Appendix 6 Evidence tables
Clinical question 1 Can the relevant cancer or applied treatment lead to somatic, psychological and/or social problems in the initial phase?
Author
Parker
Year
2003
Study design
Cross-sectional
study
Level/Quality
n
351
Henningsohn
2003
Cross-sectional
study with control
group
C? Period after
treatment not
reported
866
Hardt
2000
B; small study
44
Gerharz
1997
Prospective study
pre-1yr post
surgery
Retrospective
follow-up 2.7 yrs
Boini
2004
Cohort study
SF-36 after 15
months
A2
Hsiao
2007
Systematic review
A1 Searching +
selecting +,
quality assessm +
44 patients alive
1 yr after
cystectomy
Patients up to 1
year after
cystectomy +
urinary diversion
7468 participants
in a cancer
prevention trial,
of which 88
developed
cancer
Men with
localised
prostate cancer
Jones
2006
Systematic review
A2 Searching +
selecting +
quality?
Women with
gynaecological
cancer
44
88
Population
Patients in
oncological
follow-up in
tertiary centre on
average 3 years
after diagnosis.
♂ after
treatment
bladder cancer +
follow-up
Results
32% suffered from a depression
QoL reasonably good; average score 43 (general population 50; SD
10)
Influencing factors: age +, gender M +, married +, social support +
After cystectomy+conduit, cystectomy+reservoir and neobladder
approx 20%19% distress due to ↓ intercourse+orgasm and erection
complaints. After radiotherapy, 17% distress due to intenstinal
complaints: 16% abdominal pain, 14% defaecation disorders. The
most distress as a result of urine retention
QoL postoperative strong reduction in physical functioning. Also
reduction in role limitations and emotional well-being. General
satisfaction with life not reduced
QoL reduced, especially in physical functioning. Almost 50% was
continent. Decrease in sexual activity (p<0.06)
Lower HRQoL scores for cancer patients, especially in the domains:
phys. functioning, physical role functioning and general health
domensions
Most frequently reported: urological complaints, sexual dysfunction
and intestinal disorders; The diagnosis causes psychological distress
with a changed self-awareness, worries about the effects of treatment
and distress related to the decision to be made in relation to treatment.
HRQOL is reported specifically per treatment
B1
Author
Hewitt
Year
2003
Study design
Cross-sectional
study
Level/Quality
B Large
representative
sample
Burgess
2005
Stommel
2004
Prospective cohort B
study + control
group
Prospective cohort B
study
n
4878
222
860
Population
Survivors of
cancer
compared to the
general
population
Women with
breast cancer
Results
Survivors of cancer more often have a poor health (odds ratio 2.97; CI
2.6, 3.4) and more often psychological problems (OR 2.2; CI 1.7, 2.8)
Older cancer
patients (breast,
lung, colon,
prostate)
Symptoms of depression decreased after 1 year, but the general wellbeing did not improve in this period
50% had depression and/or anxiety in the 1st year, 25% in the 2 nd
decreasing to 15% after 5 years.
Clinical question 2 Is there effective treatment for these problems, and/or is support justified for other reasons?
Author
Newell
Year
2002
Study design
Systematic review
Level/Quality
A2; small trials
n
34 trials
Rodin
2007
Systematic review
A2; small trials
11 trials
Schmitz
2007
Meta-analysis
Weighted mean
effect sizes
A2; small trials
22
studies
Rehse
2003
Meta-analysis
Moderate:
analysis unclear
and
unconventional
37
studies
Population
RCTs on the effect
psychological
intervention has on
outcomes of
cancer patients
RCT’s on the effect
of depression in
cancer patients
Studies on the
effect of
interventions
designed to
increase physical
activity on the
outcome of adult
cancer patients
Controlled studies
on the effect of
psychosocial
interventions on
quality of life of
cancer patients
Results
Only careful conclusions relating to efficacy of some interventions. Also
see details of results in the below table
2/6 Antidepressants 1 trials +
1/1 benzodiazepine vs. muscle relaxation +
2/4 non-pharmacological +:
specialised nurse care after 3 but not after 6 months +
orientation programme +
Good tolerance. Mean effect size (ES):
Cardioresp. Fitness:
3/4 +; ES 0.65( 0.22-1.09)
QoL 4/5 + ; ES 0.30 (–0.13-0.73)?
Pain 1/1 ES 1.64 (0.43-2.85)
Depression 2/5 + ES 0.44 (-0.13-1.01)?
Nontransparent analysis. No conventional methods used. No insight in
efficacy of type of intervention or study designs used.
Author
Allard
Year
2001
Study design
Systematic
Review
Level/Quality
A2
Osborn
2006
Meta-analysis
A2
Analysis method
unclear
Small non-blinded
RCTs
n
25
studies
(4 RCT)
involving
health
care
profs: 8
studies
(2 RCT)
involving
patients/
carers
15 trials
with
1492
patients
Population
Studies (amongst
other things,
RCTs) on the
effect of
'educational
interventions'
Results
Interventions aimed at health care professionals have little effect on pain
perception by patients. Interventions aimed at patients and carers do
appear to be effective (also short-term counselling with pain diary)
Studies on the
effect of cognitive
behavioural
therapy and
‘patient education’
on QoL of adult
cancer patients
CBT for depression: SMD 1.21;CI 0.22-2.19; for anxiety: SMD 1.99; CI
0.69-3.31; no effect in the case of pain or physical functioning, with QoL:
WMD 0.91; CI 0.38—1.44. Patient education did not have an effect on
any outcome.
Detailed results for Newell, 2002
anxiety
depression
general or overall effect
stress, distress
overall QAL
coping/control
vocational or domestic adjustment
interpersonal or social relationships
sexual or marital relationships
nausea
vomiting
pain
fatigue
overall physical symptoms
Music therapy; more research required for CBT, individual therapy, etc.
Nothing, more research for group therapy, structured counselling, etc
Unstructured counselling; music therapy. More research voor CBT, structured counselling, etc.
Structured counselling; more research on CBT, comm. skills training, etc
Structured or unstructured counselling
Group therapy; more research on CBT, relaxation therapy+communication skills
nothing
Structured or unstructured counselling
More research for therapist-delivered, individual interventions
More research on therapist-delivered interventions
No specific intervention recommended
More research on individual therapy, relaxation training, CBT, etc.
No specific intervention; more research on group therapy and CBT
No specific intervention
Clinical question 3 Is it known how long patients are heavily burdened as a result of these problems (for example, a clearly disturbed ADL function
or quality of life experienced), and within what period of time most patients regain their balance?
Author
Henningsohn
Year
2003
A
Study design
Cross-sectional study
with control group
Quality of study
A2; Period after
treatment not
reported
n
866
Kulaksizoglu
2002
Prospective cohort study
adequate
68
Zippe
2004
B
49
Hardt
2000
Prospective study with 5year follow-up
Prospective study pre-1
yr post surgery
B; small study
44
Kulaksizoglu
2002
Prospective cohort study
B adequate
68
Henningsohn
2003
Prospective study
B
616
Population
444 ♂ after treatment for
bladder cancer; 422
controls
Results
After cystectomy+conduit, cystectomy+reservoir and
neobladder approximately 20% distress due to ↓
intercourse+orgasm and erection complaints. After
radiotherapy 17% distress due to intestinal complaints: 16%
abdominal pain, 14% defaecation disorders. Most distress
due to urine retention
Bladder cancer patients
Functional scores strongly reduced after 3 mths, then
after radical cystectomy; improvement until starting level reached after 12 mths;
follow-up 2½ years
symptom score already high before surgery, after 12
months improvement especially with miction and sexual
complaints.
Sexually active ♂♂ after 86% was impotent 5 yr postoperative (erection disorder)
radical cystectomy
44 patients alive 1 yr
QoL postoperative strongly reduced in physical functioning.
after cystectomy
Also reduction in role limitations and emotional well-being.
General satisfaction with life not reduced
Bladder cancer patients
Functional scores strongly reduced after 3 mths, then
after radical cystectomy; improvement until starting level reached after 12 mths;
follow-up 2½ years
symptom score already high preoperatively, improvement
after 12 mths especially with miction and sexual complaints.
303 postcystectomy; 310 Psychological well-being 2-10 yr postcystectomy. > 10 yr =
controls
controls. Especially sexual dysfunction.
Clinical question 4 On the basis of this, what is the most suitable review moment regarding the requirement for follow-up?
Author
Year
Study design
Osse
2000
Syst review
Quality of
study
n
Population
Results
15
Instrum
ents
Patients with progressive No instrument was complete; spiritual issues and needs of
or metastatic cancer
relatives lacking. Instruments especially designed and
tested for research.
Gilbert
2007
instrument evaluation
315
bladder cancer patients
Differences in QoL demonstrated. BCI responsive for
functional differences and differences in complaints in the
urinary-, intestinal- and sexual domains.
Clinical question 5 Is it possible that health problems will develop at a later point in time as a result of the initial cancer or the cancer treatment, and
is it plausible that these long-term problems can be treated more effectively if detected earlier? Which sub-scenario (late effects) is appropriate on the
basis of these considerations?
Author
Allareddy
Year
2006
Hart
1999
Study design
Prospective cohort study
Level/ Quality
n
259
224
Population
Bladder cancer patients
8 yrs after diagnosis
Bladder cancer patients
1-23 yrs after radical
cystectomy
Results
High scores on QoL. After radical cystectomy: 89%
impotent; in the case of intact bladder 32%.
QoL generally good. Most problems with urinary diversion &
sexual dysfunction.
Clinical questions 6 through to 9 (answered for bladder carcinoma)
6. At which point in time can new cancer manifestations (local or regional recurrences, distant metastases or second primary tumours) occur?
7. Is there effective treatment for these cancer manifestations, and does treatment efficacy increase with earlier detection of the cancer?
8. Which diagnostics are the most suited to diagnosing treatable new cancer manifestations at an early stage in an accurate manner?
9. Which scenario for early detection is appropriate on the basis of these considerations?
Authors /
year
Level of
evidence
Study type
Population
(incl. sample
size)
Inclusion
criteria
Intervention
duration and
dose
Control
(golden
standard,
reference
test)
Outcome
Result /
conclusion
Comments,
notes
Malkowicz
2007
Bochner
2003
Westney
1998
-
review
-
-
-
-
-
-
-
-
review
-
-
-
-
-
-
-
C
Observat.
Retro.
33
Radical cystectomy
for UCC followed by
local recurrence
-
Prognosis of pat.
with local
recurrence is
poor despite
-
-
-
Authors /
year
Level of
evidence
Bajorin
1998
Study type
Population
(incl. sample
size)
Phase II trial
30
Sanderson
2007
C
Observat.
Prospect.
1069
Stein
C
Observat.
1054
Inclusion
criteria
Intervention
duration and
dose
Control
(golden
standard,
reference
test)
Outcome
Untreated patients Ifosfamide 1.5
with advanced UCC g/m2/d for a
bladder
duration of
3 days.
Paclitaxel 200
mg/m2 over 3
hours.
Cisplatin 70
mg/m2 on day
1 of every 28day treatment
cycle.
Max. of 6
cycles
Radical cystectomy
voor UCC blaas
-
Efficacy - no
response,
partial
response and
complete
response
Toxicity
Radical cystectomy
Survival
Result /
conclusion
therapy. Syst.
chemo offers
good palliation
ITP (ifosfamide,
paclitaxel and
cisplatin) is an
active, welltolerated
combination in
untreated
patients with
advanced UCC.
Lifelong risk of
recurrence in
upper urinary
tract.
Greatest risk
factor is tumor in
urethra.
Screening does
not detect
tumours before
symptoms
develop.
5-year disease-
Comments,
notes
Authors /
year
Level of
evidence
2001
Study type
Population
(incl. sample
size)
Retro.
Inclusion
criteria
Intervention
duration and
dose
Control
(golden
standard,
reference
test)
+ PLND for UCC of
the bladder
-
-
Intervention
duration and
dose
Control
(golden
standard,
reference
test)
-
-
Authors /
year
Level of
evidence
Study type
Population
(incl. sample
size)
Inclusion
criteria
Huguet
2003
C
Observat.
Retro.
5
Urethral recurrence
after cystectomy
with orthotopic
bladder
replacement
Nieder
C
Observat.
226
Radical
Outcome
Frequency
local & distant
recurrence
Outcome
Result /
conclusion
Comments,
notes
free and overall
survival 68%
and 66%
respectively.
Chance of
recurrence
dependent on
pathologic
subgroup.
Result /
conclusion
Urethral
recurrence after
orthotopic
bladder
replacement
rarely occurs.
Conservative
treatment is an
option in the
case of
superficial
recurrences.
Risk of urethral
Comments,
notes
Authors /
year
Level of
evidence
2004
Lin
2003
Population
(incl. sample
size)
Retro.
C
Sherwood
2006
Slaton
1999
Study type
C
Observat.
Retro.
6 case
reports +
review
Observat.
Retro.
24
Inclusion
criteria
Intervention
duration and
dose
Control
(golden
standard,
reference
test)
cystoprostatectomy
-
-
-
-
-
-
Urethrectomy due
to urethral
recurrence after
radical
cystoprostatectomy
as a result of UCC
-
-
382
Radical cystectomy
for N0-2, M0 UCC
bladder
Outcome
(Impact of
early detection
of urethral
recurrence on
the)
Overall
survival
-
Result /
conclusion
recurrence is
<4%. Lower risk
in case of
orthotopic
neobladder
(0.9%) than
supravesical
diversion (6.4%).
Delayed
urethrectomy
(i.e. after
cystectomy)
does not impact
survival.
No significant
difference in
survival between
patients that
have/have not
been screened
with urethral
washings
Stage-specific
follow-up
schedule after
radical
cystectomy can
Comments,
notes
Authors /
year
Level of
evidence
Hautmann
2006
Kuroda
2002
C
Study type
Population
(incl. sample
size)
Inclusion
criteria
Meta-analysis > 1300
(? according
to pubmed)
Orthotopic bladder
substitution
Observat.
Retro.
Radical cystectomy
for bladder Ca.
351
Intervention
duration and
dose
Control
(golden
standard,
reference
test)
Outcome
Result /
conclusion
reduce costs
and detect
recurrences and
complications in
an efficient
manner
Frequency
Respectively
urethral
1.5-5%
recurrence and 2-3%
recurrence
low
upper urinary
tract and longterm metabolic
disorders
Stage-specific
follow-up
schedule after
radical
cystectomy can
reduce costs
and detect
recurrences and
complications in
an efficient
manner.
Comments,
notes