Validation of EORTC QLQ-C30/BR23 for Mexican Breast Cancer HRQL

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Validation of the Mexican-Spanish version of the EORTC QLQ-C30 and BR23
questionnaires to assess health-related quality of life in Mexican women with
breast cancer
Article in European Journal of Cancer Care · February 2012
DOI: 10.1111/j.1365-2354.2012.01336.x · Source: PubMed
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Original article
Validation of the Mexican-Spanish version of the EORTC
QLQ-C30 and BR23 questionnaires to assess health-related
quality of life in Mexican women with breast cancer
ecc_1336
1..8
O. CEREZO, md, msc, clinical researcher, Clinical Research Division, Instituto Nacional de Cancerología,
Mexico City, L.F. OÑATE-OCAÑA, md, surgical oncologist and clinical researcher, Clinical Research
Division, Instituto Nacional de Cancerología, Mexico City, P. ARRIETA-JOFFE, md, fellow, Infectious Diseases
Department, Instituto Nacional de Cancerología, Mexico City, F. GONZÁLEZ-LARA, md, fellow, Infectious
Diseases Department, Instituto Nacional de Cancerología, Mexico City, M.J. GARCÍA-PASQUEL, md, fellow,
Infectious Diseases Department, Instituto Nacional de Cancerología, Mexico City, E. BARGALLÓ-ROCHA, md,
head, Breast Tumors Department, Instituto Nacional de Cancerología, Mexico City, & D. VILAR-COMPTE, md,
msc, hospital epidemiologist and associate professor, Infectious Diseases Department, Instituto Nacional de
Cancerología, Mexico City, Mexico
CEREZO O., OÑATE-OCAÑA L.F., ARRIETA-JOFFE P., GONZÁLEZ-LARA F., GARCÍA-PASQUEL M.J.,
BARGALLÓ-ROCHA E. & VILAR-COMPTE D. (2012) European Journal of Cancer Care
Validation of the Mexican-Spanish version of the EORTC QLQ-C30 and BR23 questionnaires to assess
health-related quality of life in Mexican women with breast cancer
The aim of this study was to validate the Mexican-Spanish version of The European Organization for Research
and Treatment of Cancer (EORTC) QLQ-BR23 questionnaire. The translation procedure followed EORTC
guidelines. QLQ-C30 and QLQ-BR23 instruments were completed by Mexican women with breast cancer,
attending a teaching referral cancer centre from February 2009 to January 2010. Patients were divided in two
groups: (1) Patients with early stage of breast cancer; and (2) Patients with locally advanced breast cancer
(LABC). Reliability and validity tests were performed, and validity over time (responsiveness) was conducted
in a subset of patients. Two hundred and thirty-four women (mean age, 52.3 years) completed both questionnaires. Convergent and divergent validity was adequate. Cronbach’s alpha of all multi-item scales showed
values ⱖ0.7 except for Cognitive and Breast symptoms scales (0.52 and 0.65 respectively). Patients with early
stages (n = 77) showed better functional scores and lower symptoms scores than patients with LABC (n = 157).
Score means variation after responsiveness analysis demonstrated high sensitivity to change after breast cancer
surgery. The Mexican-Spanish version of the EORTC QLQ-BR23 questionnaire is a valid and suitable instrument to estimate HRQL in patients with breast cancer.
Keywords: breast cancer, EORTC-BR23, health-related quality of life, validity, Mexico.
INTRODUCTION
Correspondence address: Diana Vilar-Compte, Departamento de Infectología, Instituto Nacional de Cancerología, Av. San Fernando 22, Col.
Sección XVI, México City 14080, D.F., México (e-mail: diana_vilar@
yahoo.com.mx).
Accepted 30 December 2011
DOI: 10.1111/j.1365-2354.2012.01336.x
European Journal of Cancer Care, 2012
© 2012 Blackwell Publishing Ltd
Breast cancer (BC) is a major public health problem. BC
has shown increased incidence rates in low- and middleincome countries, where the majority of patients are diagnosed in advanced stages of disease (Porter 2008).
Over the past few years (Vervoort et al. 2004), BC survival has improved by 7–11% and has the largest group
of female cancer survivors (Brenner 2002; Stewart &
CEREZO et al.
Kleihues 2003). Traditionally, treatment results have
focused on clinical responses, decreased frequency of
relapses, or improved survival (Loprinzi & Thome 2001;
Shapiro & Recht 2001). Recently, healthcare providers
have paid increasing attention to the long-term consequences of illness and treatment. Usually, physicians consider symptoms differently from the manner in which
patients do in terms of these consequences. Patientreported outcomes consider the patient’s opinion on
symptoms and health-related quality of life, HRQL
(Patrick & Erickson 1993; Brady et al. 1997; Wu 2000;
Yabroff et al. 2004).
Health-related quality of life is the value assigned to life
duration as modified by impairments, functional states,
perceptions and social opportunities that are influenced
by disease, injury, treatment or policy (Patrick & Erickson
1993). However, there is some agreement that HRQL is a
construct that includes at least five domains as follows:
physical; emotional; social; cognitive; general health perceptions (Wu 2000).
Health-related quality of life has been studied in BC
employing a wide array of instruments. HRQL has been
evaluated in several studies with Functional Assessment
of Cancer Therapy-General and its subscale, the Functional Assessment of Cancer Therapy-Sub-scale questionnaires (Brady et al. 1997; Lee et al. 2004). However, when
using these instruments, cross-cultural or equivalence
comparability was not always achieved. In contrast, the
European Organization for Research and Treatment of
Cancer (EORTC) Quality of life questionnaire (QLQ)
QLQ-C30 (Aaronson et al. 1993), together with its supplementary site-specific module – QLQ-BR23 (Sprangers
et al. 1996), has shown cross-cultural and equivalence
validity.
The EORTC QLQ-BR23 has been translated to Spanish
in Spain, in Colombia and in the USA, but semantic and
conceptual equivalence is not always feasible (EORTC
2010). Recently, the Mexican-Spanish version of the
QLQ-C30 and QLQ-STO22 questionnaires were validated
(Oñate-Ocaña et al. 2009), but the Mexican-Spanish
version of QLQ-BR23 has been neither translated nor validated. Consequently, the aim of this study was to translate and validate this instrument in Mexican women with
BC.
MATERIALS AND METHODS
Patients
Consecutive women with biopsy-proven breast carcinoma
attending the Breast Tumors Clinic at the Instituto
2
Nacional de Cancerología in Mexico City, between
February 2009 and January 2010 were invited to
participate.
The Instituto Nacional de Cancerología is a 125-bed
teaching, referral cancer hospital in Mexico City. More
than 3000 surgeries are performed annually, and approximately, 600–650 new BC cases are diagnosed each year;
more than 50% are diagnosed with locally advanced
disease.
Patients with in situ BC, those unable to complete or to
understand the questionnaires, or those who refused to
participate were excluded. Patients scheduled for Chemotherapy (CT), radiation, chemoradiation, and those attending immediate surgical follow-up were interviewed during
visits at the outpatient clinic. Demographic, clinical,
imaging and laboratory data were collected prospectively.
An interview and physical examination was completed at
each visit. All patients gave informed consent.
Clinical status of patients was defined according to the
6th Edition of Tumor, Node, and Metastases Staging
System of the American Joint Committee on Cancer
(American Joint Committee on Cancer 2002). Additionally, clinical status was defined as early BC (clinical stages
I and IIA), locally advanced BC (LABC) (clinical stages IIB,
III-A, -B, and -C) and metastatic disease.
The study was approved by the Institutional Review
Board at the Instituto Nacional de Cancerología (registry
number 08077INI) and was supervised by the EORTC
Quality of Life Group. Funding was provided by our Institution as part of the research funds provided for clinical
and epidemiological research. None of the authors had any
conflict of interest.
Instruments
The Mexican-Spanish EORTC QLQ-C30 version 3.0 was
used. Items 31, 35, 39 and 43 deriving from the MexicanSpanish version of EORTC QLQ-STO22 (Oñate-Ocaña
et al. 2009) were employed in an unchanged state in the
definitive version of QLQ-BR23. The remaining items were
translated according to EORTC official guidelines of rigid
forward/backward translation (Koller et al. 2007). Forward
translation was conducted by two non-medical certified
native Mexican-Spanish translators. An initial proposal of
the instrument was developed, which was pilot tested on
10 Mexican subjects with BC. The final version (MexicanSpanish and its backward translation) was revised and
approved by the EORTC Quality of Life Group. The process
was supervised at all times by the EORTC.
The QLQ-C30 (version 3) comprises a global health
status, five multi-item functional scales, and several
© 2012 Blackwell Publishing Ltd
Quality of life in patients with breast cancer
single- or multi-item symptom scales. The QLQ-BR23 is a
23-item module designed to increase the power of the
QLQ-C30 questionnaire in terms of sensitivity and specificity in patients with BC. This module assesses the
following five multi-item scales: disease symptoms; treatment side effects; body image; and sexual functioning.
Single items assess future perspective, sexual enjoyment
and hair loss (Sprangers et al. 1996; EORTC 2010). For
further information on the translation process please
contact the corresponding author.
Sample size
According to the Tabachnik and Fidell (1993) recommendation, the number of patients must be five to ten times
the number of variables in the model, bearing in mind that
estimates run in a multivariable analysis. Considering
that the main variable in the EORTC QLQ-BR23 is the
item, we needed a minimum sample size of 230 (23
items times 10). Twenty-five patients were required for
the responsiveness analysis. The questionnaires were
responded a few days before surgery on ambulatory basis
during one of the pre-operative appointments. The second
evaluation was conducted 30–45 after mastectomy during
a surgical follow-up appointment.
Data analysis
The scoring rules are the same for both questionnaires.
Data analysis was performed independently for the QLQC30 and QLQ-BR23 questionnaires. Scores for multi-item
functional or symptom scales and for single items were
calculated by linear transformation of raw scores into a
0–100 score, with 100 representing best global health,
functional status, or worst symptoms, depending on the
measuring property of each multi- or single-item scale, as
described by EORTC (Fayers et al. 2001). A high score for
a functional scale represents a higher HRQL. However, a
high score for a symptom scale represents higher level of
symptoms. In order to handle missing data we used the
imputation method across multivariate technique, in
accordance with the EORTC scoring manual (Fayers et al.
2001).
Discriminant validity was evaluated with itemconvergent validity for each scale assessed by means of
employing the correlation between each item with items
belonging to its own scale. Divergent validity was evaluated by correlating each item with items belonging to any
other scale. Criteria for success for any item were considered when the correlation between an item and its own
scale was significantly higher than its correlation with
© 2012 Blackwell Publishing Ltd
any other scale. These analyses were done using nonlinearised item scores. Correlation assessment between
single items was obtained with the Spearman correlation
coefficient, and Cronbach’s a was used for multi-item
correlation. The extent which both questionnaires reach
correlations was assessed by construct validity.
Clinical validity was evaluated by the extent to which
linearised scale scores were able to discriminate among
clinically distinct groups of patients. The differences
among groups were tested with chi-squared, and Kruskal–
Wallis tests as appropriate.
Validity was also evaluated comparing the differences of
scale scores over time. Basal measurement was compared
with a new measurement performed after radical mastectomy in a subset of patients.
Any probability value ⱕ0.01 was considered significant
because multiple comparisons, considering that Bonferroni correction was not used. Two-tailed statistics were
considered in all cases. Stata version 9.1 (StataCorp 2009.
Stata Statistical Software Release 9.1, Stata Corp. LP.,
College Station, TX, USA) was used.
RESULTS
Patients
Two hundred thirty-four women were included in the
study; mean age was 52.9 (standard deviation 11.8) years.
All women completed the QLQ-C30 and QLQ-BR23 questionnaires. Clinical stage was classified as early (n = 77)
and LABC (n = 157) BC. On entrance into the study, 142
patients had already received neo-adjuvant CT (60.7%). Of
patients treated with neo-adjuvant CT, 53 (37.3%) did not
show an appropriate response to CT and underwent
further treatment (pre-operative radiation, n = 19 or preoperative concomitant chemoradiation, n = 34). Clinical
and demographical characteristics are shown in Table 1.
All recruited women accepted and answered both selfadministered questionnaires. There were approximately
120 (0.96%) missing values (out of 12 402 possible answers)
for the entire number of questionnaires without any specific pattern. Missing values were randomly distributed.
Response time for both questionnaires was <20 min in all
cases (19.5 min; 95% confidence interval, 14.2–22.5).
Reliability and validity
Multi-trait analysis demonstrated Cronbach’s alpha
values more than 0.7 in all but two scales of QLQ-C30
(Cognitive and Nausea/vomiting) and one of QLQ-BR23
(Breast symptoms). A good convergent and discriminant
validity was obtained (Table 2).
3
CEREZO et al.
Table 1. Demographic and clinical data
Age (mean ⫾ SD)
Marital status, n (%):
Single
Married
Divorced
Widow
Number of children, n (%)
Without children
1–4
>4
Employment, n (%)
Unemployed
Employee
Household
Education, n (%)
Illiterate†
Elementary school
High school
Professional studies
Monthly income (mean, US dollars, 2009) (mean ⫾ SD)
Diabetes, n (%)
Hypertension, n (%)
Past deep venous thrombosis, n (%)
Body mass index (kg/m2) (mean ⫾ SD)
Neo-adjuvant chemotherapy, n (%)
Concomitant chemoradiation*
Radiation*
Chemotherapy/Trastuzumab, n (%)
Trastuzumab, n (%)
Hemoglobin (g/dL)
Leucocytes (cells/mm3)
Lymphocytes (cells/mm3)
Serum albumin (g/dL)
Early stage BC
(n = 77)
Locally advanced
BC (n = 157)
54.2 ⫾ 11.9
52.3 ⫾ 11.6
22 (28.6)
40 (51.9)
9 (11.7)
6 (7.8)
40 (25.5)
76 (48.4)
24 (15.3)
17 (10.8)
23 (29.8)
50 (64.9)
4 (5.3)
25 (15.9)
104 (6.2)
28 (17.8)
6 (7.8)
10 (13)
61 (79.2)
14 (8.9)
32 (20.4)
111 (70.7)
12 (15.6)
38 (49.4)
20 (25.9)
7 (9.1)
329.7 ⫾ 49.3
13 (16.8)
25 (32.5)
4 (5.2)
29 ⫾ 5
9 (11.7)
0 (0)
1 (11.1)
0 (0)
0 (0)
14.2 ⫾ 1.3
6860 ⫾ 1852
2047 ⫾ 734
3.9 ⫾ 0.3
16 (10.2)
72 (45.9)
45 (28.7)
14 (8.9)
336 ⫾ 49.3
31 (19.8)
42 (26.8)
16 (10.2)
27.7 ⫾ 5.5
113 (71.9)
34 (30.1)
18 (15.9)
14 (8.9)
6 (3.8)
13.1 ⫾ 1.2
5157 ⫾ 2047
1422 ⫾ 733
3.8 ⫾ 0.23
P
0.24
0.7
<0.01
0.3
0.3
0.3
0.59
0.36
0.19
0.10
<0.0001
<0.0001
0.001
<0.0001
<0.0001
<0.0001
0.03
*Patients with poor response to chemotherapy were also treated with radiation or concomitant chemoradiation before surgery.
†Illiterate patients were escorted with a family member and one member of the team. Each question was read loud and repeated if
the patient requested so.
Advanced stage BC, stage IIB–IIIC; BC, breast cancer; Early stage BC, stage I–IIA; P, probability value; SD, standard deviation.
A strong correlation was observed between questionnaires for emotional functioning (QLQ-C30) with body
image and future perspective scales (QLQ-BR23) (0.47 and
0.43, P-value < 0.0001 respectively), and appetite loss
(QLQ-C30) with systemic therapy side effects and breast
symptoms for QLQ-BR23 (0.59 and 0.54, P < 0.0001
respectively).
Table 4 shows the mean scores of both questionnaires
after responsiveness analysis according to clinical stage
(early and locally advanced BC). The sphericity assumption showed that data came from the same source of
patients (Mauchly test >0.05). Eleven of the 23 scales
showed change over time.
DISCUSSION
Clinical validity
Assessment of clinical data with scores from multi-item
scales and single items are depicted in Table 3. Patients
with LABC presented higher scores in Nausea and Vomiting, and in Fatigue and Pain scales for QLQ-C30, and
showed higher scores in Breast and Arm symptoms, and in
systemic therapy side effects scales. Lower scores were
observed in Body image and Sexual functioning scales.
4
With an estimated 1.5 million new cases worldwide annually and a relatively good prognosis, BC is the most prevalent cancer in the world (Jemal et al. 2007). Early detection
and treatment have increased overall and disease-free survival (Veronesi et al. 2005).
Health-related quality of life is considered an important
endpoint in cancer clinical trials. There is a need to complement conventional clinical outcomes with information
© 2012 Blackwell Publishing Ltd
Quality of life in patients with breast cancer
Table 2. EORTC QLQ-C30 and QLQ-BR23; convergent and discriminant validity of multi-item scales (n = 234)
QLQ-C30
Global health status
Functional scales
Physical
Role
Emotional
Cognitive
Social
Fatigue
Nausea & vomiting
Pain
QLQ-BR23
Multi-item scales
Body image
Sexual functioning
Systemic therapy side effects
Breast symptoms
Arm symptoms
Item-own scale
correlations*
Item-other scale
correlations*
Multi-item
correlations†
0.92
0.05–0.41
0.94
0.63–0.83
0.92
0.73–0.88
0.85
0.92
0.73–0.83
0.45
0.89
0.04–0.70
0.12–0.72
0.01–0.54
0.01–0.47
0.06–0.45
0.06–0.74
0.16–0.9
0.02–0.74
0.81
0.8
0.83
0.52
0.81
0.71
0.57
0.74
0.75–0.88
0.91
0.49–0.67
0.51–0.77
0.70–0.83
0.01–0.45
0.03–0.53
0.07–0.51
0.04–0.59
0.04–0.61
0.89
0.76
0.7
0.65
0.7
*Spearman correlation coefficient.
†Cronbach’s alpha (b).
EORTC, European Organization for Research and Treatment of Cancer; QLQ, Quality of life questionnaire.
Table 3. Known group comparison: health-related quality of life mean scores by clinical stage
QLQ-C30
Global health status
Functional scales
Physical
Role
Emotional
Cognitive
Social
Fatigue
Nausea & vomiting
Pain
Single items
Dyspnoea
Insomnia
Appetite loss
Constipation
Diarrhoea
Financial difficulties
QLQ-BR23
Multi-item scales
Body image
Sexual functioning
Systemic therapy side effects
Breast symptoms
Arm symptoms
Single items
Sexual enjoyment
Future perspective
Upset by hair loss
Early stage BC
(n = 77)
Locally advanced
BC (n = 157)
P
64.1 (23.8)
62.3 (26.7)
0.58
74.7 (20.4)
60.8 (32.5)
79.1 (18.3)
92.2 (13.7)
80.3 (26.6)
21.3 (16.4)
18.8 (10.9)
31 (21.6)
71.5 (21.7)
54.9 (30.9)
75 (24.3)
85.5 (20.3)
71.9 (29.5)
27.4 (22.7)
22.3 (20.1)
36.9 (25.6)
0.73
0.401
<0.01
0.2
0.2
0.24
0.87
0.25
16.5 (22)
26.8 (26.5)
18.8 (10.9)
18.2 (24.5)
6.5 (13.2)
31.2 (27.2)
16.2 (26.8)
30.6 (29.7)
22.3 (15.1)
18.1 (26.7)
3.8 (12.3)
42.2 (35.9)
0.1
0.51
0.88
0.73
<0.05
<0.01
84.3 (15.6)
8 (15.4)
19.2 (13.4)
29.6 (15.5)
32.9 (22.3)
72.1 (26.3)
12.4 (19.9)
22.6 (17.7)
33.4 (19.9)
40 (23.1)
0.1
0.71
0.19
0.85
0.19
8.7 (17.4)
51.5 (32.7)
8.2 (19.6)
13.9 (27.5)
46.6 (37.2)
13.5 (29.2)
0.06
0.08
0.22
Advanced stage BC, stages IIB–IIIC; BC, breast cancer; Early stage BC, stages I–IIA; P, probability value; QLQ, Quality of life
questionnaire.
© 2012 Blackwell Publishing Ltd
5
CEREZO et al.
Table 4. Responsiveness of EORTC QLQ-C30 and QLQ-BR23: mean scores by clinical stage before and after surgical treatment of breast
cancer
QLQ-C30
General health status
Functional scales
Physical
Role
Emotional
Cognitive
Social
Fatigue
Nausea & vomiting
Pain
Single items
Dyspnoea
Insomnia
Appetite loss
Constipation
Diarrhoea
Financial difficulties
QLQ-BR23
Multi-item scales
Body image
Sexual functioning
Systemic therapy side effects
Breast symptoms
Arm symptoms
Single items
Sexual enjoyment
Future perspective
Upset by hair loss
Early stage BC (n = 11)
Locally advanced BC (n = 14)
Before
After
Before
After
P
64 (23.8)
70.6 (26.9)
62.3 (26.7)
76.7 (16.1)
<0.001
74.7 (20.4)
60.8 (32.5)
79.1 (18.3)
92.2 (13.7)
80.3 (26.6)
21.4 (16.4)
18.8 (10.9)
31 (21.6)
95.3 (8.45)
92.6 (16.3)
91.2 (15.5)
97.8 (7.3)
95.5 (11.7)
6.9 (14.6)
6.22 (10.4)
9.1 (18)
71.4 (21.7)
54.9 (30.1)
75 (24.3)
85.5 (20.3)
71.8 (29.5)
27.4 (22.7)
22.3 (15.1)
36.9 (25.6)
92.9 (12.8)
91.5 (17.1)
91.2 (16.3)
93.8 (13.6)
90.8 (19.8)
8.5 (15.3)
7.2 (12)
10 (17.8)
<0.001
<0.001
<0.05
0,88
<0.01
<0.01
<0.001
<0.001
16.5 (22)
26.8 (26.5)
18.8 (10.9)
18.2 (24.5)
6.5 (13.3)
31.2 (27.2)
4.3 (13.6)
11.7 (23.4)
6.22 (10.4)
5.2 (14.3)
2.2 (8.2)
9.5 (23.5)
16.2 (26.8)
30.6 (29.7)
22.3 (15.1)
18.1 (26.8)
3.9 (12.4)
42.2 (35.9)
3.2 (10)
9.4 (20.2)
7.2 (12)
7.5 (17.6)
2.7 (11)
14.8 (27.2)
<0.001
<0.01
<0.01
<0.01
<0.05
<0.001
84.3 (15.6)
8 (15.4)
19.2 (13.4)
29.6 (15.5)
32.9 (22.3)
84.6 (25.4)
11.8 (18.9)
19.2 (17)
17.7 (17)
22.6 (16.1)
72.1 (26.3)
12.5 (19.9)
22.7 (17.7)
33.4 (19.9)
40 (23.1)
75.8 (27.6)
8.5 (15.5)
17.4 (16.1)
22.1 (20.5)
20.6 (17.2)
0.75
0.6
0.69
<0.05
<0.05
8.7 (17.4)
51.5 (32.7)
8.2 (19.6)
10.8 (21.8)
65.6 (37)
18.3 (30.8)
13.8 (27.5)
46.6 (37.2)
13.5 (29.2)
10.1 (23.7)
62.7 (31.3)
8.4 (17.4)
0.4
<0.05
<0.05
Numbers represent mean scores (standard deviation).
Advanced stages BC, clinical stages IIB–IIIC; BC, breast cancer; Early stages BC, clinical stages I–IIA; P, probability values; QLQ,
Quality of life questionnaire.
representing the patients’ perception of outcome. A better
understanding of HRQL may lead to enhanced care of
patients with cancer (Lancet editorial 1995).
Our study suggests that the Mexican-Spanish version of
the EORTC-BR23 module is clinically valid and reliable
for measuring HRQL and that it is suitable for use in
clinical studies including Mexican patients with BC. It is
noteworthy that we included a large sample of individuals
in this series. This datum is significant because it is the
first validation report of QLQ-BR23 in Mexico (Pan
American Health Organization-WHO (PAHO) 2006).
Low convergent validity and multi-item correlation for
cognitive scale (0.47) was observed in QLQ-C30. This
observation was reported in Mexican patients with gastric
cancer (Oñate-Ocaña et al. 2009), similar to Taiwanese
(Huang et al. 2007), Thai (Silpakit et al. 2006), English
(Sprangers et al. 1996) and Greek version of the EORTCQLQ-C30 (Kontodimopoulos et al. 2011). Nausea and
Vomiting showed low convergent validity (0.57), similar
to results found by the Polish study (Zawisza et al. 2010).
6
All other QLQ-C30 multi-item scales and all multi-item
scales of the QLQ-BR23 questionnaire presented a Cronbach’s a > 0.7, except for the Breast symptoms scale.
Health-related quality of life is a dynamic multidimensional measurement that changes over time and within
the same patient. As shown in the responsiveness scores
(Table 4), our patients exhibited various degrees of symptoms that improved after surgery. It is important to
mention the fact that our patients had high symptomatic
scores pre-operatively for QLQ-C30 and QLQ-BR23,
which is consistent with the high proportion of individuals treated with neo-adjuvant CT (61.9%), and preoperative chemoradiation (26.1%) due to poor clinical
response. Patients with locally advanced cancer had
higher scores than those with an early stage. As reported
by Montazeri et al. the majority of these symptoms demonstrated remarkable improvement shortly after surgery
(Montazeri et al. 2008).
We were unable to follow patients for a longer period of
time and to re-evaluate the variation of symptom-related
© 2012 Blackwell Publishing Ltd
Quality of life in patients with breast cancer
HRQL perception; however, several authors have shown
that patients with BC tend to report elevated levels of
fatigue, pain and dyspnoea, and arm symptoms in longterm follow-up as a result of cancer and its treatment,
similar to the results found in this series (Dorvall et al.
1998; Ganz et al. 2002; Montazeri et al. 2002; Mols et al.
2005).
Items related with body image, sexual functioning,
sexual enjoyment, and future perspective did not change
over time (Table 4). Although the measurements were
conducted within a short time, these observations do not
differ significantly from those of other reports, in which
significant deterioration over time has been observed for
sexual functioning and enjoyment (Ganz et al. 2002; Montazeri et al. 2002). Hormonal changes and menopausal
symptoms, such as hot flashes and vaginal dryness, are the
main causes of these problems (Mols et al. 2005).
During the translation and pilot testing of variables
related with sexual functioning, we encountered several
difficulties in the women interviewed. Questions regarding sexuality appeared to be embarrassing and the wording
of the phrases had to be rewritten twice for better understanding. The validation process showed that sexual
domain did not have equivalence (nor conceptual nor
semantic), but, in order to achieve comparability the
structure of sexually related items was not changed as
suggested by the EORTC translation group. These issues
reflect the importance of appropriate translation and
cross-culturally validated questionnaires when measuring
HRQL aspects that are influenced by ethnicity and perception of health and illness.
In countries such as Mexico, where patients with BC
have complex healthcare needs and where limited diagnostic and treatment resources exist, the introduction of
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