Quality of Life Clinical Trial
Official title:
Long Term Morbidity and Quality of Life After Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas: a Prospective Observational Study
No prospective data exist about long term morbidity and quality of life after multivisceral
surgical resection for retroperitoneal soft tissue sarcoma (RSTS).
In order to assess the safety of this surgical approach and the effect on the Quality of Life
over the long period we propose a prospective observational study.
The hypothesis is that the surgical treatment has no significant impact in determining a
lower Quality of Life in the long term.
Objectives Primary objective Estimate the difference between baseline and 4 and 12 months
scores of the "global health status / QoL" scale in patients primarily treated for localized
RSTS, as determined in QLQ-C30 version 3.0.
Secondary objectives
- Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of
renal failure.
- Evaluate the difference between baseline and 4 and 12 months scores of DN4 / LEFS / BPI
questionnaires.
- Evaluate the difference between baseline and 4 and 12 months scores of the following
scales from QLC-C30: PF2, RF2, EF, CF, SF, FA, FI.
- Evaluate the difference between baseline and 4 and 12 months scores of the following
scales and single items from QLC-C29: Blood and mucus in stool, Stool frequency, Sexual
interest, Impotence, Dyspareunia.
- To correlate the surgical resection pattern (number and type of organs resected) and the
tumor features (size, grading and histological subtype) with the long-term morbidity and
quality of life.
Eligibility Inclusion criteria
- Adult patients (age > 18 years) with primary localized RSTS surgically treated at our
institution
- Written, voluntary, informed consent
Exclusion criteria
- Recurrent disease
Study description This is an observational study aimed to prospectively evaluate the long
term morbidity of aggressive surgical approach to RSTS and the impact over the patients'
quality of life. Consecutive patients candidate to surgery for primary RSTS will be offered
to be enrolled. We plan to include all the RSTS patients consecutively operated on for
primary retroperitoneal sarcoma from first accrual on up to the 24 months after the study
start.
At the entrance of the study, an informed written consent will be obtained. Study
participants will be asked to complete four self-filled in one-off questionnaires (see "Study
parameters" paragraph).
Study parameters Study parameters EORTC QLQ-CR29 and EORTC QLQ C30 questionnaires (baseline,
4 mos, 12 mos) LEFS questionnaire (baseline, 4 mos, 12 mos) BPI questionnaire (baseline, 4
mos, 12 mos) DN4 questionnaire (baseline, 4 mos, 12 mos) Serum creatinin (baseline, 4 mos, 12
mos) Morbidity events (4 mos, 12 mos) Neurologic exam of lower limbs (baseline, 4 mos, 12
mos) Disease status (4 mos, 12 mos)
* In case of preoperatory complementary treatment, the questionnaires will be administrated
just before the beginning of the treatment.
- Quality of Life: the core questionnaire, the EORTC QLQC30,is an extensively validated
questionnaire for the assessment of health related quality of life in cancer patients
(Aaronson 1991). It contains both functional (physical, role, cognitive, emotional,
social), and physical symptom multidimensional scales (fatigue, pain, and nausea and
vomiting) as well as two single item "global health status" and "quality of life"
scales, plus several single-item symptom measures. The QLQ-CR29 is a condition specific
module (colo-rectal disease) developed to be used in conjunction with EORTC QLQC30; it
is made up of 29 items for a total of four scales assessing urinary frequency, faecal
seepage, stool consistency and body image as well a number single items scales. Both the
tools are available and validated in the Italian language.
- Femoral Impairment: the dedicated questionnaire (Lower Extremity Functional Scale -
Italian Version, LEFS questionnaire) will investigated daily life activities that
require ad adequate function of knee joint stability and quadriceps strength as a
surrogate of motor impairment of homolateral femoral nerve.
- Chronic Pain Syndrome: the Italian version of the 'Brief Pain Inventory Short form"
(BPI, attached) ( ) will be administered in order to obtain information on pain status
at censored time (basal, 4 and 12 months after surgery values).
- Neuropathic Pain: the Italian version of "Douleur Neuropathique en 4 Questions" (DN4,
attached) will be administered in order to obtain information on neuropathic pain at
censored time (basal, 4 and 12 months after surgery scores).
- Long term morbidity: morbidity events will specifically regard femoral nerve impairment
at physical examination, abdominal complications, sexual life and physiological
functions. Renal failure in particular will be investigated by renal function blood
tests monitoring and glomerular filtration rate (GFR) calculated according to
Cockroft-Gault and simplified MDRD (Modification of Diet in Renal Disease) methods.
Serum creatinine value will also be registered. Renal failure will be defined according
to National Kidney Foundation 2002 criteria (Stage 2 or higher), and classified
according to GFR thresholds.
- Disease status will be recorded and in case of local and/or distant relapse the date of
events will also be retrieved.
Statistical considerations Statistical analyses
1. Primary end-point The two-sided 95% confidence interval (95%CI) of the paired difference
between baseline and 4 (or12) months scores will be calculated for the primary outcome
scale variables (items "29" and "30" QLQ-C30).
2. Secondary end-points Descriptive statistics and frequency tabulation were used to
summarize patient characteristics and long term morbidity profile. Continuous variables
will be described with appropriate summary statistics such as the mean, median, standard
deviation, minimum and maximum. Categorical variables will be tabulated with frequencies
and percentages. The probabilities of renal failure and femoral neuropathy will be
estimated by the corresponding relative frequencies; their corresponding 95% confidence
limits will be calculated using the exact method, i.e. taking into account the binomial
distribution of proportions. The binary associations between the surgical resection
pattern (number and type of organs resected) and the tumor features (size, grading and
histological subtype) will be tested by using exact chi-square test. As regards the
quantitative parameters measured over time, summary statistics (mean, median, standard
deviation, minimum and maximum) or frequencies and percentages - as appropriate for the
type of data - will be summarized by each time point; mixed models will be used to
analyze the longitudinal measurements, allowing to take into account the within subject
correlation and to straightforwardly analyze unbalanced data that may arise in the
study.
Interim Analysis We plan to performed an interim cross-sectional analysis at the end of
patient enrollment in order to describe the study population at baseline, according to the
primary and secondary endpoints.
Sample size
We plan to include all the RSTS patients consecutively operated on for primary
retroperitoneal sarcoma from first accrual on for the next 24 months (about 60 patients
estimated.
A sample size of 60 patients allows the estimation of a two-sided 95,0% confidence interval
for the paired difference between baseline and post treatment scores with a precision (half
CI width) of 0.25 times the standard deviation of the difference.
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