Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical resection with or without radiotherapy and/or chemotherapy.
- Who it may be relevant to
- Registry conditions: Soft Tissue Sarcoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Body Image, Health-related Quality of Life, and Function After Soft Tissue Sarcoma Resection
Overview
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.
Detailed description
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:
1. Evaluate impairments in gait biomechanics. 2. 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:
1. Objectify activity limitations by walking speed, and energy cost. 2. Objectify balance and mobility as measured by Timed Up and Go (TUG) test and Timed Up and Down Stairs (TUDS) test.
Secondary objectives:
* To identify factors associated with body image, health-related QoL and functioning in extremity STS survivors. * To compare body image, health-related QoL and functioning between patients who were treated with and without radiotherapy.
Srudy design:
This is a cross-sectional follow-up study. All records of consecutive non-metastatic extremity STS patients who underwent surgical resection between 2010 and 2021 at the Amsterdam UMC will be evaluated. Both deceased patients and survivors are included to obtain a realistic picture of the entire population. Survivors (approximately N = 125-150) will be approached to take part in this study by phone, followed by a letter explaining the study, including an informed consent form.
At baseline, patient demographics, tumor characteristics, diagnostics, and treatments will be collected. The participants can either fill out the self-reported questionnaires at home through the internet (using EPIC/Castor) or on a tablet at the outpatient clinic with the help of the investigator.
Participants will be invited to visit the outpatient clinic for a physical examination, which will include assessments of joint range of motion, limb circumference, balance, and mobility. Balance and mobility will be evaluated using the Timed Up and Go (TUG) test and the Timed Up and Down Stairs (TUDS) test. Muscle strength will be assessed using a hand-held dynamometer and the Medical Research Council (MRC) scale. Participants can complete the computer-based questionnaires at the outpatient clinic if not already completed at home. This part of the study will take place at the Department of Orthopedic Surgery and Sports Medicine.
Additionally, participants will undergo a 3D gait analysis to assess gait biomechanics, a muscle strength assessment using a Biodex dynamometer, and a 6-minute walk test to evaluate walking speed and energy cost. These assessments will be conducted at the Department of Rehabilitation.
Depending on the test, results will be compared as follows:
* Against general population means * Between patients who have undergone upper and lower extremity STS resection * Between the affected limb and the contralateral healthy limb
Additionally, the results from the objective functional tests and the MRI-scans (with tumor and pre- plus postoperative muscle specific features) will be correlated with body image and health-related QoL questionnaires. To identify factors associated with body image, health-related QoL, and functioning, we will assess whether the collected factors (baseline patients and tumor characteristics, treatments, and complications) are associated with better or worse outcomes of the questionnaires and the functional tests.
Interventions
- Procedure Surgical resection with or without radiotherapy and/or chemotherapy
The surgical resection of STS serves as the primary treatment, aiming to completely remove the tumor with a wide margin of surrounding healthy tissue to minimize the risk of recurrence. Radiotherapy and/or chemotherapy may be incorporated depending on the tumor's type, stage, and grade.
Primary outcome measures
- Gait biomechanics [Time frame: Baseline]
- Range of motion in degrees [Time frame: Baseline]
- Limb circumference in cm [Time frame: Baseline]
- Muscle strength in newton measured with a handheld dynamometer [Time frame: Baseline]
- Muscle strength tested with the MRC scale [Time frame: Baseline]
- Muscle strength in newton meters measured with a Biodex dynamometer. [Time frame: Baseline]
- Change in muscle volume between preoperative and postoperative MRI scans [Time frame: Baseline]
- Walking energy cost in J/kg/m [Time frame: Baseline]
- Walking speed in m/s [Time frame: Baseline]
- Time Up and Go (TUG) test [Time frame: Baseline]
Secondary outcome measures (9)
- Patient demographics [Time frame: Baseline]
- Body Mass Index (BMI) in kg/m2 [Time frame: Baseline]
- Tumor characteristics [Time frame: Baseline]
- Tumor size in cm [Time frame: Baseline]
- Tumor volume in cm³ [Time frame: Baseline]
- Involvement of adjacent structures [Time frame: Baseline]
- Tumor depth [Time frame: Baseline]
- Treatments [Time frame: Baseline]
- Complications [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Treated with surgical resection for primary non-metastatic extremity STS at the Amsterdam UMC between 2010-2021.
- 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.
Exclusion criteria
- Patients who cannot maintain 6 minutes of walking will be excluded from the 6-minute walk test.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Amsterdam UMC — Amsterdam
Identifiers
NCT: NCT06962072 · NL85908.018.23