Research Article
Patients’ Evaluation of an Educational and Training Experiential Intervention (ETEI) to Enhance Treatment Decision and Self-Care Following the Diagnosis of Muscle Invasive Bladder Cancer
Nihal E Mohamed1*, Sailaja Pisipati2, Mario Cassara3, Sarah Goodmanc3, Cheryl T Lee4, Cynthia
J Knauer1, Reza Mehrazin1, John P Sfakianos1, Barbara Given5, Diane Z Quale6 and Simon J
Hall7
1Department of Urology and Oncological Sciences, Icahn School of Medicine at Mount Sinai, USA
2University of Nevada Reno School of Medicine, USA
3Department of Public Health, Icahn School of Medicine at Mount Sinai, USA
4Department of Urology, University of Michigan, USA
5College of Nursing, Michigan State University, USA
6Bladder Cancer Advocacy Network, USA
7Smith Institute for Urology, North Shore/LIJ Health System, USA
*Corresponding author: Nihal E. Mohamed, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1272, New York, NY, 10029-6574, USA
Published: 18 Sep, 2017
Cite this article as: Mohamed NE, Pisipati S, Cassara M,
Goodmanc S, Lee CT, Knauer CJ, et al.
Patients’ Evaluation of an Educational
and Training Experiential Intervention
(ETEI) to Enhance Treatment Decision
and Self-Care Following the Diagnosis
of Muscle Invasive Bladder Cancer. Clin
Surg. 2017; 2: 1617.
Abstract
Objectives: This study examines patients' evaluation of an educational and training experiential
intervention (ETEI) developed to enhance muscle invasive bladder cancer (MIBC) patients'
treatment decision-making and post-treatment self-care.
Methods: Participants were recruited from the Mount Sinai Medical Center and via the National
Bladder Cancer Advocacy Network website between December, 2011 and September, 2012. Data
were collected via individual interviews and electronic medical record review. Qualitative analysis
of patients' reaction and evaluation of the proposed content of the ETEI modules was performed.
Results: Data were collected for a total of 30 study participants (26.7% women; 93.0% non-Hispanic
White) who underwent cystectomy and urinary diversion for MIBC. Mean age was 66.6 years. 50%,
43.3% and 6.7% of patients were treated with ileal conduit, neobladder and continent reservoir
respectively. High satisfaction rate with the educational and training components was reported.
Conclusion: The study results emphasize the importance of the proposed ETEI and appropriateness
of the informational and training modules for both patients and their caregivers. Such an intervention
will help reduce the burden of care on patients, care-givers and care-providers.
Practice-implications: There could potentially be an increased need for resources – educational
booklets, audio-visuals, trained health care personnel, length +/- number of appointments.
Keywords: Urothelial Carcinoma of the Urinary Bladder; Muscle Invasive Bladder Cancer;
Radical Cystectomy; Urinary Diversion; Unmet Need; Educational; Training Experiential
Intervention
Introduction
Bladder cancer (BC) is the fifth most common cancer and the fifth leading cause of cancer
deaths in the United States (US). According to the Surveillance, Epidemiology, and End Results
(SEER) database, it is estimated that 76,960 new cases of BC will be diagnosed in 2016 and 16,390
patient’s die of this disease [1]. There has been a decreasing trend in mortality from BC in the
US and Europe [2,3], possibly reflecting reduced occupational exposure to carcinogens, reduced
incidence of smoking and increased standard of care [4,5].
25% of the newly diagnosed BC are muscle invasive requiring aggressive radical surgery or
radiotherapy with or without chemotherapy [6]. The outcomes, however, remain poor despite aggressive systemic treatments [7,8]. Muscle invasive bladder cancer
(MIBC) is a potentially lethal malignancy and continues to pose
an enormous challenge, especially in older patients. The current
standard of care for non-metastatic MIBC is radical cystectomy (RC)
with lymphadenectomy, followed by urinary diversion (UD) to either
a cutaneous stoma or the existing urethra, thus providing excellent
local control [9-13]. Neoadjuvant chemotherapy has been proven to
enhance survival outcomes in MIBC, by eliminating residual disease,
although it is not exempt from side-effects [14].
The three methods of UD currently used are incontinent diversion
with a stoma (e.g., ileal conduit, IC), orthotopic continent UD (e.g.,
neobladder), and continent cutaneous diversion (CCD, e.g., Indiana
pouch) [15]. Each of these procedures is associated with a distinct
set of challenges and complications, as well as unique psychological
burdens [9-13]. The neobladder most closely resembles the native
bladder and preserves continence, reducing the need for regular longterm
intermittent catheterization associated with CCD [16]. The IC
presents shorter recovery time and is largely free of the metabolic
complications associated with the orthotopic neobladder procedure.
However, the IC requires the use of a stoma and urine collection bags,
which patients may find upsetting and obstructive to post-operative
lifestyle [16].
RC and UD is associated with high surgical morbidity and
mortality [17,18]. Although the incidence of severe complications has
shown a declining trend, they are still an issue of great concern in 30%
of patients during in-hospital stay and in up-to 60% of patients within
90 days [17-26], thereby prolonging the length of hospital stay and
negatively impacting recovery [27,28]. Careful maintenance of the
surgical and UD sites is integral to promoting recovery and restoring
urinary function. Surgeons must also refine pre- and postoperative
strategies to enhance patient recovery following cystectomy.
Emphasis must be placed on improving pre-operative nutritional
status, educating patients about red-flag symptoms, enhancing
recovery protocols, counseling patients, setting realistic goals and
expectations, and training patients regarding stoma care [29-32].
RC and UD procedures can significantly alter patients’ quality of
life (QoL) and psychosocial adjustment. Sexual potency and urinary
incontinence are recurring issues, often directly attributable to the
diversion process itself [33]. Moreover, no UD technique is clearly
better in terms of post-operative QoL and psychosocial adjustment.
Preference for a certain procedure is largely based on patient-specific
characteristics such as age, comorbidities, physical and manual
dexterity, prospective surgical issues, and lifestyle needs [34,35].
Each type of diversion carries its own set of psychological burdens,
including negative body image and intrusive nighttime awakenings
[34-36]. Poor body image has shown to be more common among
patients with conduits, which leads many newly diagnosed patients
to opt for the neobladder despite the possibility of reduced urinary
continence. Insecurities are mostly due to the stoma’s appearance and
required continuous care [34-36].
IC is associated with stomal difficulties (prolapse, retraction,
stenosis, skin irritation, urinary leakage, difficulty in proper positioning
and securing stomal appliance), renal deterioration and recurrent
urinary infections [37-40]. Furthermore, depending on the absorptive
characteristics of different bowel segments used for reconstruction,
IC diversion may lead to one of various metabolic abnormalities such
as metabolic acidosis, hypochloremia, hypokalemia, hypocalcemia.
These metabolic derangements, however, are more of a concern
with neobladder when compared to an IC. Additionally, neobladder
requires life-long monitoring, frequent irrigation of the reservoir for
mucus clearance, and urethral surveillance. It also features a higher
rate of nocturnal incontinence and metabolic disorders [39,41,42].
Patient-related factors have a significant role in determining the
type of UD. Elderly patients typically opt for a conduit as the operation
is relatively simpler and takes significantly less time when compared
to orthotopic or continent reservoir reconstruction [43], and
minimizes incontinence issues. Gender also influences the selection
of diversion type; fewer women are eligible candidates for neobladder
procedures due to increased chance of voiding dysfunction when
compared to men [44]. Women tend to require extensive individual
evaluation prior to the procedure to ensure that the tumor is not
located at the bladder neck and that there is a clear urethral margin
at the time of cystectomy [17]. Patient preference further varies based
on treatment-related values, expectations, cultural background, and
socioeconomic status [45]. Preoperative continence can reasonably
predict post-operative urinary function as preoperative urinary
problems may worsen after the orthotopic neobladder procedure (e.g.,
increased urinary incontinence and higher likelihood of intermittent
catheterization).
Lastly, patient preference also plays an important role in procedure
decisions. While the IC might offer a less complicated method of
bladder evacuation, its impact on body image and the possibility of
urine leakage makes it less attractive especially for younger patients.
The occasional leakage following the neobladder procedure may
seem tolerable to those who fear the conduit's impact on body image
and the associated urine collection bag and stoma care. Existing
comorbidities (e.g., inflammatory bowel disease, prior radiotherapy)
may preclude the use of the bowel for the neobladder, which leads
some patients to opt for the IC [46-49]. Physician preference can also
influence selection of UD type, as can surgeon-specific characteristics
such as age, race, location of practice, surgical volume and surgeon
preference [50,51].
The entire process of evaluating disease severity, navigating
treatment options, recovering from surgery, and acclimating to
postoperative lifestyle changes is undoubtedly rife with difficult and
multifaceted decisions. Given the challenges both inherent and specific
to MIBC, it is critical to ensure proper support for patients throughout
each phase of diagnosis, treatment, and recovery. A recent study by
Lee CT et al. found that even among NCI-designated institutions,
few treatment centers employ active BC support groups, survivorship
clinics, or community resources for education and patient navigation
[52]. Patients with MIBC usually receive post-operative educational
support regarding self-care strategies such as the utility of stomal
appliances and catheterization, yet there remains a lack of research on
the actual decision-making process over the course of treatment, as
well as on the possible benefits of more extensive educational support
for patients prior to surgery. It is therefore critical to investigate BC
patients’ decision-making processes, which depend upon adequate,
ongoing educational support.
In this context, our study evaluated the acceptability of an
educational intervention that we developed to enhance MIBC patients’
treatment decisions and QoL. Improved knowledge of how patients
understand and approach their disease can better inform doctors’
care throughout the diagnosis and treatment process. This study
therefore explores the merits of a certain BC educational program
meant to both inform patients' decision-making and improve their long-term post-operative satisfaction.
Table 1
Study Design
Study design and methods
This study evaluated patients’ acceptability and preliminary
evaluation of an educational and training experiential intervention
(ETEI), which was designed to enhance treatment decisions and
postoperative QoL. As a first step in designing this intervention, we
gathered information from patients about their unmet informational
and supportive care needs before and after MIBC treatment and
held individual, qualitative, semi-structured in-depth interviews.
An extensive literature review was conducted to explore additional
areas of needs and potential challenges experienced by MIBC patients
across the disease trajectory [34,36,53,54]. Iterative reviews of the
content of the ETEI were conducted by the research team till an
agreement was reached on the content of the ETEI final version [55].
Description of the educational and training experiential
intervention (ETEI): The development of the content of the ETEI’s
educational and training components was guided by the traditional
model of Self-Regulation Theory (SRT), the Ottawa Decision Support
Framework [56-58] results of the qualitative, semi-structured indepth
interviews, literature reviews, and experts’ input. The two
components of the ETEI were designed to 1) provide accurate
information about MIBC treatment and diversion options, 2) create
realistic expectations, 3) identify and explore values and goals to
provide a context for making “preference sensitive” decisions and
choices, 4) validate feeling and concerns and provide emotional
support, and 5) provide information and tangible support to enhance
skills needed for stoma and pouch care following treatment. The
educational components (ETEI information) were designed to be
provided as part of a 1-hour nurse-led session and a follow-up call
to discuss treatment options and respond to patients’ questions and
address their worries and concerns. Four booklets were provided to the
patients describing BC treatment options and self-care requirements
associated with each treatment option, along with a question list for
the doctor. The training component involves trying out a stoma bag
filled with saline solution for about 24 h - 48 h to get a sense of how it
feels to have an IC-related stoma [Table 3] [55].
Selection and recruitment of participants: Between January
2010 and January 2012, we recruited patients with MIBC at the Icahn
School of Medicine at Mount Sinai’s (ISMMS) Urology department.
Patients between 18 and 85 years of age who underwent RC and UD
for urothelial carcinoma of the bladder were eligible to participate.
Patients with metastatic disease, cancer recurrence, or secondary
cancers were excluded from our study. Of the 35 eligible patients, 19
(54.28%) agreed to participate in the study. Reasons for declining to participate included lack of interest, limited time, and poor health
condition. Patients were also recruited via the Bladder Cancer
Advocacy Network’s (BCAN) online advertisement, which required
the same eligibility criteria using self-reported medical information.
All 11 of the BCAN advertisement respondents were eligible and
agreed to participate. All study participants (N=30) consented and
were compensated with a $50 gift card.
Ethical issues and approval: Prior to each interview, patients’
verbal and written informed consent was obtained. Participants were
given a detailed description about the aim of the study and ensured
anonymity and confidentiality of responses. The study was approved
by the Institutional Review Board (IRB) of ISMMS and was funded by
the American Cancer Society (ACS).
Data collection: To facilitate informative discussions with
patients about the content and acceptability of the ETEI, we developed
a semi-structured interview guide using both expert opinions and
results of our prior extensive reviews of cancer patients’ and survivors’
unmet needs [36]. Data were collected through in-person (N=9) or
telephonic (N=21) interviews (median time: 60 min; range: 30 min - 90
min), using a semi-structured interview guide [Table 1]. To maintain
uniformity, the same individual (NM) conducted all interviews.
Plain language was used to explain all medical terminology. Study
participants were asked 11 questions about the type of information
and training they wished they had received beforehand, and the best
times to have received them [Table 1]. Brief description of the ETEI
intervention modules with illustrations depicting different treatment
options and examples of self-care strategies were provided and
participants were asked to provide their input on these modules and
related educational materials [Table 3]. Participants were also asked
about their preference for similar educational materials for their
spouses. The open-ended interview protocol allowed participants
to narrate their experiences and views in broad personal detail. All
interviews were audio recorded and transcribed, and a member of
the research team made additional written notes. Data was coded
during collection and completed upon saturation (i.e., when no new
or relevant data emerged).
Data analysis: A qualitative analysis using the template analysis
approach that involves developing a template/coding guide for
sorting narrative data was employed. Content analysis of participants’
responses using the template analysis approach also included
checking for representativeness of the data, data triangulation (i.e.
use of multiple methods to interpret data, such as comparing coding
of interviews with written notes) and verification for external validity
[59-61]. The coding guide was designed to identify narrative themes
related to the acceptability and patients’ evaluation of the content of
the ETEI. The interview questions directly reflected the template/
coding guide’s thematic categories of treatment information, skill
learning, spousal information, and best time for intervention. Group
discussion and negotiation among the members of the research
team helped resolve any conflicts regarding which codes should be
assigned to certain clusters of data. All data were coded using Atlas.ti
software [62]. We obtained ISSMS patients’ demographic data such as
age, treatment date, and treatment type from medical charts to assist
in analysis. For patients recruited from BCAN, we relied on patients’
self-reported information [Table 2].
Table 2
Table 3
Results
Data were collected for a total of 30 study participants (26.7%
women; 93% non-Hispanic White) who underwent RC and UD for
MIBC. Mean age was 66.6 years (range: 52–82; standard deviation
[SD] = 8.99). Half of the study population were treated with IC (50%,
N=15), while 43.3% (N=13) were treated with neobladder and the
remainder (6.7%, N=2) with the continent reservoir. Table 1 depicts
study participants’ demographics and clinical characteristics. Table
3 summarizes the results by depicting the acceptability of the ETEI
modules. Overall, patients expressed high satisfaction with the
educational and training components of the ETEI, as indicated by
their reaction to proposed content and plans of intervention delivery.
The educational module of the ETEI: Treatment information
All participants (100%) desired substantial information about
the various UD options available and their outcomes. All agreed
that it would have been beneficial to receive full and comparative
information about UD options and their side-effects as described by
the informational module of the ETEI. 90.5% believed they would
have benefited from a prepared list of general questions describing
and comparing treatment options during their consultations. 4.8%
did not think such a list would have been useful, as they relied
solely on their physician’s treatment recommendations unique to
their situation. Moreover, 86.7% expressed that viewing the ETEI
proposed medical illustrations or other visual representations of
each treatment option would have enhanced their understanding
of how each UD procedure changes the urinary tract’s anatomy
and functioning. 90.5% felt that seeing the ETEI proposed pictures
of stomal appliances and catheters would have helped them prepare
for potential challenges following surgical intervention. 85.7% agreed
that preoperative discussion with a healthcare professional regarding
the stoma’s location and care would have been beneficial, even if they
ultimately chose another treatment option. About 5% of interviewees
felt that they had already received enough information from their
physicians.
The training module of the ETEI: Skill learning
The majority of participants believed that they also would have
benefitted from preoperative skills-based education. 71.4% agreed
that an opportunity to wear a stoma bag for 24 to 48 hours prior to
surgery would have allowed them to preemptively experience stomarelated
care issues, while 23.8% felt that this might have raised their
anxiety levels. 14% of patients agreed that practicing stoma care skills
before surgery (e.g., how to use catheters and stoma appliances)
would have effectively prepared them for life after surgery. However,
an equal proportion of the study population (14%) also indicated
preference for post-surgical training on the stoma care skills, rather
than pre-surgical training, largely because the emotional stress of
cancer diagnosis and treatment consideration might have affected
their ability to understand complicated self-care information at the
time.
Spousal information provided by the ETEI
Most participants (90.5%) recommended that their spouses
receive the same educational materials, especially since many of them
indicated relying upon their spouses and partners for post-operative
health care and support. Participants who cared for themselves postoperatively
felt that their spouses would have voluntarily searched for
information on their own had they wanted to learn, or otherwise did
not recommend the intervention materials for their partners.
Timing of the ETEI
76.2% preferred to receive an educational intervention immediately upon their diagnosis to help them prepare for the
surgery’s challenges and the post-operative period. About 19% of the
study participants, however, preferred to receive the training module
of the intervention following the surgery; they believed that they would
have been too emotionally occupied and overwhelmed beforehand to
be able to properly learn the needed self-care skills (e.g., changing of
stomal appliances and catheters use). Those who agreed that spouses
should have received similar educational materials believed that a
pre-surgical intervention would have been helpful. However, 19.1%
preferred a post-surgical training intervention, as a pre-surgical
training intervention might also raise partners’ anxiety and distress.
Discussion
There is a crucial need for educational and training interventions to
enhance MIBC patients’ treatment decision-making and preparation
for self-care after surgery. Qualitative evaluation of reports of patients
who participated in this study provides evidence for the importance
of such interventions.
Overall, the results of this qualitative study confirm the value
of pre-surgical educational materials for MIBC patients and their
informal caregivers. Nearly all interviewees expressed belief that
they would have made more informed and confident decisions after
receiving detailed information, both literary and visual, about each
surgical intervention’s process, risks, and effects on lifestyle. Those
who believed they would have benefitted also believed that their
spouses or intimate partners would have as well, given their important
caretaking roles.
All participants agreed that receiving the ETEI proposed
information about the types of UD procedures, and their side effects
would have been helpful prior to surgery. Similarly, the vast majority
of patients liked the idea of receiving a prescribed list of questions
to ask during their surgical consultation with the physician. Visual
information depicting different bladder replacement treatments,
stoma appliances, and catheters are perceived as helpful according
to more than four-fifths of patients interviewed. Likewise, more
than four-fifths of patients believed they would have benefitted from
talking to a nurse regarding stoma care, location, and appliances,
regardless of treatment preferences.
Patients with MIBC report significant unmet informational and
supportive care needs; however very few resources are available to meet
these needs [34,36,63,64]. Thus, knowledge of both MIBC treatment
options and their consequences is not only empowering the patient,
but also fundamental to an individual’s decision-making regarding
any issue. Our prior studies in MIBC patients showed that patients
need information about the likelihood of cure, treatment choices, the
benefits and risks of these choices, short- and long-term treatment
side effects, as well as self-care skills associated with these choices to
help them with the treatment decision-making and to prepare for
the unknown [34,36]. Educational tools (e.g., print or Web-based)
can provide a vast amount of information [65,66], however, the
readability of the language exceeds the national average reading ability
[67]. Hence, providing information does not necessarily change the
decision-making process or outcomes. Patients need to integrate
information about treatment options with their personal values and
preferences. When an educational intervention or a patient clinician
discussion regarding treatment decision-making are coupled with a
personally relevant value clarification, the experience can be much
more enhanced for both the patient and the physician [68,69].
According to the US Preventive Services Task Force, a comprehensive
decisional tool should: a) provide adequate information about the
risks, benefits, and limitations of the procedure; b) enhance the
patient’s ability to participate in decision-making with providers at
a personally desired level; and c) help the patient make a decision
that is consistent with his/her personal preferences and values [70].
In line with published data, our studies exploring treatment decisionmaking
in cancer patients showed that patient factors including
age, race, values, and preferences are significantly influential and
should be addressed during decision-making processes [34,36,71].
Promoting insight and prioritizing personal factors along with
medical factors are required in preparation of patients for treatment
decisions. By considering these factors, providers can assist patients
in making informed choices and prepare for the post treatment selfcare
requirements.
Anxiety is a normal and well-documented emotional and
physiological response to anticipating and awaiting major surgery
[72]. While many patients who receive information about their
treatment prior to surgery experience relief, others’ anxiety may
worsen. Our qualitative data also showed that while a large (71.4%)
percentage of patients believed that wearing a stoma bag for 24 h to
48 h would have prepared them for this particular operation’s postsurgical
experience, close to one-third of patients felt that this might
have raised their anxiety levels. However, when asked about the best
time for patients to learn about the skills needed for self-care, equal
number of patients expressed preferences for a pre-surgical hands-on
training versus a post-surgical hands-on training. Justifications for
patients’ preferences of a post-surgical training include reduced stress
associated with a cancer diagnosis and better ability to understand
complicated self-care information at the post-surgical period due
to ongoing coping and adaptation processes. It is therefore very
important to customize educational intervention and provide
resources based on patients’ needs and preferences. Studies in other
cancer populations (e.g., prostate cancer) showed that customizing
educational and decisional tools based on patients’ preferences and
values reduced decisional uncertainty and improved values clarity
[73].
This study suggests that the great majority of patients
recommended that their informal caregivers (e.g., partners and
spouses) receive the same information and training suggested for
MIBC patients. Our prior qualitative research in MIBC patients’
unmet needs [36] showed that many patients relied on family
assistance with self-care, although most of the family care-givers
did not receive formal training for stoma care and catheter use but
rather learned by trial and error and Internet-based resources. Family
caregivers need training in post-operative care before discharge from
the hospital and follow-up during the weeks after surgery. Part of this
education is to provide hands-on training on patient post-surgical
care (e.g., use of stomal appliances and catheters), recognize redflagged
symptoms (e.g., fever, discoloration of stoma, and urinary
blockage), know when to call the medical team to avoid emergency
room visits, and follow-up cancer screening tests. The training
module of the ETEI provides detailed information about these issues
for MIBC patients. Such materials can benefit both the patient and
the family care-givers at multiple levels (e.g., preparation for surgery,
improving self-care skills, and providing online resources for patient
and caregiver support).
Study Limitations
First, study participants were MIBC survivors with close to 50% of participants receiving treatment >1 year before the personal interviews. Including newly diagnosed patients who did not receive treatment yet could provide more timely information about perceived usefulness of the intervention and avoid recall bias. Second, our study participants were recruited from ISMMS and via BCAN website. Majority of participants in our study were Caucasians in relationships (partners/spouses). Thus, our sample might not reflect the general characteristics of the study population. Third, although the study participants suggested that the content of the ETEI is appropriate for both the patient and the informal care-giver, we did not access the care-givers perspective or input on the ETEI content. Examining the care-givers evaluation of the ETEI might reveal other issues and challenges relevant to the care-givers (e.g., care-giving burden, sexuality needs, and social support provision). Additional studies are needed to further explore and confirm the unmet needs of MIBC patients’ informal care-givers to explore their unmet needs and to confirm the appropriateness of the ETEI for the caregivers.
Conclusion
In summary, the study results emphasize the importance of the proposed ETEI and appropriateness of the content of the informational and training modules for both patients and their informal care-givers. The next step of our research (ongoing study) is to examine the feasibility and efficacy of implementing the ETEI in traditional clinic setting to enhance both treatment decisions and skills needed for post-surgical care in both patients and their caregivers. Such study will guide further improvement of the content, delivery method, and evaluation of the ETEI (i.e., in person session versus Web-based interventions).
Practice Implications
Educational and training information in the form of adequate counseling, information booklets and pictorials regarding treatment options, and training for self-care would enable patients to make informed decisions. This could potentially mean an increased need for resources – educational booklets, audio-visuals, trained health care personnel, length +/- number of appointments.
Acknowledgement
This work was supported by mentored research scholar grants from the American Cancer Society (121193-MRSG-11-103-01- CPPB) and the National Cancer Institute (1R03CA165768-01A1).
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