European Journal of Oncology Nursing 28 (2017) 41e46

Contents lists available at ScienceDirect

European Journal of Oncology Nursing

journal homepage: www.elsevier.com/locate/ejon

Efficacy of preoperative uro-stoma education on self-efficacy after

Radical Cystectomy; secondary outcome of a prospective randomized
controlled trial
Bente Thoft Jensen, RN-Ph.D a, b, *, Berit Kiesbye, RN-ET a, Ingrid Soendergaard, RN-ET a,
Jørgen B. Jensen, MD a, Susanne Ammitzboell Kristensen, RN-MHSc a
a
Department of Urology, Aarhus University Hospital, Denmark
b
Department of Clinical Medicine, Centre of Research in Rehabilitation, Aarhus University, Denmark

a r t i c l e i n f o a b s t r a c t

Article history: Purpose: Radical Cystectomy with a creation of an uro-stoma is first line treatment in advanced bladder-
Received 26 January 2017 cancer. Enhancing or maintaining an individual's condition, skills and physical wellbeing before surgery
Received in revised form has been defined as prehabilitation. Whether preoperative stoma-education is an effective element in
2 March 2017
prehabilitation is yet to be documented. In a prospective randomized controlled design (RCT) the aim
Accepted 5 March 2017
was to investigate the efficacy of a standardised preoperative stoma-education program on an in-
dividual's ability to independently change a stoma-appliance.
Keywords:
Methods: A parent RCT-study investigated the efficacy of a multidisciplinary rehabilitation program on
Radical cystectomy
Self-care
length of stay following cystectomy. A total of 107 patients were included in the intension-to-treat-
Stoma care population. Preoperatively, the intervention-group was instructed to a standardized stoma-education
Supportive care program consisting of areas recognized necessary to change a stoma appliance. The Urostomy Educa-
Preoperative tion Scale was used to measure stoma self-care at day 35, 120 and 365 postoperatively. Efficacy was
Prehabilitation expressed as a positive difference in UES-score between treatment-groups.
Rehabilitation Results: A significant difference in mean score was found in the intervention group compared to stan-
Bladder cancer dard of 2.7 (95% CI: 0.9; 4.5), 4.3 (95% CI: 2.1; 6.5) and 5.1 (95% CI: 2.3; 7.8) at day 35, 120 and 365
Patient involvement
postoperatively.
Randomized controlled trial
Conclusions: For the first time a study in a RCT-design have reported a positive efficacy of a short-term
preoperative stoma intervention. Preoperative stoma-education is an effective intervention and adds to
the evidence base of prehabilitation. Further RCT-studies powered with self-efficacy as the primer
outcome are requested.
© 2017 Elsevier Ltd. All rights reserved.

1. Introduction
Radical Cystectomy (RC) with a subsequent creation of a urinary
diversion remains the most comprehensive procedure in urology
and first line treatment when diagnosed with muscle invasive
bladder cancer (MIBC) or high grade non-muscle invasive bladder
cancer (NMIBC) (Witjes et al., 2013).
Enhanced recovery after surgery (ERAS) is a multi-professional
evidence based concept to ensure patients receive optimal
* Corresponding author. Department of Urology, Palle-Juul Jensens Boulevard 99,
8200 Aarhus N, Denmark.
E-mail address: benjense@rm.dk (B.T. Jensen).
treatment and care (Kehlet and Wilmore, 2005). The genesis of the
ERAS-programs are based on the question “why is the patient still in
the hospital today?” given the following answer would clearly
address the patients individually recovery problems (Kehlet, 2015).
ERAS has successfully reduced length of hospital stay (LOS) across
surgical specialities and suggests, that the concept should be
expanded regarding its relative role in both pre- and postoperative
adjuvant therapies in major cancer surgery (Kehlet, 2015,Cerantola
et al., 2013).
Prehabilitation has been defined as the process of enhancing or
maintaining an individual's functional capacity before scheduled
surgery, aiming to improve the patient's tolerance to upcoming
physiological stress (Gillis et al., 2014). The aspect of optimising the
patient before surgery raises the dilemma prehabilitation versus

http://dx.doi.org/10.1016/j.ejon.2017.03.001
1462-3889/© 2017 Elsevier Ltd. All rights reserved.

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42 B.T. Jensen et al. / European Journal of Oncology Nursing 28 (2017) 41e46
rehabilitation. Based on the aforementioned aspects the question is
whether adding a preoperative patient-education program in
stoma care is an effective way forward to further optimise patient
outcomes. Historically, the focus within stoma care literature has
been on the experiences of the affected individual (O'Connor,
2005,O'Connor, 2003). Urostomy care requires manual skills and
emotional adaption in order to secure self-efficacy (Kristensen
et al., 2013) and there is mounting evidence that stoma care abil-
ity is the most important variable predicting positive adjustment to
life with a stoma and increase the perception of Quality of life (QoL)
(O'Connor, 2005,Danielsen et al., 2015,Vujnovich, 2008,Metcalf,
1999). A daily postoperative education-program in stoma self-
care is a well known intervention and occurs during the patient's
recovery in hospital after surgery (Metcalf, 1999,Vujnovich,
2008,Konya et al., 2006). However, follow up remains limited and
significant unmet needs are described by survivors such as lack of
early stoma-education and patient-involvement (Mohamed et al.,
2014). Moreover, the literature reports that approximately only
50% of the patients adheres to stoma self-care two yeas post RC
with a subsequent creation of an ileal conduit (Tal et al., 2012).
Providing the patient with adequate information and education
before surgery is paramount and preoperative patient involvement
is warranted in the RC-pathway (Mohamed et al., 2014). The posi-
tive impact of pre-operative stoma marking on clinical and patient
reported outcome (PRO) has been reported (Salvadalena et al.,
2015,McKenna et al., 2016). Thus, it has been hypothesized that
adding preoperative stoma care education may be effective and
improve self-efficacy as defined by Bandura (1977). So far preop-
erative stoma education has been discussed as consensus for good
clinical practice in small descriptive studies and reviews based on
expert knowledge (Kozell et al., 2014,Danielsen and Rosenberg,
2014), but the efficacy on preoperative stoma self-care skills has
not been documented in a randomized design. In a prospective
randomized controlled trial (RCT) the aim of this study was to
investigate the efficacy of preoperative stoma-education on stoma
self-care skills in patients undergoing RC with a subsequent crea-
tion of an ileal conduit because of bladder cancer.
1.1. Hypothesis
Preoperative stoma education improves stoma self-care
following RC.
2. Methods
2.1. Participants
A parent prospective RCT investigated the efficacy of a multi-
disciplinary rehabilitation program on LOS following RC (Regis-
trated in Clinicaltrial.gov Database NCT01329107). A total of 107
patients were included in the intension-to-treat population
distributed by 50 patients in the intervention group and 57 patients
in the standard group. The process of recruiting and randomization
has been earlier reported (Jensen et al., 2015). The intervention
group was instructed pre-operatively to a standardized pre-
habilitation program consisting of both physical training and
stoma-education. The content of the standardized physical pre-
habilitation program and the results of physical training are re-
ported elsewhere (Jensen et al., 2016).
Each patient was stoma sited according to international guide-
lines (Geng et al., 2009,Kozell et al., 2014). Five weeks post-surgery
(day 35 post-surgery), all patients had a visit in the urostomy out-
patient clinic, as standard of care, by two Urological Enteral Stoma
Therapy Nurses (ET). A full change of appliance was performed and
the patient was individually guided in case of lack of capacities in
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any of the defined stoma self-care skills according to the Urostomy
Education Scale (UES) (Kristensen et al., 2013). All patients included
in this RCT-study were furthermore followed up by the project
nurse regarding status of stoma self-care and other aspects related
to the RCT-study at four and twelve months post-surgery (day 120
and day 365 post-surgery).
2.2. Intervention
The two ET's introduced and instructed the intervention group
to basic stoma care and change of appliance using a training kit
with an artificial stoma. The education program included basic
skills to optimize the ability to perform independently stoma care.
The patient was encouraged and recommended to perform stoma
care and change of appliance, both one-piece and two-piece sys-
tem, at least twice at home providing them with training kits and
appliances. The patient was informed about the urostomy and life
with a urostomy related to the individual patient's life and life style.
Every patient had a follow up prior to surgery where the ET
observed self-care skills regarding stoma care and change of
appliance.
The standard group did not receive any of the aforementioned
instructions or information prior to surgery.
2.3. Measurements
Progress in stoma self-care skills was measured using the vali-
dated UES; a standardized, validated and evidence based tool to
document patients' level of stoma self-care skills (Kristensen et al.,
2013,Kristensen and Jensen, 2016). The instrument was developed
in collaboration with representatives from the European Associa-
tion of Urology Nurses and yet a standard tool recommended by the
American College of Surgeons. The UES is validated concerning face,
content and construct validity. Moreover, UES is tested for reli-
ability and found to be highly reliable among urology nurses with
different level of experience in stoma care (Kristensen and Jensen,
2016,Kristensen et al., 2013). The scale is a quantitative scale aiming
to determine individual urostomy self-care skills at any timeslot
among patients undergoing RC. Areas recognized as standard pro-
cedure in urostomy care were identified and yet categorized into 7
skills necessary for changing a urostomy appliance (Fig. 1). The
seven skills are; reaction to the stoma, removing the stoma appli-
ance, measuring the stoma diameter, adjusting the size of the
urostomy diameter in a new stoma appliance, skin care, fitting a
new stoma appliance, and emptying procedure. Each skill is rated
on a 4-point scale; possible scores range from 0 to 3 points. A score
of 0 describes a patient being totally dependent on the nurse. A
score of 1 describes a patient participating in the skill but needs
assistance from the nurse. A score of 2 points describes a patient
requiring verbal guidance from the nurse to complete the skill. A
score of 3 points describes a patient who can complete the skill
independently of the nurse. Possible cumulative scores vary from
0 to 21 points; higher scores indicate greater self-care skill
acquisition.
2.4. Statistics
Differences in background data was tested by Students T-test for
continuously variables, Pearson's Two-sided Chi esquare Test for
dichotomous variables and Ranksum Test for categorical. Efficacy
was defined as a mean significant improvement in stoma self-
efficacy between treatment groups and tested using the Student's
T-test. The analyses were performed using an-intension-to treat
approach (Schulz et al., 2010). Data was presented using a mean
value including 95% Confidence Interval (CI). All statistical analyses
 B.T. Jensen et al. / European Journal of Oncology Nursing 28 (2017) 41e46 43

Skill 0 points 1 point 2 points 3 points

1. ReacƟon to the stoma The pa ent shows The pa ent has seen and The pa ent has seen and The pa ent copes with
no interest in/has touched the stoma on the touched the stoma on the stoma and is pre-
difficulty coping with ini a ve of the nurse his/her own ini a ve paring for the future
the stoma.
2. Removing the stoma The nurse removes The pa ent needs The pa ent needs verbal The pa ent can remove
appliance the stoma appliance. assistance to remove the guidance to remove the the stoma appliance
stoma appliance stoma appliance independently
3. Measuring the stoma The nurse measures The pa ent needs The pa ent needs verbal The pa ent can measure
diameter the stoma diameter assistance to measure the guidance to measure the the stoma diameter
stoma diameter correctly stoma diameter correctly correctly independently
4. AdjusƟng the size of The nurse cuts the The pa ent needs The pa ent needs verbal The pa ent can cut the
the urostomy size of the urostomy assistance to cut the size guidance to cut the size of size of the urostomy
diameter in a new diameter of the urostomy diameter the urostomy diameter diameter independently
stoma appliance
5. Skin care The nurse cleans and The pa ent needs The pa ent needs verbal The pa ent can clean
dries the skin assistance to clean and guidance to clean and dry and dry the skin inde-
dry the skin the skin pendently
6. Fiƫng a new stoma The nurse fits a new The pa ent needs The pa ent needs verbal The pa ent can fit a new
appliance stoma appliance assistance to fit a new guidance to fit a new stoma appliance
stoma appliance stoma appliance independently
7. Emptying procedure. The nurse performs The pa ent needs The pa ent needs verbal The pa ent can perform
(Emptying bag and the emptying pro- assistance to perform the guidance to perform the the emptying procedure
a aching/detaching cedure emptying procedure emptying procedure independently
night bag)

Total points:

Fig. 1. The Urostomy Education Scale.

were performed using STATA version 13, Stata Corp. Texas (US).
2.5. Ethical considerations
Permission to perform the study and collect patient-data was
approved by the Scientific Ethical Committee of Central Denmark
Region and the Danish Data Protection Agency (Nbr, 2010-41-
4306). Written informed consent was requested from all patients
accordingly. The intervention was not considered harmful to pa-
tient and only a few patients redraw totally for other reasons.
3. Results
each skill on the UES at all three time slots during the follow up
period. Throughout the follow up period, a continuous decrease in
score was found regarding all skills in the standard group compared
to the intervention group.
The UES total score is a combined score of seven skills and it was
analysed whether a specific skill posed a greater challenge for the
patient in the standard group compared to the intervention group
as implied in Fig. 2. The score of each skill was tested between
treatment groups (data not shown). Postoperatively the interven-
tion group displayed a significant positive difference at any time
point and in any skill except from skill number 4 at day 35
postoperative.

A total of 107 patients were included in the parent study as 4. Discussion

earlier reported (Jensen et al., 2015). The background information
was reported in Table 1. Excluding patients without an urostoma
diversion (12 patients with Neobladder and 3 patients with
Continent Cutaneous Pouch) or death within 7 days (2 patients)
revealed a total of 90 patients in the study group; 44 patients in the
intervention group and 46 patients in the standard group. The
drop-out rate in the follow up period ranged from 14 to 26% in the
intervention group and from 21 to 28% in the standard group.
However, there were no significant difference at any time point
between the two groups (35 days (p ¼ 0.3), 120 days (p ¼ 0.5) and
365 days (p ¼ 0.8), respectively). The main reason for drop-outs
was advanced disease.
No statistical significant difference (p ¼ 0.35) was found in mean
self-efficacy score between treatment groups during admission.
However, a significant increase in the total stoma self-care score of
2.7 points (95% CI: 0.9; 4.5) was found in the intervention group
compared to the standard group at day 35 post-surgery. Moreover,
throughout the study period the difference increased further by 4.3
points (95% CI: 2.1; 6.5) and 5.1 points (95% CI: 2.3; 7.8) at day 120
and 365 respectively. Fig. 2 shows the mean score measured for
Preoperative stoma-care intervention is an effective way for-
ward to optimize urostoma self-care as an element in a multi-
disciplinary pathway. These results clearly indicate preoperative
stoma education has a role in further endeavours to improve the
patient pathway and optimize outcome. The study provides for the
first time results suggesting that preoperative uro-stoma education
is effective immediately and remains effective during the first year
postoperatively.
The role of the ET and the importance of the service provided for
patients have been regularly appraised and recognised in the
literature (Tal et al., 2012; Piwonka and Merino, 1999,Kozell et al.,
2014,Davenport, 2014). It is stated as being imperative for the
rehabilitation process that a patient with a newly formed stoma
and related families are supported, educated and advised by the
specialized nurse (Metcalf, 1999; Piwonka and Merino, 1999).
The challenge for nurses working within this field has been
three-fold; so far it has not been possible to communicate this
importance in terms of efficacy and evidence-based care and cost-
effectiveness analysis has not been performed (Davenport, 2014).

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44 B.T. Jensen et al. / European Journal of Oncology Nursing 28 (2017) 41e46

Table 1
Demographic and clinical variables at baseline. Efficacy of a multimodal rehabilitation programme in patients undergoing radical cystectomy at Aarhus University
Hospital 2011e2013.

Intervention Standard P
n ¼ 50 n ¼ 57

Gender, n (%) 0.38

Men 39 (78) 40 (70)
Women 11 (22) 17 (30)
Age 0.48
Mean (SD) [95% CI] 68.5 (9.8) [66.4; 72.0] 70.6 (9.2) [68.1; 73.0]
Max Clinical Tumour Stage, n (%) 0.55
T0 2 (4) 1 (1)
T1 10 (20) 14 (25)
T2 26 (52) 24 (42)
T3 12 (24) 18 (32)
T4 0 0
Comorbidity (Charlson Indexa), n (%) 0.82
0 No 1 (2) 0 (0)
1e2 Low 16 (32) 14 (25)
3e4 High 23 (46) 31 (54)
5 Severe 10 (20) 12 (21)
Urinary Diversion, n (%) 0.61
Ileo-cutano ad Modum Bricker 44 (88) 48 (84)
Neobladder 5 (10) 7 (12)
Lundiana Pouch 1 (2) 2 (4)
Nutritional Risk Score (NRS-2000), n (%) 0.26
3 “ at risk” 14 (28) 9 (16)
<3 36 (72) 48 (84)
BMI 0.77
mean (SD) [95% CI] 26 (4) [25; 27] 26 (5) [25; 27]
Marital Status, n (%) 0.56
Living with a partner-yes 31 (62) 32 (56)
Living alone-yes 16 (32) 21 (37)
Missing 3 (6) 4 (7)
Length of stay 0.68
Median (range) 8 (3e30) 8 (4e55)
a
Adjusted for age.

The results of this study add new evidence to the RC-pathway and
may propose a solution for the aforementioned dilemma pre-
habilitation versus rehabilitation.
At day 35, 120 and 365 post-surgery a significant difference in
total UES-score was shown varying from 2.7 to 5.1 points
throughout the study period. Whether these differences can be
considered as clinical relevant may be questionable. Looking at
Fig. 1, it can be seen that a difference of 3e5 points distinguish the
level of self-care from being a patient in need of some verbal
guidance from the nurse (e.g. a score of 16 points) to being a patient
independently performing stoma care (e.g. a score of 21 points).
Knowing that the ability to perform stoma care independently is
associated with QoL and positive adjustment to a life with a stoma,
these results are of highly clinical relevance (Vujnovich,
2008,Danielsen et al., 2015,Metcalf, 1999,O'Connor, 2005).
Because of the high reliability of the UES, the differences of 3e5
points are therefore considered to express a real time difference in
stoma self-care and not because of unreliability. However, further
validation regarding the exact weighting among the skills and
thereby threshold values marking the levels of self-care are yet to
be explored in a greater multi-site study.
The intervention group maintain same high level of stoma self-
care as opposed to the standard group whose competencies
decrease continuously over time especially regarding skill number
3, 4 and 6 (Fig. 2). That calls for attention in future planning and
priority in daily clinical practice of stoma care education.
During hospitalisation, there was no significant difference be-
tween treatment groups although the daily clinical experience was
different with the understanding that the intervention group was
immediately more proactive in taking part of changing the
appliance although not proved. In the analysis of postoperative
scores, a mean value was calculated during the period of day 1 to
day 7. The data material was not big enough to distinguish treat-
ment groups in the very early postoperative days. Future studies
may be able to show a difference in the very early period when
correctly powered with a higher number of patients. It is however
observed in the literature, that a preoperatively preparation for a
stoma facilitates the transition process and reduces the impact of
the event, allowing the confrontation and the development of
strategies to assist in self-care. The physical and psychological di-
mensions may be affected by the lack of guidance in the preoper-
ative period, making it challenging to face the postoperative period
(Mota et al., 2015). Two Danish studies have furthermore shown
how patients shift from observer towards participator and nurses
change role from “hands on” to “advisor” when introducing pre-
operative stoma education (Olsen and Jacobsen, 2016). Addition-
ally, patients have expressed unmet needs and a lack of adequate
training using stoma appliances (Mohamed et al., 2014) and request
early involvement in stoma care and more information on post-
operative self-care (Mohamed et al., 2016). This knowledge sub-
stantiates that preoperative stoma education has a future role in RC
pathways and supports the tendency towards partnership and
patient involvement in the rehabilitation process (Alrø and
Skadkær Møller, 2016).
4.1. Limitations
The overall limitation to this RCT-study is the use of secondary
outcome. There were no power calculations regarding sample size
and no written pre-considerations regarding expected efficacy on

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 B.T. Jensen et al. / European Journal of Oncology Nursing 28 (2017) 41e46 45

stoma self-care postoperatively. Thus, the study was not powered

for stoma self-care outcome and the results may be carefully
interpreted. However, this study is the first measuring efficacy of

Skill 7
preoperative uro-stoma education. The findings are encouraging
for future efforts to set up a multi-centre prospective RCT using the

Skill 6
results for a more precise, and qualified design.

Standard
It could be questioned whether the intervention group may be
biased because of the added preoperative physical training inter-

Skill 5
365 post-operative days

vention leading to a higher muscle capacity and significant earlier

time to independently perform ADL activities postoperatively

Skill 4
(Jensen et al., 2015, 2016). This could indicate a potential surplus

Intervention
energy to perform stoma self-care. Nevertheless, Younis et al.'s
study found that preoperative stoma education significantly

Skill 3
reduced “delayed discharge” until the patient was able to perform
Skill 2
independent stoma care (Younis et al., 2012). This suggests that
stoma education has a role in prehabilitation.

5. Conclusion
Skill 1

For the first time, a study in a RCT-design have reported positive

Fig. 2. Level of Stoma self-care measured on the UES at day 35, 120 and 365 post-operative.

3 2 1 0
efficacy of a short-term preoperative stoma intervention. The re-
sults suggest that preoperative stoma-education is an effective
intervention and add to the evidence base of prehabilitation.
Further RCT-studies powered with self-efficacy as the primer
Skill 7

outcome are required.

Skill 6

Conflicts of interests
Standard

The authors state no conflicts of interest.

Skill 5
120 post-operative days

Acknowledgements
Skill 4
Intervention

This work was carried out in a public health care system. The
Skill 3

study was supported by Aarhus University Hospital (Denmark), The

Dansac Foundation (Denmark), Inge Eriksen Foundation
(Denmark), Helsefonden (Denmark), ML Joergensen Foundation
Skill 2

(Denmark), Novo-Nordic Nursing Research Foundation and The

Danish Cancer Research Foundation. The funding sources had no
Skill 1

influence or involvement in the study design, collection, analysis,

interpretation of data, writing the manuscript or the decision to
3 2 1 0 submit the article for publication.
The Study group acknowledge Mrs. Nora Love Retinger, Me-
morial Sloan Kettering Cancer Center (US) for language support and
proof reading of the article.
Skill 7

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