Body image, health-related quality of life, and function after soft tissue sarcoma resection

Soft tissue sarcomas (STS) are a heterogeneous group of mesenchymal tumors,
comprising over 50 types, which account for approximately 1% of all adult
cancers. Last year, 799 new STS cases were presented in the Netherlands, of
which 331 (40%) were localized in the extremities. Approximately 75% of trunk
and extremity STS are aggressive and infiltrative (high-grade) tumors. STS has
about 60% overall survival and 73% metastasis-free survival at 5 years.

The treatment of high-grade extremity STS consists of a (wide) excision with
clear margins with or without (neo-) adjuvant radiotherapy and/or (neo-)
adjuvant chemotherapy.The resection margins may influence patients* overall
survival, but it also determines their body image and quality of life,
especially when limb function must be sacrificed to achieve sufficient
resection margins. This causes impairments in body structure and function as
well as limitations in activities and participation as defined by the
International Classification of Functioning, Disability, and Health (ICF).
(Neo-)adjuvant radiotherapy increases the probability of tumor-free margins,
resulting in a lower risk of local recurrence. However, radiotherapy is
associated with significant side effects (such as wound healing problems,
infections, risk of reoperation and lymphatic dysfunction). Recently, a
subgroup analysis of patients with high-risk STS showed a survival benefit of
(neo-)adjuvant chemotherapy. This benefit should outweigh the disadvantages of
chemotherapy. Since convincing evidence for the best treatment (including
optimal surgical margins, (neo)adjuvant radiotherapy and chemotherapy) is
lacking, decisions should be based not only on oncologic outcome measures
(local recurrences and survival), but also on self-perception, quality of life
and functioning.

Patients want to know more about their expected recovery, ability to walk and
function in daily life, at the time of surviving their malignancy. This is a
common question asked at the outpatient clinic with no clear answer. There are
some studies on health-related quality of life and functioning after STS
resections. However, these studies assessed quality of life with general
non-sarcoma-specific questionnaires and did not evaluate function with
objective outcome measures. Disease-specific measures to assess the impact of
STS and their treatment(s) on patients' quality of life are not yet available.
These measures could provide more specific insight into the unique challenges
faced by this patient population. The EORTC is currently exploring how to
design sarcoma-specific questionnaires. In addition, many sarcoma survivors
have body image issues after surgery. However, very little attention has been
paid to this aspect.

Regarding objective measurements, the effect of sarcoma treatments on walking
was reported in a few small, heterogeneous studies. These studies focused on
bone sarcoma patients and showed abnormal gait pattern after sarcoma
resections. Robinson et al. described a functional gait score after STS
resections, but they did not provide specific information on gait pattern.
There is a lack of knowledge about gait pattern and other objective
walking-related outcomes after STS resections.

Furthermore, many factors have been identified that may affect health-related
quality of life in cancer survivors. For example, in a study with 782 cancer
survivors, lower education level, household income and non-white race were
correlated with lower physical and mental quality of life. However, no
information is available on factors associated with body image and
health-related quality of life in survivors of STS.

By assessing body image, health-related quality of life, walking ability, and
functioning in daily life after STS resections and evaluating these outcomes
with more objective outcome measures (gait, energy expenditure while walking,
muscle strength, range of motion, etc.), patients and STS professionals gain a
broad understanding of the personalized risks and benefits of STS treatment(s)
based on patient age, tumor size, tumor depth, and histology. In addition,
identifying factors associated with worse outcomes may help healthcare
providers identify patients at risk, leading to appropriate interventions and
timely referral.

It is hypothesized that adequate information about body image, health-related
quality of life, walking ability and functioning in daily life after STS
resections leads to more realistic expectations of treatment outcomes for both
patients and STS professionals. It reduces uncertainty about the risks and
benefits of STS treatments and optimizes individual patient education and care.
More knowledge about these aspects can improve surgical decisions,
reconstructive techniques, psychosocial support and rehabilitation for these
patients.

Primary objectives :

1- To assess body image, health-related quality of life, self-reported
activity limitations, and pain after STS resections as defined in the ICF
domains.
2- 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:

a) Evaluate impairments in gait biomechanics.
b) 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:

a) Objectify activity limitations by walking speed, and energy cost.
b) Objectify balance and mobility as measured by TUG and TUDS.

Secondary objectives:

1- To identify factors associated with body image, health-related quality
of life and functioning in extremity STS survivors.
2- To compare body image, health-related quality of life and functioning
between patients who were treated with and without
radiotherapy.

This is a cross-sectional follow-up study. All records of consecutive
non-metastatic extremity STS patients that had a surgical resection, between
2010-2021 at the Amsterdam UMC will be evaluated. Survivors will be approached
to take part in this study by phone, followed by a letter explaining the study
including an informed consent form.

The participants can either fill out the self-reported questionnaires (BIS,
PROMIS-CAT, EQ-5D-5L, NRS) at home through the internet (using EPIC/Castor) or
on a tablet at the outpatient clinic with the help of the investigator. All
self-reported questionnaires used in this study are in Dutch. However,
participants can also choose to fill out the questionnaires in another language.

The participants will be asked to visit the outpatient clinic for a physical
examination (to assess joint range of motion, limb circumferences, balance and
mobility with 'timed up and go test* (TUG) and *timed up and down stairs*
(TUDS), isometric muscle strength using hand-held dynamometry, and manual
muscle strength (MRC)). Computer-based questionnaires can be completed at the
outpatient clinic if not already done at home. This part of the study will be
performed at the Department of Orthopedic Surgery and Sports Medicine,
Amsterdam UMC, the Netherlands. During the same visit, patients will have a 3D
gait analysis (to assess gait biomechanics), muscle strength assessment using a
Biodex dynamometer, and a 6-minute walk test (to assess walking speed and
walking energy cost) at the rehabilitation department.

The total study period depends on the time needed for data collection, which
will take about one to two years.

Results from the self-reported questionnaires and muscle strength using a
Biodex dynamometer will be compared to the general population means. Results on
walking speed, walking energy cost, physical examination, and gait biomechanics
will be compared within patients (contralateral healthy vs treated limb),
between patients after upper extremity and lower extremity STS resection, and
to general population means. Results from muscle strength assessment using a
Biodex dynamometer will be compared to 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 quality of life questionnaires

The risks of participating in this study are negligible. The tests used in this
study have no serious side effects. The burden is also minimal. Patients need
to visit the Amsterdam UMC, location AMC, once or twice. The questionnaires can
be completed either at home or at the outpatient clinic. Completing all
questionnaires takes 30 minutes, physical examination including handheld
dynamometer takes 1 hour, 6-minute walk test takes 30 minutes, gait analysis
takes 2 hours, and muscle strength assessment with Biodex dynamometer takes 2
hours. This is the first study to evaluate body image and objective functional
outcome measures after STS resections. This study will give STS patients
insight into their body image, quality of life and functioning. This insight
may improve their acceptance and create new rehabilitation opportunities
(through improved knowledge of individual deficits). The study can only be
conducted with these specific patients because STS are rare and only treated in
designated *expertise centers* (ERN).