Soft tissue sarcoma, Malignant soft tissue tumor Soft tissue cancer
Conditions
Interventions
In this study, the consequences of the surgical removal of a soft tissue sarcoma, including atypical lipomatous tumors, are investigated. During this procedure, the tumor is typically removed with a m
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet all the following criteria:Adult (>18 years) treated with curative intent by surgical resection for a soft tissue sarcoma, including atypical lipomatous tumors (ALT)/well differentiated liposarcoma, from 2010 onwards and with a minimum follow-up of 2 years after tumor resection. Had a tumor located in the upper extremity (including the shoulder girdle) or lower extremity (including the hip area). 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
Exclusion criteria: Patients who are unable to perform a particular test will only be excluded from that test.Exclusion criteria for the 6-minute walk test Patients who cannot maintain 6 minutes of walking will be excluded from the 6-minute walk test.Exclusion criteria for the 6-minute walk test and gait analysisPatients who had a soft tissue sarcoma in the upper extremity will be excluded from the gait analysis and 6-minute walking test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body image and health-related QoL (subjective outcomes/endpoints): Body image, health-related QoL, self-reported activity limitations, and pain: Body image will be assessed using the Body Image Scale (BIS). Health-related QoL and activity limitations will be assessed using PROMIS-CAT and Eq-5d-5L questionnaires. Pain will be assessed using the numeric rating scale (NRS). These questionnaires will be classified under the ICF domains.Functioning (objective parameters/endpoints) will be classified under the ICF domains of body functions, body structure, and activities and participation:Body function:Impairments in gait biomechanics will be assessed using 3D gait analysis. Patients who had an STS of the upper extremity will be excluded from gait analyses. Impairments in joint function will be assessed with a physical examination of both upper and lower extremities, including range of motion (shoulder, elbow, wrist, hip, knee, and ankle), limb circumference, and muscle strength assessed by manual muscle testing (Medical Research Council (MRC)) and a handheld dynamometer. Muscle strength will also be quantified with a Biodex dynamometer (fixed force gauge). In patients after upper extremity STS resection, grip strength will also be measured using a handgrip dynamometer. Body structures: Muscle volume change will be evaluated on pre- versus postoperative MRI scans. Additionally, tumor characteristics will be evaluated on preoperative MRI scans.Activities and participation: Objectively measured walking ability will be assessed in terms of walking speed and walking energy cost, as measured during a 6-minute walk test with simultaneous gas analysis. Patients who had an STS of the upper extremity will be excluded from this test. Objectively measured balance and mobility will be assessed using the Timed Up and Go (TUG) test and the Timed Up and Down Stairs (TUDS) test. These tests are part of the physical examinat | — |
Secondary
| Measure | Time frame |
|---|---|
| The influence of different variables (e.g., gender, ethnicity, education level ....) on body image, health-related quality of life and functioning.The differences in outcomes regarding body image, health-related quality of life, and functioning between patients after extremity STS resection with or without radiotherapy. | — |
Countries
Netherlands
Contacts
Public ContactM Makdis Mouso
Amsterdam UMC
Outcome results
None listed