, and the highest record among the three trials will be recorded. Newton (N) will be used to express muscle strength.
Muscle strength tested with the MRC scale
时间窗: Baseline
Based on the clinician's assessment of the normal strength of the muscle group under examination, the scale rates muscle strength on a scale of 0 to 5, with 0 representing no visible contraction and 5 representing a movement against complete resistance.
Muscle strength in newton meters measured with a Biodex dynamometer.
时间窗: Baseline
Quantitative force of muscles in arms or legs will be assessed using a Biodex dynamometer. The measures will be performed on both sides. On each muscle group, three trials will be performed, and the highest recorded value will be used for the analysis. Peak torque will be calculated and recorded in newton meters (Nm). Peak torque is defined as the highest torque output produced by muscle contraction during a repetition.
Change in muscle volume between preoperative and postoperative MRI scans
时间窗: Baseline
The change in muscle volume between preoperative and postoperative MRI scans will be determined.
Walking energy cost in J/kg/m
时间窗: Baseline
Walking energy cost in J/kg/m will be determined during a 6-minute walk test with simultaneous gas analysis. The oxygen uptake (VO2) and carbon dioxide production (VCO2) are measured breath-by-breath using a portable gas analysis system. First, the energy consumption will be measured for 8 minutes while the subjects are sitting on a chair. Then, the energy cost will be measured while subjects are walking during a 6-minute walk test at a comfortable, self-selected speed on an indoor oval route.
Walking speed in m/s
时间窗: Baseline
Walking speed wil be assessed during the 6-minute walk test. It will be measured and calculated as the average speed over the steady state period.
Time Up and Go (TUG) test
时间窗: Baseline
In the TUG test, the time (in seconds) required for a patient to get up from a chair, walk 3 meters to a marked point on the ground, turn, walk back to the chair, and sit down will be recorded.
Timed Up and Down Stairs (TUDS) test
时间窗: Baseline
In the TUDS test, the time (in seconds) required for a patient to go up a flight of stairs quickly and safely, turn around on the top step, and descend to the bottom step with both feet landing on the ground will be recorded.
Body image as assessed by the Body Image Scale (BIS)
时间窗: Baseline
Body image after STS resection will be evaluated with the Body Image Scale (BIS). This questionnaire consists of 10 questions about body image. For each question, the patient has to choose between 'not at all' (score 0), 'a little' (score 1), 'quite a bit' (score 2), and 'very much' (Score 3). In total, a score between 0 and 30 can be achieved with 0 indicating no distress or symptoms and 30 indicating the highest level of distress and symptoms
Health-related quality of life (QoL) as assessed by the Patient Reported Outcome Measurement Information System-Computerized Adaptive Test (PROMIS-CAT)
时间窗: Baseline
Health-related QoL and activity limitations will be assessed using the PROMIS-CAT health domains: physical functioning, social role participation, pain interference, fatigue, upper extremity, and emotional distress (anxiety and depression). PROMIS instruments are scored with T-scores, which are standardized to the general population. The average of the reference population is set at 50 points, with a standard deviation of 10.
Quality of life as assessed by the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) questionnaire
时间窗: Baseline
This questionnaire is divided into two sections: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system consists of five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are five levels for each dimension. Patients will be asked to check the box next to the most suitable statement in every one of the five dimensions. For the EQ-VAS, patients will assess their health on a vertical visual analogue scale from 0 to 100 (0 being the worst and 100 being the best imaginable health).
Level of pain as assessed by the Numeric Rating Scale (NRS)
时间窗: Baseline
The level of pain will be assessed using the Numeric Rating Scale (NRS) 0 to 10. The pain will be measured at four intervals, with 0 being no pain at all and 10 being the worst pain imaginable: currently (1), average last week (2), severity pain when worst (3) or least (4).
次要结局
- Involvement of adjacent structures(Baseline)
- Tumor depth(Baseline)
- Treatments(Baseline)
- Complications(Baseline)
- Patient demographics(Baseline)
- Body Mass Index (BMI) in kg/m2(Baseline)
- Tumor characteristics(Baseline)
- Tumor size in cm(Baseline)
- Tumor volume in cm³(Baseline)
研究者
Floortje Verspoor
Clinical researcher
Amsterdam UMC, location AMC
