ArticlePDF Available

Prostate-specific symptoms of prostate cancer in a German general population

Authors:
  • Techniker Krankenkasse

Abstract and Figures

Predominant symptoms in prostate cancer patients are erectile dysfunctions and urinary problems. As decreases of these functions can be attributed to disease and treatment but also to age-related decreases, we conducted a study on a German reference population measuring general quality of life (QoL) as well as prostate-specific symptoms. In cooperation with a German health insurance company, 3000 questionnaires were mailed to a randomly selected sample of men aged 45-75 years. Questionnaires used were the EORTC QLQ-C30 and a prostate-specific module (PSM). One thousand one hundred and fifty questionnaires were returned (response rate: 37.6%). QoL data from this reference population were compared to QoL data from a historical cohort study of prostate cancer patients following either prostatectomy or radiotherapy. In terms of general QoL, the reference population showed similar QoL scores as prostatectomy patients, but better scores than radiotherapy patients. On the PSM, the reference sample showed better overall QoL, but a surprisingly high extent of erectile dysfunction, urinary problems and psychic strain. Taking into account the sensitive topic of this study (sexuality and urinary problems), the response rate is more than satisfying. Older men in our randomly selected, population-based sample do not show perfect erectile and urinary function. These findings should be considered when interpreting QoL data of prostate cancer patients.
Content may be subject to copyright.
ORIGINAL ARTICLE
Prostate-specific symptoms of prostate cancer in a German
general population
B Bestmann
1,3
, C Loetters
2
, T Diemer
2
, W Weidner
2
,TKu
¨
chler
1
and V Rohde
2,3
1
Department of General and Thoracic Surgery, Reference Center Quality of Life in Oncology, University Hospital of
Schleswig-Holstein, Kiel, Germany and
2
Department of Urology and Pediatric Urology, University Hospital, Giessen, Germany
Predominant symptoms in prostate cancer patients are erectile dysfunctions and urinary problems.
As decreases of these functions can be attributed to disease and treatment but also to age-related
decreases, we conducted a study on a German reference population measuring general quality of
life (QoL) as well as prostate-specific symptoms. In cooperation with a German health insurance
company, 3000 questionnaires were mailed to a randomly selected sample of men aged 45–75 years.
Questionnaires used were the EORTC QLQ-C30 and a prostate-specific module (PSM). One
thousand one hundred and fifty questionnaires were returned (response rate: 37.6%). QoL data
from this reference population were compared to QoL data from a historical cohort study of prostate
cancer patients following either prostatectomy or radiotherapy. In terms of general QoL, the
reference population showed similar QoL scores as prostatectomy patients, but better scores than
radiotherapy patients. On the PSM, the reference sample showed better overall QoL, but a
surprisingly high extent of erectile dysfunction, urinary problems and psychic strain. Taking into
account the sensitive topic of this study (sexuality and urinary problems), the response rate is more
than satisfying. Older men in our randomly selected, population-based sample do not show perfect
erectile and urinary function. These findings should be considered when interpreting QoL data of
prostate cancer patients.
Prostate Cancer and Prostatic Diseases (2007) 10, 52–59. doi:10.1038/sj.pcan.4500921; published online 14 November 2006
Keywords: healthy controls; prostate-specific symptoms; quality of life; reference population
Introduction
Prostate cancer is one of the most common forms of
cancer in males in Europe and in the USA. About 48 650
men in Germany are newly diagnosed with prostate
cancer every year.
1
As the two major treatment options
for patients with clinically localized prostate cancer (e.g.
radical prostatectomy and radiotherapy) are considered
to be comparable in terms of survival,
2
other therapy-
specific health outcomes such as quality of life (QoL)
may be important for treatment decisions. Furthermore,
the great majority of patients receiving treatment for
clinically localized prostate cancer ultimately die with,
rather than of, their carcinoma. Therefore, the patients
will have to live many years with the long-term effects of
their treatment,
3
which may have adverse impact on the
patients’ QoL.
At present, a great number of questionnaires have
been developed to measure general but also disease-
and/or treatment-specific QoL in patients with prostate
cancer. In Europe, the most commonly used instrument
for assessment of health-related QoL (HRQoL) in cancer
patients is the EORTC QLQ-C30.
4
It is designed to be
modular with the core questionnaire and additionally
disease- and/or treatment-specific modules to measure
disease-related symptoms or aspects of morbidity that
are consequences of the supplied therapy or tumor site.
Beginning in 1996, Kuechler and co-workers developed a
prostate-specific module (PSM) in a process similar to
the guidelines for the development of tumour- and
therapy-specific modules established by the EORTC
Study Group on QoL.
5
The prostate cancer module
consists of 36 items addressing therapy and prostate
cancer-specific issues such as change of sexual problems,
urinary problems or treatment strain leading to the scales
‘urinary problems’, ‘incontinence’, ‘erectile dysfunction’,
’sexual problems’, ‘problems with partner’, ‘pain’, ‘heat’,
‘nutrition’ and ‘psychic strain’.
6
Predominant symptoms in prostate cancer patients are
erectile dysfunction and urinary problems. Within
Europe and especially Germany, there is an ongoing
debate on what symptoms are prostate cancer associated
and what amount of symptoms is normal in men with
Received 22 June 2006; revised 19 September 2006; accepted 25
September 2006; published online 14 November 2006
Correspondence: Dr B Bestmann, Department of General and
Thoracic Surgery, Reference Center Quality of Life in Oncology,
University Hospital of Schleswig-Holstein, Kiel, Arnold-Heller-Str. 7,
Kiel 24105, Germany.
E-mail: bbestmann@chirurgie-sh.de
3
These authors contributed equally to this work.
Prostate Cancer and Prostatic Diseases (2007) 10, 5259
&
2007 Nature Publishing Group All rights reserved 1365-7852/07
$30.00
www.nature.com/pcan
increasing age. As decreases of these functions can be
attributed to disease and treatment but might also be age
related, we conducted a study on a German reference
population measuring as well general QoL as prostate-
specific symptoms using the EORTC QLQ-C30 and the
PSM. A few studies have been performed to obtain QoL
data from reference populations,
7
but this is the first trial
measuring disease-specific QoL in a German reference
population targeting prostate-specific QoL. The data
from this study can be used as comparison group in
studies with older men treated for prostate cancer.
Patients and methods
Subjects
A population-based sample of N ¼ 3000 men aged 45–75
years (selected according to prostate cancer incidence)
was randomly selected from the computer records of a
German general health insurance company (‘Sancura
BKK’). As we intended to investigate health-related QoL
in the general population, no medical inclusion or
exclusion criteria were defined. A letter of introduction
was mailed to all selected subjects from the health
insurance company. Two weeks later, each patient was
mailed the questionnaires together with a pre-stamped
return envelope. In order to provide a high level of
anonymity, the mailing was carried out by a neutral
private company. All patients who returned their
questionnaires within 4 weeks were included in the
analysis; a non-responder analysis was not possible due
to strict anonymization.
As a comparison group, five historic cohorts of
prostate cancer patients completing the same set of
questionnaires were used. This sample consists of
N ¼ 950 patients following either radical prostatectomy
or radiation therapy.
6
The patients following radio-
therapy were a little older than the prostatectomy
patients; furthermore, they tend to have higher tumor
stages. Therefore, in order to reduce this bias and to keep
the groups (radiotherapy vs prostatectomy) comparable,
the sample was restricted solely to a subsample of
N ¼ 375 patients with low or intermediate risk according
to international classification standards.
8
QoL assess-
ment was restricted up to 2 years after primary
treatment. Altogether, 39 patients following radiotherapy
and 436 patients following prostatectomy were included
in the statistical analysis.
Statistical analysis
The scoring of the EORTC QLQ-C30 core questionnaire
and the PSM was performed according to the EORTC
QLQ-C30 Scoring Manual:
5
scales were calculated when
at least half of the items were completed by the patients.
Internal consistency of the PSM was assessed by
calculating Cronbach’s alpha. Results are presented as
total numbers (%) or mean7s.d. All distribution and
frequencies were compared by w
2
test. QoL analyses were
performed parametrically using unpaired t-tests and
analyses of variance.
A P-value less than 0.05 was considered to be
statistically significant (corrected for multiple tests),
whereas a mean difference of 10 points and more on
the QoL scales represents a clinically significant/relevant
difference.
9
Instrumentation
HRQoL was assessed using the EORTC QLQ-C30 Core
Questionnaire (Version 2.0) and the PSM. The EORTC
QLQ-C30 is a cancer specific 30-item questionnaire.
4
It
includes five functional scales (physical, role, cognitive,
emotional and social), four symptom scales (fatigue,
pain, nausea and vomiting) and a global health scale.
There are also a number of single items addressing
additional symptoms commonly reported by cancer
patients (dyspnea, loss of appetite, insomnia, constipa-
tion and diarrhea) and perceived financial effect of the
disease. In the QLQ-C30, all items have response
categories with four levels, from ‘not at all’ to ‘very
much’, except the two items of the global health scale
(overall physical condition and for overall QoL), that use
seven-point items ranging from ‘very poor’ to ‘excellent’.
High scale scores present a high response level, with
high functional scale scores representing high/healthy
levels of functioning, and high scores for symptoms
scales/items representing high levels of symptomato-
logy/problems.
5
The PSM consists of 36 items addressing therapy and
prostate cancer-specific issues such as change of sexual
problems, urinary problems or treatment strain leading
to the theoretical scales ‘sexuality’, ‘pain’, ‘micturition’,
‘partnership’, ‘heat’, ‘general symptoms’ and ‘inconti-
nence’. The PSM was used in several (mainly historical
cohort) studies in Germany and has been psychometri-
cally tested using data from an empirical meta-analysis.
6
The PSM scales are scored according to the EORTC QLQ-
C30 symptom scales ranging from 0 to 100, with high
values representing a high level of symptomatology/
poor QoL.
Results
Sample description
The mailing was conducted from 1st of March until 15th
of April 2004. Within this time frame, 1150 out of the 3000
mailed questionnaires were returned by the patients
(response rate: 38.3%). Mean age of all respondents was
56.8 years (s.d. 7.7). Sociodemographic data are dis-
played in Table 1.
Even though the respondents in this sample are
somewhat younger than ‘the average prostate cancer
patient’, these data indicate that this sample of male
‘non-patients’ can be assumed to be comparable to
prostate cancer patients.
Psychometric properties of the PSM
As this disease-specific module was used the first time in
a ‘healthy’ population, the first step of analysis was an
evaluation of the module’s psychometric properties. The
PSM indicates good to sufficient internal consistency
with a total Cronbach’s alpha of 0.74. For the module
scales, Cronbach’s alpha ranges from 0.49 to 0.94.
Only the scales ‘(prostate-specific) pain’ and ‘nutrition’
show poor internal consistency (Cronbach’s alphao0.7);
Symptoms of prostate cancer in a German general population
B Bestmann et al
53
Prostate Cancer and Prostatic Diseases
similar findings for ‘nutrition’ and ‘(prostate-specific)
pain’ were shown in the validation study of the PSM.
6
These scales are currently revised by the authors (Table 2).
As the psychometric properties do not differ signi-
ficantly from the reliability coefficients reported in the
original validation study, we therefore assume the
module can be used for assessment of HRQoL in men
without prostate cancer too.
QoL data
The EORTC QLQ-C30 Functional Scales are shown in
Figure 1. Overall, subjects performed well on all
functional scales. Apart from ‘emotional functioning’,
all functional scales decrease with increasing age.
Especially on the scale ‘physical functioning’, a remark-
able age-related deterioration was found. Young patients
(aged 45–50 years) reported statistically and clinically
significant better QoL than older patients (aged 71–75
years), with a mean difference of at least 10 points on all
EORTC QLQ-C30 Functional Scales but ‘emotional
functioning’.
Figure 2 shows the EORTC QLQ-C30 Symptom Scales.
With increasing age, the symptom levels for ‘fatigue’,
‘pain’, ‘dyspnea’, ‘insomnia’ and ‘financial difficulties’
increase too. Especially men aged 71–75 years show
high levels of symptomatology. For ‘nausea/vomiting’,
‘appetite loss’ and ‘diarrhea’, no clear age-related trend
was found.
Figure 3 shows that similar to the findings for the
EORTC QLQ-C30 Symptom Scales, increasing age also is
associated with increasing levels of symptomatology
on the PSM Scales. On all PSM Scales, patients aged
71–75 years show a significantly poorer QoL than
younger patients. The mean values for ‘erectile dysfunc-
tion’, ‘sexual problems’ and ‘psychic strain’ increase
remarkably with increasing age.
Men aged 45–50 years and men aged 51–55 years show
similar erectile dysfunction scores. The mean difference
on the erectile dysfunction scales between young (aged
45–50) and old men (aged 71–75) is about 30 points,
which is not only statistically but also clinically of high
significance (Figure 4).
More than one-third of all respondents report some
degree of urinary dysfunction; 42.3% suffer from post-
void dribbling. Like on the other scales, all urinary
symptoms increase with increasing age, that is, younger
patients report better urinary function.
When compared to prostate cancer patients,
the healthy reference population shows similar
QoL scores as prostatectomy patients on the EORTC
QLQ-C30 Functional and Symptom Scales. Only on
the ‘social functioning’ scale the reference popu-
lation scored significantly better than prostatectomy
patients. Comparing the reference population to radio-
therapy patients, we found statistically and clinically
significant differences for ‘physical functioning’,
‘role functioning’, ‘social functioning’, ‘pain’ and
‘diarrhea’, with radiotherapy patients showing poorer
QoL (Figure 5).
Table 1 Sociodemographic characteristics of the sample
Reference sample (N ¼ 1150) Prostatectomy patients (N ¼ 436) Radiotherapy patients (N ¼ 39)
N (%) N (%) N (%)
Age categories (years)
45–50 347 (30.2) 7 (2.1) 1 (2.6)
51–55 236 (20.5) 38 (11.3) 0
56–60 179 (15.6) 61 (18.2) 4 (10.3)
61–65 201 (17.5) 90 (26.8) 3 (7.7)
66–70 140 (12.2) 109 (32.4) 15 (38.5)
71–75 31 (2.7) 31 (9.2) 16 (41.0)
Missing 16 (1.4) 0 0
Marital status
Unmarried 50 (4.4) 1 (0.3) 1 (2.6)
Married 956 (83.1) 262 (78.0) 32 (82.1)
Divorced 104 (9.0) 3 (0.9) 0
Widowed 26 (2.3) 8 (2.4) 4 (10.3)
Missing 14 (1.2) 62 (18.5) 2 (5.1)
Employment status
Full-time employed 648 (56.4) 59 (17.6) 3 (7.7)
Part-time employed 13 (1.1) 0 0
Housewife/-husband 2 (0.2) 0 0
Unemployed 125 (10.9) 6 (1.8) 1 (2.6)
Early retired 33 (2.9) 25 (7.4) 0
Retired 327 (28.4) 204 (60.7) 35 (89.7)
Missing 2 (0.2) 42 (12.5) 0
Table 2 Cronbach’s alpha for the PSM Scales
Cronbach’s alpha N Number of items
Erectile dysfunctions 0.761 858 2
Sexual problems 0.938 1060 5
Psychic strain 0.760 841 3
(Prostate-specific) pain 0.630 1004 5
Problems with partner 0.840 935 2
Nutrition 0.487 1140 2
Heat 0.770 1140 2
Urinary problems 0.706 1141 3
Mean 0.737 1015 3
Abbreviation: PSM, prostate-specific module.
Symptoms of prostate cancer in a German general population
B Bestmann et al
54
Prostate Cancer and Prostatic Diseases
On the PSM, we found similar QoL scores for
prostatectomy patients and the (healthy) reference
population in terms of ‘urinary problems’, ‘(prostate-
specific) pain’, ‘nutrition’ and ‘psychic strain’. Even
though the healthy reference population does not reach
the level of prostate cancer patients (prostatectomy as
well as radiotherapy patients), they show remarkably
high scores for ‘erectile dysfunction’ and ‘sexual
problems’ (Figure 6).
In summary, prostate cancer patients differ clinically
significant (Owing to the large sample size, almost all
differences are statistically significant, but certainly not
clinically relevant.) from the reference group of ‘non-
patients’ in four out of eight scales from the PSM.
As this study was designed to provide reference
values for QoL assessment in prostate cancer patients,
the mean scores and s.d. for all QoL scales are displayed
in Table 3.
Discussion
In this cross-sectional study, we have analyzed HRQoL
in a German reference population. The questionnaires
0
20
40
60
80
100
Physical functioning
(PF)
Role functioning
(RF)
Emotional
functionin
g
(EF)
Cognitive
functionin
g
(CF)
Social functioning
(SF)
Global Health
Status (QoL)
45 to 50 years
51 to 55 years
56 to 60 years
61 to 65 years
66 to 70 years
71 to 75 years
Figure 1 EORTC QLQ-C30 Functional Scales.
0
20
40
60
80
100
Fatigue (FA) Nausea/Vomiting
(NV)
Pain (PA ) Dyspnoea (DY) Insomnia (SL) Appetite loss (AP) Constipation (CO) Diarrhoea (DI) Financial difficulties
(FI)
45 to 50 years
51 to 55 years
56 to 60 years
61 to 65 years
66 to 70 years
71 to 75 years
Figure 2 EORTC QLQ-C30 Symptom Scales.
Symptoms of prostate cancer in a German general population
B Bestmann et al
55
Prostate Cancer and Prostatic Diseases
were mailed to a randomly selected sample of
N ¼ 3000 male insurants of a German health insurance
company.
Taking into account not only the sensitive topic but
also the facts that the questionnaire is comparatively long
and due to strict anonymization the use of incentives
was not possible, a response rate of 38.3% is really
satisfying. In a comparable study of older men without
prostate cancer in the USA, where cash incentives and
telephone reminders were used, a response rate of 44.8%
was achieved.
10
The questionnaires analyzed for this paper were the
EORTC QLQ-C30 core questionnaire
4
and a newly
validated PSM developed by Ku
¨
chler et al.
6
A psycho-
metric analysis of this healthy sample showed that the
PSM showed highly satisfactory internal consistency
with a mean Cronbach’s alpha of 0.73. We therefore
assume that this disease-specific instrument can be used
for the assessment of HRQoL in this German general
population.
In terms of general QoL (QLQ-C30), the reference
population showed similar QoL scores as prostatectomy
patients, but better scores than radiotherapy patients. On
the PSM, the reference sample showed better QoL, but a
high extent of erectile dysfunction, urinary problems and
psychic strain. Many studies compared HRQoL out-
comes after between treatments and at various times of
assessment. The findings of these studies are hetero-
geneous and many of them have methodological limita-
tions. One possible reason for the differences between
prostatectomy and radiotherapy patients in this study
could be that the radiotherapy patients are a generally
more ‘unhealthy’ subset of patients, that is, that patients
in a poorer general condition are more likely to receive
radiotherapy. Therefore, we tried to minimize this bias
by restricting the sample solely to patients with low to
intermediate risk.
Not only the EORTC QLQ-C30 functional and symp-
tom scales but also the scales from the PSM showed
significant dependencies on age. On all EORTC QLQ-C30
0
20
40
60
80
100
urinary
problems
erectile
dysfunction
sexual
problems
problems
with partner
(prostate
specific) pain
heat nutrition psychic
strain
45 to 50 years
51 to 55 years
56 to 60 years
61 to 65 years
66 to 70 years
71 to 75 years
Figure 3 PSM Scales.
99,0 02,06,
93,5
5,10,3
86,6 10,5 0,7
86,5 10,6 0,3
57,3 35,4 0,7
26,7 15,4 20,2 37,7
0% 20% 40% 60% 80% 100%
blood in urine or semen
pain while passing urine
urgency
hesitancy initiating
urination
post-void dribbling
dysuria
not at all a little quite a bit very much
Figure 4 Urinary problems of ‘non-patients’, all age groups.
Symptoms of prostate cancer in a German general population
B Bestmann et al
56
Prostate Cancer and Prostatic Diseases
Functional Scales, but ‘emotional functioning’ and
‘cognitive functioning’, a remarkable age-related de-
crease was found. For the EORTC QLQ-C30 Symptom
Scales, we found that increasing age is associated with
increasing levels of symptomatology. On the PSM scales,
it was shown that increasing age also corresponds with
higher levels of prostate-specific symptoms. For most
PSM scales, a linear relationship between age and scale
score was found. The increase of symptoms is most
pronounced in the oldest age group. Similar findings
were reported for the EORTC QLQ-C30 scales by
Hjermstad et al.
11
and Schwarz and Hinz.
7
This under-
lines the necessity to account for age differences when
populations with different age distributions are com-
pared. However, it should be kept in mind that these
data were obtained from a cross-sectional design and not
from a prospective sample. Another limitation of this
study is the respondents’ age. With a mean age of 57
years, this sample is clearly younger than the median age
at diagnosis of prostate cancer patients (B70 years). As
the participants of this study were randomly selected
from the records of a health insurance company, this fact
indicates a response bias (younger patients are more
likely to answer the questionnaires than older ones). It
would have been interesting to get more information
about this bias, but due to strict anonymization, a non-
0
20
40
60
80
100
Physical
Functioning
Role
Functioning
Emotional
Functioning
Cognitive
Functioning
Social
Functioning
Global
Health
Fatigue
Nausea/ Vomiting
Pain
Dyspnoea
Insomnia
Appetite Loss
Constipation
Diarrhoea
Financial
Difficulties
reference values radiation therapy
prostatectomy
EORTC QLQ-C30 Scales
Figure 5 Comparison between reference values and prostate cancer patients following either prostatectomy or radiotherapy.
0
10
20
30
40
50
60
70
80
90
100
Erectile
Dysfunctions
Sexual Problems Psychic Strain Pain Problems with
Partner
Nutrition Heat Urinary Problems
healthy controls
radio therapy prostatectomy
Figure 6 Comparison between reference values and prostate cancer patients following either prostatectomy or radiotherapy.
Symptoms of prostate cancer in a German general population
B Bestmann et al
57
Prostate Cancer and Prostatic Diseases
responder analysis was not feasible. Nevertheless, as the
data of this study is not analyzed and presented as a
whole, but in a age-stratified way, this reference data
allow future comparisons with different samples of
prostate cancer patients obtained from clinical studies.
Comparing the reference sample to the historic cohort
of prostate cancer patients on the EORTC QLQ-C30
scales, it was shown that the healthy sample showed
similar QoL scores as prostatectomy patients, but
significantly better QoL than radiotherapy patients on
the PSM; the reference sample showed better QoL than
prostate cancer patients (prostatectomy patients as well
as radiotherapy patients), but also a remarkably high
degree of ‘erectile dysfunction’ and ‘sexual problems’.
Interpreting these differences, it has to be kept in mind
that the reference population studied in this paper is no
completely healthy but rather a ‘normal’ sample. Patients
with a history of prostate or other sites of cancer were not
excluded from this survey. We assume that the incidence
rate for prostate cancer in this randomly selected sample
is comparable to the incidence rate in Germany in
general.
Conclusions
Comparisons with reference populations facilitate to
interpret the significance of differences in QoL scores of
different patient groups (e.g. patients with high and low
tumor stage) and score changes over time.
The male ‘non-patients’ in our randomly selected,
population-based sample do not show perfect erectile
and urinary function. The data showed decreases in
sexual functions not only for prostate cancer patients but
also to some extent for the age-matched reference
population. The increase of symptoms and decreases of
sexual and urinary function in prostate cancer patients
should therefore not only be attributed to radical
treatment for prostate cancer but also to the normal
aging process as well. These findings should be kept in
mind when interpreting QoL data of prostate cancer
patients.
Acknowledgements
This study was supported by grants from Takeda
Pharma Inc. (Japan) and Sancura BKK (Germany).
References
1 Arbeitsgemeinschaft Bevo
¨
lkerungsbezogener Krebsregister in
Zusammenarbeit mit dem Robert-Koch-Institut (Hrg.): Krebs in
Deutschland- Ha
¨
ufigkeiten und Trends. 4. u
¨
berarbeitete, aktua-
lisierte Ausgabe, Saarbru
¨
cken, 2004.
2 Middleton RG, Thompson IM, Austenfeld MS, Cooner WH,
Correa RJ, Gibbons RP et al. Prostate cancer clinical guidelines
panel summary report on the management of clinically localized
prostate cancer. The American Urological Association. JUrol
1995; 154: 2144–2148.
3 Potosky AL, Legler J, Albertsen PC, Stanford JL, Gilliland FD,
Hamilton AS et al. Health outcomes after prostatectomy or
radiotherapy for prostate cancer: results from the prostate cancer
outcomes study. J Natl Cancer Inst 2000; 92: 1582–1592.
4 Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A,
Duez NJ et al. The European Organization for Research and
Treatment of Cancer QLQ-C30: a quality-of-life instrument for
use in international clinical trials in oncology. J Natl Cancer Inst
1993; 85: 365–376.
Table 3 Mean scores and s.d. for all QoL scales (EORTC QLQ-C30 Functional and Symptom Scales, scales of the PSM)
All respondents 45–50 years 51–55 years 56–60 years 61–65 years 66–70 years 71–75 years Age not specified
N ¼ 1150 N ¼ 347 N ¼ 236 N ¼ 179 N ¼ 201 N ¼ 140 N ¼ 31 N ¼ 16
PF 90.0 (15.2) 93.8 (11.3) 92.2 (14.2) 89.1 (14.4) 87.4 (16.1) 85.79 (18.8) 76.9 (21.0) 78.2 (21.9)
RF 87.7 (22.0) 92.7 (17.4) 90.0 (20.5) 84.0 (24.6) 84.9 (22.8) 83.2 (25.2) 78.5 (26.2) 74.2 (25.1)
EF 73.6 (23.1) 73.6 (22.7) 71.0 (24.3) 72.9 (22.6) 74.8 (23.0) 78.7 (22.5) 73.1 (23.4) 63.3 (22.2)
CF 83.2 (20.1) 86.4 (18.1) 84.0 (20.4) 82.0 (21.6) 81.5 (19.9) 82.4 (18.5) 66.7 (27.2) 72.2 (23.3)
SF 85.5 (23.5) 89.7 (19.3) 86.0 (22.2) 84.9 (26.1) 82.0 (25.2) 83.1 (25.6) 72.0 (29.6) 81.1 (21.7)
Global health status (QoL) 69.0 (19.5) 72.0 (18.3) 69.6 (19.2) 67.7 (19.7) 66.3 (20.0) 68.5 (20.5) 62.4 (21.0) 61.1 (18.8)
FA 21.5 (22.6) 17.9 (21.4) 20.7 (23.0) 22.5 (21.5) 23.6 (22.6) 22.5 (22.4) 37.1 (28.2) 36.4 (28.1)
NV 2.2 (8.6) 2.0 (7.6) 3.0 (10.4) 2.3 (10.6) 2.1 (6.4) 1.8 (8.6) 0.5 (3.0) 3.0 (6.7)
PA 23.1 (28.2) 17.0 (24.2) 22.4 (27.2) 28.2 (32.7) 24.7 (28.4) 24.9 (26.7) 33.3 (31.9) 55.6 (31.3)
DY 11.5 (22.7) 6.7 (18.3) 8.8 (20.0) 15.6 (22.8) 13.9 (25.4) 15.6 (25.8) 22.2 (29.5) 33.3 (36.5)
SL 22.4 (28.2) 16.3 (24.3) 21.2 (29.8) 23.1 (27.8) 26.2 (27.9) 29.1 (30.4) 33.3 (34.4) 46.7 (32.2)
AP 3.9 (12.9) 2.5 (9.5) 5.2 (15.6) 5.1 (14.0) 4.5 (13.6) 2.6 (12.0) 3.2 (10.0) 9.1 (21.6)
CO 4.4 (14.1) 3.1 (12.6) 3.1 (12.3) 4.1 (13.6) 5.7 (14.3) 6.0 (17.1) 9.7 (21.4) 13.3 (21.3)
DI 8.1 (18.1) 6.3 (15.4) 8.6 (20.1) 10.1 (19.0) 7.8 (16.4) 8.7 (19.6) 9.7 (19.6) 17.8 (27.8)
FI 16.3 (28.8) 8.7 (21.5) 14.3 (29.2) 18.6 (28.7) 21.2 (30.8) 20.5 (31.1) 34.4 (37.0) 48.9 (39.6)
Urinary problems 1.8 (7.4) 0.8 (5.5) 1.0 (4.6) 1.5 (5.2) 2.7 (8.6) 2.9 (9.6) 8.8 (19.1) 5.2 (10.2)
Erectile dysfunction 51.1 (29.2) 42.7 (25.9) 42.9 (25.1) 53.2 (29.9) 60.0 (29.4) 66.2 (31.0) 72.2 (29.6) 48.7 (26.8)
Sexual problems 26.9 (29.3) 14.3 (20.8) 20.6 (25.4) 28.1 (28.0) 40.6 (31.9) 45.1 (32.4) 47.2 (34.2) 23.2 (22.3)
Problems with partner 9.5 (20.0) 6.0 (15.9) 7.1 (16.7) 11.8 (23.7) 13.0 (21.0) 11.9 (23.6) 14.7 (27.4) 12.8 (18.2)
(Prostate-specific) pain 16.2 (19.9) 12.1 (16.2) 15.9 (19.8) 20.7 (24.1) 16.8 (20.3) 17.3 (19.6) 23.7 (18.1) 28.9 (25.1)
Heat 7.5 (17.3) 5.1 (12.1) 9.0 (19.9) 9.8 (19.4) 8.2 (18.4) 5.1 (15.1) 11.3 (23.3) 18.9 (25.1)
Nutrition 8.2 (16.1) 5.8 (11.8) 9.5 (19.4) 8.4 (15.8) 7.5 (14.7) 9.5 (18.0) 19.9 (20.8) 15.6 (21.3)
Psychic strain 25.4 (22.3) 20.1 (19.7) 24.3 (22.4) 27.6 (23.8) 28.5 (21.7) 29.4 (22.8) 37.7 (26.6) 38.0 (26.2)
Abbreviations: AP, appetite loss; CF, cognitive functioning; CO, constipation; DI, diarrhea; DY, dyspnea; EF, emotional functioning; FA, fatigue; FI, financial
difficulties; NV, nausea/vomiting; PA, pain; PF, physical functioning; PSM, prostate-specific module; QoL, quality of life; RF, role functioning; SF, social
functioning; SL, insomnia.
Symptoms of prostate cancer in a German general population
B Bestmann et al
58
Prostate Cancer and Prostatic Diseases
5 Fayers P, Aaronson N, Bjordal K, Curran D, Groenvold M, on
behalf of the EORTC Quality of Life Study Group. Guidelines for
Developing Questionnaire Modules. Quality of Life Study Group:
Brussels, 1999.
6 Bestmann B, Rohde V, Siebmann JU, Galalae R, Weidner W,
Ku
¨
chler T. Validation of the German prostate specific module
(PSM). World J Urol 2006; 19: 1–7.
7 Schwarz R, Hinz A. Reference data for the quality of life
questionnaire EORTC-QLQ-C-30 in general German population.
Eur J Cancer 2001; 37: 1345–1351.
8 D’Amico AV, Whittington R, Malkowicz SB, Weinstein M,
Tomaszewski JE, Schultz D et al. Predicting prostate specific
antigen outcome preoperatively in the prostate specific antigen
era. JUrol2001; 166: 2185–2188.
9 Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the
significance of changes in health-related quality-of-life scores. J
Clin Oncol 1998; 16: 139–144.
10 Litwin MS. Health related quality of life in older men without
prostate cancer. JUrol1999; 161: 1180–1184.
11 Hjermstad MJ, Fayers PM, Bjordal K, Kaasa S. Health-related
quality of life in the general Norwegian population assessed by
the European Organization for Research and Treatment of
Cancer Core Quality-of-Life Questionnaire: the QLQ ¼ C30
(+3). J Clin Oncol 1998; 16: 1188–1196.
Symptoms of prostate cancer in a German general population
B Bestmann et al
59
Prostate Cancer and Prostatic Diseases
... It is interesting that most detriments in HRQoL of PC survivors when compared to controls were found in social functioning. This result is comparable findings of to two other studies [29,30]. An explanation for this finding might be that long-term PC survivors continue to suffer from urological problems like urinary incontinence/ urinary bother as our study showed. ...
Article
Full-text available
Background Prostate cancer (PC) and its treatment may affect PC survivors differently with respect to age. However, little is known regarding age-specific health-related quality of life (HRQoL) in PC survivors 5 years or even ≥ 10 years post-diagnosis. Methods The sample included 1975 disease-free PC survivors (5–16 years post-diagnosis) and 661 cancer-free population controls, recruited from two German population-based studies (CAESAR+, LinDe). HRQoL in both populations was assessed using the EORTC QLQ-C30 questionnaire. Additionally, PC survivors completed the PC-specific EORTC QLQ-PR25 questionnaire. Differences in HRQoL between survivors and controls, as well as differences according to age and time since diagnosis were analyzed with multiple regression after adjustment for age, education, stage, and time since diagnosis, where appropriate. Results In general, PC survivors reported HRQoL and symptom-burden levels comparable to the general population, except for significantly poorer social functioning and higher burden for diarrhea and constipation. In age-specific analyses, PC survivors up to 69 years indicated poorer global health and social functioning than population controls. Stratification by time since diagnosis revealed little difference between the subgroups. On PC-specific symptoms, burden was highest for urinary bother and symptoms, and lowest for bowel symptoms. Younger age was associated with less urinary symptoms but higher urinary bother. Conclusion Long-term disease-free PC survivors reported overall good HRQoL, but experienced persistent specific detriments. Our data suggest that these detriments do not improve substantially with increasing time since diagnosis. Targeted interventions are recommended to prevent PC-related and treatment-related symptoms becoming chronic and to enhance social functioning.
... Interestingly, the overall QOL score of the PC patients was similar to that of the general population at baseline and postoperative 3 months, and became even slightly higher at postoperative 12 months, although this increase was not clinically significant. This finding was consistent with cross-sectional studies from Germany [27,28] in which the global QOL of PC patients was found to be comparable to that of the general population. As in previous studies [29,30], our results indicate that PC survivors have the capacity to positively adapt to the challenges of cancer diagnosis and treatment and that their experience of cancer survival may contribute to a more positive perception of QOL. ...
Article
Full-text available
Purpose: Health-related quality of life (HRQOL) information related to radical prostatectomy (RP) is valuable for prostate cancer (PC) patients needing to make treatment decisions. We aimed to investigate HRQOL change in PC patients who underwent three types of RP (open, laparoscopic, or robotic) and compared their HRQOL with that of general population. Materials and methods: Patients were prospectively recruited between October 2014 and December 2015. EORTC QLQ-C30 and PC-specific module (PR25) were administered before surgery (baseline) and at postoperative 3 and 12 months. At each time point, HRQOL was compared, and a difference of 10 out of 0-100 scale was considered clinically significant. Results: Among 258 screened patients, 209 (41 open, 63 laparoscopic, and 105 robotic surgeries) were included. Compared to baseline, physical, emotional, and cognitive functioning improved at 12 months. Role functioning worsened at 3 months, but recovered to baseline at 12 months. Pain, insomnia, diarrhea, and financial difficulties also significantly improved at 12 months. Most PR25 scales excluding bowel symptoms deteriorated at 3 months. Urinary symptoms and incontinence aid recovered at 12 months, whereas sexual activity and sexual function remained poor at 12 months. Clinically meaningful differences in HRQOL were not observed according to RP modalities. Compared to the general population, physical and role functioning were significantly lower at 3 months, but recovered by 12 months. Social functioning did not recover. Conclusion: Most HRQOL domains showed recovery within 12 months after RP, excluding sexual functioning and social functioning. Our findings may guide patients considering surgical treatment for PC.
... Compared to non-cancer controls, PC survivors showed lower social functioning (Table 4), which seemed to worsen >2 years post surgery (Fig. 1). A German study has reported that social functioning among PC survivors who underwent RP was significantly lower than that observed in the general population, whereas other EORTC QLQ-C30 scales were similar to those observed in controls-a finding that is in agreement with that observed in our study [17]. Although urinary incontinence improves gradually over time after RP and recovers to baseline status approximately at 1-year postsurgery in most PC survivors, a few Korean Cancer Association This article is protected by copyright. ...
Article
Full-text available
Purpose: The purpose of this study was to compare health-related quality of life (HRQoL) of disease-free prostate (PC), kidney (KC), and bladder cancer (BC) survivors with that of the general population. Materials and methods: Our study included 331 urological cancer (UC) survivors (114 PC, 108 KC, and 109 BC) aged ≥ 50 years disease-free for at least 1 year after surgery. The control group included 1,177 subjects without a history of cancer. The HRQoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30, the Duke-UNC Functional Social Support Questionnaire, and the Patient Health Questionnaire-9. Results: There was no significant difference between the groups in terms of any of the functioning sub-scales and symptoms, except significantly lower social functioning observed in BC survivors than that observed in KC survivors. Although the three groups of UC survivors showed essentially similar functioning sub-scales and symptoms when compared to the general population, PC and BC survivors showed significantly lower social functioning and a lower appetite than that observed in controls. KC survivors showed lower physical functioning, as well as higher pain and dyspnea. Although all three groups of UC survivors reported higher financial difficulties, they also reported higher perceived social support than that reported by the non-cancer control group. No statistically significant difference was observed in terms of depressive symptoms between each group of UC survivors and the general population. Conclusion: Disease-free survivors of the three major types of UCs showed generally similar HRQoL compared to the general population, as well as compared to each other.
... Prostate cancer is the most common malignancy in men in the developed world [1]. In Germany, the annual incidence is estimated to be as high as 48,650 new cases, accounting for approximately 22% of all cancer in males [2]. ...
Article
Full-text available
We are reporting the five-year biochemical control, toxicity profile and dosimetric parameters using iodine-125 low dose rate brachytherapy (BT) as monotherapy for early stage prostate cancer at a single institution. Between April 2006 and December 2010, 169 men with early stage prostate cancer were treated with BT. Biochemical failure was defined using the Phoenix definition (nadir + 2 ng/mL). Treatment-related morbidities, including urinary, rectal and sexual function, were measured, applying the International Prostate Symptom Score (IPSS), the 7-grade Quality of Life Scale (QoL) and medical status, the International Consultation on Incontinence Modular Questionnaire (ICIQ), the International Index of Erectile Function (IIEF-5) and the Common Terminology Criteria for Adverse Events (CTCAE v4.03). Seed migration and loss, dosimetric parameters and learning effects were also analyzed. Medium follow-up time was 50 months (range, 1-85 months). The five-year biochemical failure rate was 7%. Acute proctitis rates were 19% (grade 1) and 1% (grade 2), respectively. The overall incidence of incontinence was 19% (mild), 16% (moderate) and < 1% (severe). An increase in IPSS ≥ 5 points was detected in 59% of patients, with 38% regaining their baseline. Seed dislocation was found in 24% of patients and correlated with D90 and V100. A learning curve was found for seed migration, D90 and V100. QoL correlated with the general health condition of patient, incontinence symptoms and IPSS. BT for early stage prostate cancer offers excellent five-year biochemical control with low toxicities. QoL aspects are favorable. A learning curve was detected for procedural aspects but its impact on patient relevant endpoints remains inconclusive.
... Der Fragebogen wurde speziell für onkologische Patienten entwickelt und erfragt u. a. Symptome, Funktionen und allgemeines Wohlbefinden. Ergänzend wurden zur Bewertung der krankheitsspezifischen gLQ die deutsche Fassung des prostataspezifischen Moduls (PSM) verwendet [4] . Die Auswertung erfolgte entsprechend den Auswertungsvorschriften der EORTC [9]. ...
Article
Full-text available
Background: Prostate cancer (PCA) is the most common form of neoplasm in men and various treatment options are available. Knowledge of health-related quality of life (HRQL) can provide information to support informed decision-making. In addition, information on factors influencing HRQL can provide indications for the further development of medical treatment. The aim of the study was to obtain data on HRQL after inpatient treatment of PCA and the identification of determinants of HRQL after PCA in routine healthcare. Materials and methods: In this study a total of 1165 beneficiaries of a German health insurance with a hospital stay due to prostate cancer (ICD C61) were surveyed on their health-related quality of life using the European Organization for Research and Treatment of Cancer quality of life questionnaire version 3 (EORTC QLQ-C30 V3.0) and disease-specific symptoms using the perceived sensitivity to medicine (PSM) scale 14 months after discharge. Survey data were linked with pseudonymous claims data of the health insurance provider. Determinants of HRQL were examined by logistic regression. Results: Responses from 825 men (mean age 67.6 years and 80% treated with radical prostatectomy) were available for analysis (response 70.8%). Compared to the reference population impairments in HRQL were reported especially in terms of the roles and social functionality. The prostate-specific symptoms varied depending on the treatment strategy. A nerve-sparing surgical technique reduced the likelihood of erectile dysfunction. Other protective factors were no pre-existing comorbidities and younger age. Discussion: The effects of PCA on the HRQOL varied by age, comorbidities and treatment modality which should be considered in healthcare information and counseling of patients.
... Direct conclusions about the effect of the partner's own social support are therefore limited. The EORTC items constipation and diarrhea, and the EORTC fatigue scale, the urinary urge syndrome scale of the Prostate Specific Module (PSM) [29], and the erectile dysfunction scale of the International Index of Erectile Function (IIEF) [30] were included into the model as cancer related factors. Appraisal of the situation was measured by anxiety/depression in the partner (item of the European Quality of Life-5 Dimensions, EQ-5D) [31] and by confidence in health in the patients (PSM item on psychological strain symptoms). ...
Article
The diagnosis of prostate cancer and the following treatment does not only affect the patient, but also his partner. Partners often suffer even more severely from psychological distress than the patients themselves. This analysis aims to describe the quality of life (QoL) after the cancer diagnosis over time and to identify the effects of possible predictors of partners' quality of life in a German study population. Patients with localised prostate cancer and their partners were recruited from a prospective multicenter study in Germany, the Prostate Cancer, Sexuality, and Partnership (ProCaSP) Study. At five observation times during the follow-up period of 2 years after diagnosis, QoL (EORTC QLQ-C30) and personal, social, and cancer-related health factors as well as adaptation and coping factors of 293 couples were observed and analysed with mixed effects analysis. The men's prostate cancer diagnosis had a small, but significant impact on their partner's QoL. However, QoL of partners was most affected by the partners' own physical health and psychological condition, time, and their relationship quality. The finding that average QoL increased again 3 months after diagnosis and later should give partners faith and hope for the future. The identified most important predictors of partners' QoL are potentially susceptible to intervention, and further research on target groups in special need of support and on adequate interventions is needed.
Article
Full-text available
Men with prostate cancer experience many side effects and symptoms that may be improved by a physically active lifestyle. It was hypothesized that older men with prostate cancer who were physically active would report significantly higher levels of quality of life (QOL) as assessed by the WHOQOL-BREF and the WHOQOL-OLD. Of the 348 prostate cancer survivors who were invited to participate in the present postal survey, 137 men returned the questionnaires. Those who were physically active had significantly lower prostate specific antigen (PSA) scores and higher social participation than those insufficiently active. These findings offer some support for the benefits of physical activity (PA) within the prostate cancer population in managing the adverse side effects of their treatments on aspects of their QOL. Future research should more closely examine what types of PA best promote improvements in varying aspects of QOL and psychological well-being for prostate cancer survivors.
Article
Introduction: In German-speaking countries only one validated questionnaire asking for prostate-specific quality of life existed until summer 2009 (PSM; but since then the German version of EORTC QLQ-PR25 was available). After a translation of the English version of PORPUS into German we wanted to show psychometric properties of the translated questionnaire. Materials and Methods: Sensitivity to change and validity were proven with data from the San-BKK- (general population, one questioning), the CHEDY- (men with erectile dysfunction, one questioning) and the ProCaSP-study (men with localized prostate cancer [PCa]), initial questioning and 4 follow-up surveys within 2 years). Each study focused on quality of life as a primary endpoint. Quality of life was measured with multiple questionnaires, e. g. EORTC QLQC30, EQ-5D, and PORPUS-P. Results: Data were derived from 988 men of the general population (mean age 56 years), 87 PCa-patients with radiotherapy (67 years), 274 PCa-patients with radical prostate ectomy (63 years), and 48 men with erectile dysfunction (58 years). Different quality of life-scales correlated with each other and proved convergence validity (PORPUS-P vs. EORTC QLQ-C30 global health, EQ-5D VAS and EQ-5D index value; range rs = 0.518-0.630; each p < 0.001). Furthermore, PORPUS-P differed between age groups, health status, and social subgroups. The distribution of answers in the general population indicated sensitivity to change as well as the changes of answering patterns and changes of PORPUS-P in men with PCa (follow up for 2 years). Approximately 3.5 minutes are needed to complete PORPUS (10 items). Conclusion: PORPUS is another valid German questionnaire to evaluate prostate-specific quality of life. The advantage of PORPUS is its briefness, which allows a good acceptance and fits in busy clinical routines.
Article
Full-text available
In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included. The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity. The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient > or = .70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe. These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.
Article
Full-text available
To determine the significance to patients of changes in health-related quality-of-life (HLQ) scores assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). A subjective significance questionnaire (SSQ), which asks patients about perceived changes in physical, emotional, and social functioning and in global quality of life (global QL) and the QLQ-C30 were completed by patients who received chemotherapy for either breast cancer or small-cell lung cancer (SCLC). In the SSQ, patients rated their perception of change since the last time they completed the QLQ-C30 using a 7-category scale that ranged from "much worse" through "no change" to "much better." For each category of change in the SSQ, the corresponding differences were calculated in QLQ-C30 mean scores and effect sizes were determined. For patients who indicated "no change" in the SSQ, the mean change in scores in the corresponding QLQ-C30 domains was not significantly different from 0. For patients who indicated "a little" change either for better or for worse, the mean change in scores was about 5 to 10; for "moderate" change, about 10 to 20; and for "very much" change, greater than 20. Effect sizes increased in concordance with increasing changes in SSQ ratings and QLQ-C30 scores. The significance of changes in QLQ-C30 scores can be interpreted in terms of small, moderate, or large changes in quality of life as reported by patients in the SSQ. The magnitude of these changes also can be used to calculate the sample sizes required to detect a specified change in clinical trials.
Article
PurposeThe American Urological Association convened the Prostate Cancer Clinical Guidelines Panel to analyze the literature regarding available methods for treating locally confined prostate cancer, and to make practice policy recommendations based on the treatment outcomes data insofar as the data permit.Materials and MethodsThe panel searched the MEDLINE data base for all articles from 1966 to 1993 on stage T2 (B) prostate cancer and systematically analyzed outcomes data for radical prostatectomy, radiation therapy and surveillance as treatment alternatives. Outcomes considered most important were survival at 5, 10 and 15 years, progression at 5, 10 and 15 years, and treatment complications.ResultsThe panel found the outcomes data inadequate for valid comparisons of treatments. Differences were too great among treatment series with regard to such significant characteristics as age, tumor grade and pelvic lymph node status. The panel elected to display, in tabular form and graphically, the ranges in outcomes data reported for each treatment alternative.ConclusionsIn making its recommendations, the panel presented treatment alternatives as options, identifying the advantages and disadvantages of each, and recommended as a standard that patients with newly diagnosed, clinically localized prostate cancer should be informed of all commonly accepted treatment options.
Article
To obtain reference data on health-related quality of life (HRQOL) for the functional and symptom scales and single items of the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ-C30 [+ 3]) in a representative sample of the Norwegian general population. A randomly selected sample of 3,000 people from the Norwegian population, aged 18 to 93 years, who represent geographic diversity, took part in this postal survey. The EORTC QLQ-C30 (+ 3) and a questionnaire about demographic data and health were sent by mail. A new questionnaire package was sent as a reminder after 3 weeks. The survey yielded a high response rate with 1,965 of 2,892 eligible persons responding (68%). There was a low amount of missing data (1.8%). Internal consistency was highly satisfactory and yielded Cronbach's alpha coefficients greater than 0.70 for all but two functional scales and one symptom scale. The sensitivity of the questionnaire was shown by the excellent discrimination between age and sex groups. Clinical validity was shown by the distinct differences according to age and sociodemographic characteristics. Women reported lower functional status and global quality of life (mean scale scores from 71.7 to 91.0) than men (mean scale scores from 75.4 to 94.4), and also more symptoms and problems. This was remarkably consistent across age groups, as was a decline in functional status with an increase in age. This is the first study that presented reference data from the EORTC QLQ-C30 (+ 3) in a sample from a general population and seems to provide valid measures of HRQOL within different age groups. The results may serve as a guideline for clinicians when interpreting HRQOL in their own groups of patients, and contributes to a better understanding of the significance of mean scores and their clinical relevance.
Article
The American Urological Association convened the Prostate Cancer Clinical Guidelines Panel to analyze the literature regarding available methods for treating locally confined prostate cancer, and to make practice policy recommendations based on the treatment outcomes data insofar as the data permit. The panel searched the MEDLINE data base for all articles from 1966 to 1993 on stage T2 (B) prostate cancer and systematically analyzed outcomes data for radical prostatectomy, radiation therapy and surveillance as treatment alternatives. Outcomes considered most important were survival at 5, 10 and 15 years, progression at 5, 10 and 15 years, and treatment complications. The panel found the outcomes data inadequate for valid comparisons of treatments. Differences were too great among treatment series with regard to such significant characteristics as age, tumor grade and pelvic lymph node status. The panel elected to display, in tabular form and graphically, the ranges in outcomes data reported for each treatment alternative. In making its recommendations, the panel presented treatment alternatives as options, identifying the advantages and disadvantages of each, and recommended as a standard that patients with newly diagnosed, clinically localized prostate cancer should be informed of all commonly accepted treatment options.
Article
We measured health related quality of life in a population of normal older men for use as controls in studies of older men treated for prostate cancer. A statistically valid, population based sample of older men without prostate cancer completed a validated quality of life questionnaire that addressed impairment in the physical, mental, urinary, bowel and sexual domains. General and disease targeted health related quality of life was measured by the RAND 36-Item Health Survey and University of California, Los Angeles Prostate Cancer Index, respectively. Overall approximately a third of normal older men reported some degree of urinary leakage, while a third claimed some degree of rectal dysfunction and almost two-thirds acknowledged significant difficulty with erection. Older men in a randomly selected, population based sample do not have perfectly normal urinary continence, bowel function or sexual potency. By collecting data before treatment and following subjects longitudinally investigators may ensure that health related quality of life changes are analyzed in the context of any impairment that may have been present at baseline. If a longitudinal study is not feasible, a control group of men who are similar in age and other demographic variables must be used.
Article
Radical prostatectomy and external beam radiotherapy are the two major therapeutic options for treating clinically localized prostate cancer. Because survival is often favorable regardless of therapy, treatment decisions may depend on other therapy-specific health outcomes. In this study, we compared the effects of two treatments on urinary, bowel, and sexual functions and on general health-related quality-of-life outcomes over a 2-year period following initial treatment. A diverse cohort of patients aged 55-74 years who were newly diagnosed with clinically localized prostate cancer and received either radical prostatectomy (n = 1156) or external beam radiotherapy (n = 435) were included in this study. A propensity score was used to balance the two treatment groups because they differed in some baseline characteristics. This score was used in multivariable cross-sectional and longitudinal regression analyses comparing the treatment groups. All statistical tests were two-sided. Almost 2 years after treatment, men receiving radical prostatectomy were more likely than men receiving radiotherapy to be incontinent (9.6% versus 3.5%; P:<.001) and to have higher rates of impotence (79.6% versus 61.5%; P:<.001), although large, statistically significant declines in sexual function were observed in both treatment groups. In contrast, men receiving radiotherapy reported greater declines in bowel function than did men receiving radical prostatectomy. All of these differences remained after adjustments for propensity score. The treatment groups were similar in terms of general health-related quality of life. There are important differences in urinary, bowel, and sexual functions over 2 years after different treatments for clinically localized prostate cancer. In contrast to previous reports, these outcome differences reflect treatment delivered to a heterogeneous group of patients in diverse health care settings. These results provide comprehensive and representative information about long-term treatment complications to help guide and inform patients and clinicians about prostate cancer treatment decisions.
Article
The objective of this study was to obtain age- and sex-specific reference values for the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30. A randomly selected sample of the German adult population (3015 subjects) was used, 2081 subjects agreed to take part in the investigation. Most of the scales and symptom items of the questionnaire proved to be dependent on age and sex. Men reported fewer symptoms than women. Age differences were even more pronounced. Younger people reported better functioning and fewer symptoms. Compared with the results of a similar Norwegian study (Hjermstad MJ, Fayers PM, Bjordal K, Kaasa S. Health related quality of life in the general Norwegian population assessed by the European Organization for research and treatment of cancer core quality-of-life questionnaire: The QLQ-C30(+3). J Clin Oncol 1998, 16, 1188-1196) the prevalence of some symptoms was markedly less. Norm values for age and sex groups are given and regression analyses are performed which help to calculate expected mean scores. The results show that age and sex differences must be taken into consideration when different groups of cancer patients are compared. The norm values help to interpret quality of life data for clinicians.
Article
We evaluated the ability of previously defined risk groups to predict prostate specific antigen (PSA) outcome 10 years after radical prostatectomy in patients diagnosed with clinically localized prostate cancer during the PSA era. Between 1989 and 2000, 2,127 men with clinically localized prostate cancer underwent radical prostatectomy, including 1,027 at Hospital of the University of Pennsylvania (study cohort) and 1,100 at Brigham and Women's Hospital (validation cohort). Cox regression analysis was done to calculate the relative risk of PSA failure with the 95% confidence interval (CI) in patients at intermediate and high versus low risk. The Kaplan-Meier actuarial method was used to estimate PSA outcome 10 years after radical prostatectomy. Compared with low risk patients (stages T1c to 2a disease, PSA 10 ng./ml. or less and Gleason score 6 or less) the relative risk of PSA failure in those at intermediate (stage T2b disease or PSA greater than 10 to 20 ng./ml. or less, or Gleason score 7) and high (stage T2c disease, or PSA greater than 20 ng./ml. or Gleason score 8 or greater) risk was 3.8 (95% CI 2.6 to 5.7) and 9.6 (95% CI 6.6 to 13.9) in the study cohort, and 3.3 (95% CI 2.3 to 4.8) and 6.3 (95% CI 4.3 to 9.4) in the validation cohort. The 10-year PSA failure-free survival rate in the 1,020 patients in the low, 693 in the intermediate and 414 in the high risk groups was 83%, 46% and 29%, respectively (p <0.0001). Based on 10-year actuarial estimates of PSA outcome after radical prostatectomy 3 groups of patients were identified using preoperative PSA, biopsy Gleason score and 1992 clinical T category.