Clinical trial NCT06962072: Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma
Official title: Body Image, Health-related Quality of Life, and Function After Soft Tissue Sarcoma Resection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Soft Tissue Sarcoma
Keywords: Soft tissue sarcoma
Body image
Quality of life
Function
Functioning
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for primary non-metastatic extremity STS through surgical resection, with or without (neo-) adjuvant radiotherapy, between 2010-2021.

Brief summary: 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.

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.

Primary outcomes:
measure: Gait biomechanics
timeFrame: Baseline
measure: Range of motion in degrees
timeFrame: Baseline
measure: Limb circumference in cm
timeFrame: Baseline
measure: Muscle strength in newton measured with a handheld dynamometer
timeFrame: Baseline
measure: Muscle strength tested with the MRC scale
timeFrame: Baseline
measure: Muscle strength in newton meters measured with a Biodex dynamometer.
timeFrame: Baseline
measure: Change in muscle volume between preoperative and postoperative MRI scans
timeFrame: Baseline
measure: Walking energy cost in J/kg/m
timeFrame: Baseline
measure: Walking speed in m/s
timeFrame: Baseline
measure: Time Up and Go (TUG) test
timeFrame: Baseline
measure: Timed Up and Down Stairs (TUDS) test
timeFrame: Baseline
measure: Body image as assessed by the Body Image Scale (BIS)
timeFrame: Baseline
measure: Health-related quality of life (QoL) as assessed by the Patient Reported Outcome Measurement Information System-Computerized Adaptive Test (PROMIS-CAT)
timeFrame: Baseline
measure: Quality of life as assessed by the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) questionnaire
timeFrame: Baseline
measure: Level of pain as assessed by the Numeric Rating Scale (NRS)
timeFrame: Baseline
Secondary outcomes:
measure: Patient demographics
timeFrame: Baseline
measure: Body Mass Index (BMI) in kg/m2
timeFrame: Baseline
measure: Tumor characteristics
timeFrame: Baseline
measure: Tumor size in cm
timeFrame: Baseline
measure: Tumor volume in cm³
timeFrame: Baseline
measure: Involvement of adjacent structures
timeFrame: Baseline
measure: Tumor depth
timeFrame: Baseline
measure: Treatments
timeFrame: Baseline
measure: Complications
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References: