Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03325231 |
Other study ID # |
RIO 018-17 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 20, 2017 |
Est. completion date |
September 30, 2021 |
Study information
Verified date |
October 2022 |
Source |
Swansea University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Radical cystectomy (bladder removal) after bladder cancer necessitates surgical
reconstruction to allow urine drainage. Usually, this is achieved by either ileal conduit (a
stoma leads to an external bag) or orthotopic neobladder (the creation of an artificial
internal bladder). These treatments are most successful when tailored to the patient's own
lifestyle needs. The current project will explore patient concerns, and the aspects of their
lifestyles and values, that influence their choice of bladder reconstruction. It will also
examine which of these concerns and values best predict satisfaction and enhanced QoL,
following bladder reconstruction. Participants will be recruited from Health Board databases
of those who have had advanced bladder cancer (grade pT1 and above) and undergone either IC
or NB procedures within the last five years. 40 participants (equal numbers with each
surgical procedure) will be randomly selected from the patient databases. They will be
interviewed by a Researcher and a Clinical Nurse Specialist. A semi-structured interview will
be conducted to ascertain patients' views about the key factors influencing their treatment
decision and their satisfaction with the outcome. Approximately 200 participants (equal
numbers with IC and NB) will be sent three questionnaires to assess their life values, QoL,
and satisfaction with treatment: (1) Bladder Reconstruction Satisfaction Questionnaire
measuring levels of satisfaction with bladder reconstruction; (2) EORTC QLQ-C30 measuring QoL
in areas relevant to cancer patients; and (3) Life Values Inventory measuring values and
lifestyles important to patients. Participants will be asked to complete the questionnaires
and return them using a prepaid envelope. Participants will be provided with the contact
details of a Clinical Nurse Specialist known to them to contact if they require help
completing the questionnaires.
Description:
Aims and Objectives. The proposed research aims: firstly, to enhance our understanding of
patient concerns, lifestyles, and values, that influence their choice of bladder
reconstruction and predict their treatment satisfaction and quality of life (QoL); and,
secondly, to initiate the development a novel decision-aid tool to help bladder-cancer
patients, their families, and medical/health professionals to choose the reconstructive
surgery following bladder removal that best suits a patient's needs. To these ends, a
complementary combination of qualitative and quantitative research approaches will be
employed to obtain information from patients about the reasons for their reconstructive
surgery choices, the aspects of their lifestyle that were most important to them in reaching
their decisions, and the degree to which they are satisfied with their reconstruction. These
findings will be used to inform the items to be contained in a pilot joint decision-making
tool to support patients and medical professionals when planning such life-changing surgery.
Such a tool ultimately could support patient choice, enhance QoL, and influence
decision-making practice. Thus, the specific objectives of the research will be to: (1)
identify the factors important for patients when choosing a bladder reconstruction; (2)
establish the degree to which these factors predict satisfaction with the reconstruction;
and, ultimately, (3) start to develop a joint decision-aid tool for patients and medical
staff, to use when deciding on the choice of diversionary procedure, that highlights these
key factors predicting success and better QoL following different forms of bladder
reconstruction.
Methodology and Project Plan. Participants Participants will be recruited from Health Board
databases of those who have had advanced bladder cancer (grade pT1 and above) and undergone
either IC or NB procedures within the last five years. Around 40 patients per year are
referred to the ABMU; this is in line with expectations, given the size of the ABMU patient
population (600,000) and rates of bladder cancer, giving a potential sample of 200 patients
over the previous five years. This will provide an adequate population from which to sample
participants. No form of payment will be offered for participation, but participants will be
reimbursed for travel expenses. There will be no other inclusion or exclusion criteria in
order to access a wide range of patients with potentially different values and lifestyles,
and to aid in the recruitment of adequate sample sizes.
Qualitative Study Forty participants (equal numbers with each surgical procedure) will be
randomly selected from the patient databases and invited for interview. This number is
achievable given the size of the database, and exceeds the usual criteria (12-18; Guest et
al., 2006) for saturation in qualitative research, even with expectation of some
non-participation.
The participants will be interviewed by a Researcher and a Clinical Nurse Specialist in a
quiet room in the Clinical Research Unit of the Hospital. A semi-structured interview format
will be adopted to allow participants latitude in expressing issues that are important to
them, and without forcing particular issues. The same semi-structured interview script will
be used for each participant, ensuring all are asked the same questions. The general themes
to be asked about will be: Who patients consulted and discussed options with; What types of
information, support, and advice were they offered; What were the attributes or aspects of
the NB/IC that influenced their choice; Which aspects of their lifestyle were most important
in making a decision; What factors could have been considered that were not; What types of
help have they been offered since; Could they have been offered other information at the
time; How do they feel their choice influences their life today; Are they satisfied with
their decision. These questions will allow a wide range of patient needs, values, and
experiences to be elicited.
Transcribed interview recordings will be subjected to thematic content analysis, in line with
previous recommendations (Vaughn et al., 1996), and accepted procedures in health contexts
(Osborne et al., 2012a; 2012b; Osborne & Reed, 2008). Transcripts will be examined
independently by two Researchers to identify key themes and ensure reliability. Individual
'units of information' contained within each transcript will be highlighted (a 'unit' is any
piece of text that relates to an identified theme, and that can be interpreted on its own to
provide a meaningful and informative comment). From reading the unitised comments, the
initial themes will be refined, so that all 'units of information' can be categorised
according to those themes. Coding of 'units' into themes will be conducted independently by
two Researchers, and Cohen's Kappa will be used to establish reliability.
Quantitative Study One hundred participants (equal numbers with IC and NB) will be randomly
selected from the Health Board database, as described above. The numbers in the database
(200) will allow recruitment of these participants, and, assuming a 50% non-return rate, this
will allow sufficient power for subsequent analyses. G-Power calculations suggest that, to
identify a moderate relationship (r = .3) with 85% power, a sample size of 90 will be needed.
If recruitment appears to be low, then other health boards (in particular, Newcastle with
whom Mr. Younis is currently employed) will be approached.
Participants will be asked to complete three questionnaires and to return them using a
prepaid envelope. Participants will be provided with contact details of a Clinical Nurse
Specialist known to them if they require help completing three questionnaires: Bladder
Reconstruction Satisfaction Questionnaire measures levels of satisfaction with bladder
reconstruction, the relative ease of adapting to the new bladder, and specific aspects
patients are happy or unhappy with regarding their procedure; EORTC QLQ-30 (Aaronson et al.,
1993) assesses QoL aspects relevant to cancer patients concerning: physical functioning; role
functioning; emotional functioning; cognitive functioning; social functioning; and global
health status. This questionnaire is reliable and has been used by a large number of
researchers (Mystakidou et al., 2001); The Life Values Inventory (Crace & Brown, 1996)
measures values across: achievement, belonging, concern for the environment, concern for
others, creativity, financial prosperity, health and activity, humility, independence,
loyalty to family or group, privacy, responsibility, scientific understanding, and
spirituality. The internal reliability is high (Cheng & Fleischmann, 2010).
The values identified will be related by regression analyses to QoL and satisfaction in order
to identify whether there are different predictors of outcome for different forms of bladder
reconstruction.
Pilot Tool Development Converging themes emerging from the two studies in terms of predicting
satisfaction with IC and NB will be drawn together, and a decision-aid tool will be produced
for future study. The items identified for inclusion in the tool will be sent to a range of
health professionals involved in delivery of surgery and physiotherapy (consultant surgeons,
registrars, clinical nurse specialists, and past patients) to obtain their views on its face
validity. Items that are rated as inappropriate or redundant will be re-assessed and
potentially excluded from the tool, and any missing areas of importance identified by the
expert panel will be re-examined.