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Trial registered on ANZCTR


Registration number
ACTRN12616000288426
Ethics application status
Approved
Date submitted
21/12/2015
Date registered
4/03/2016
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Date results information initially provided
4/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Written information delivery to improve patient understanding and anxiety at Flexible cystoscopy
Scientific title
Written vs standard information delivery at Flexible cystoscopy - impact on patient understanding and anxiety
Secondary ID [1] 288197 0
Nil known
Universal Trial Number (UTN)
U1111-1177-9150
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial carcinoma 297105 0
Haematuria 297106 0
Voiding symptoms 297107 0
Condition category
Condition code
Renal and Urogenital 297343 297343 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Written information on standardised proforma (outlining findings at cystoscopy and planned management specific to the patient) added to standard verbal information given immediately after flexible cystoscopy
Intervention code [1] 293501 0
Treatment: Other
Intervention code [2] 294105 0
Behaviour
Comparator / control treatment
Standard verbal information (outlining findings at cystoscopy and planned further management) given at immediately after completion of flexible cystoscopy
Control group
Active

Outcomes
Primary outcome [1] 296902 0
Understanding of information given - patient asked to write in free text the findings of cystoscopy and proposed management plan. Comparison to findings and plan as recorded by proceduralist, with scoring as 0 (inaccurate), 1 (partially concordant) and 2 (accurate and concordant)
Timepoint [1] 296902 0
Immediately after procedure (10-30min)
Secondary outcome [1] 319665 0
Self-reported anxiety level on a 5-point Likert scale
Timepoint [1] 319665 0
Immediately after procedure (10-30 min)
Secondary outcome [2] 319666 0
Self-reported feeling of being adequately informed on a 5-point Likert scale
Timepoint [2] 319666 0
Immediately after procedure (10-30min)

Eligibility
Key inclusion criteria
Any patient undergoing flexible cystoscopy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive or language barrier to assessments

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292592 0
Self funded/Unfunded
Name [1] 292592 0
N/A
Address [1] 292592 0
N/A
Country [1] 292592 0
Primary sponsor type
Hospital
Name
Austin health
Address
147 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 291312 0
None
Name [1] 291312 0
Address [1] 291312 0
Country [1] 291312 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294075 0
Austin Health HREC
Ethics committee address [1] 294075 0
Austin Health
147 Studley Road
Heidelberg 3084
Victoria
Ethics committee country [1] 294075 0
Australia
Date submitted for ethics approval [1] 294075 0
Approval date [1] 294075 0
24/04/2013
Ethics approval number [1] 294075 0
H2013/05050

Summary
Brief summary
Background and rationale: Patients undergoing procedures such as flexible cystoscopy are usually given information regarding the findings from the procedure, and further treatment plans. This may be done verbally (as is usual at Austin Health) or in writing (as is done in some centres). We hypothesise that the provision of written information will aid patient understanding and retention, and thereby reduce anxiety.

Methodology: Patients undergoing flexible cystoscopy will be invited to participate, with the main exclusion being those with language, psychological or cognitive barriers to participation. Patients will be given a plain (English) language statement, and will sign the study consent form, and complete the pre-procedure questionnaire. They will then have their flexible cystoscopy as is usual practice. The findings from the cystoscopy as well as the plan of management will be communicated to them either verbally only or on a standardized written template in addition, according to a random allocation. At the conclusion of the procedure, the patient will be invited to complete the post-procedure questionnaire.

Data collection and analysis: The questionnaires and limited clinical and demographic data will be collected in blinded fashion by members of the research team other than the proceduralists (p). Data from the medical record to be collected in de-identified fashion includes age, sex, diagnosis (ie bladder cancer, other pathology or normal), prior cystoscopies (& number) and need for further intervention (after cystoscopy).

Endpoints: The patient’s understanding of the findings at cystoscopy and the subsequent plan will be coded as follows:
*Good: patient’s response matches documentation from proceduralist
*Fair: patient’s response is close to documentation from proceduralist, but with minor errors / discrepancies
*Poor: No response or response completely erroneous
The patients’ self-assessed impression of being well informed and worried will be scored on a standard 5-point scale.

The above measures will be compared between the two groups receiving verbal vs written information, with assessment of associations with other variables (i.e. age, sex, diagnosis, prior cystoscopies and need for subsequent procedures)

Significance: On the basis of this study, we will determine the preferred method for communicating with patients after flexible cystoscopy. The findings may have relevance for patient communication after day-case surgical procedures in general.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62338 0
A/Prof Shomik Sengupta
Address 62338 0
Austin Health, Dept of Urology
Studley Road
Heidelberg, Vic 3084
Country 62338 0
Australia
Phone 62338 0
+61394965000
Fax 62338 0
Email 62338 0
senguptaurology@gmail.com
Contact person for public queries
Name 62339 0
A/Prof Shomik Sengupta
Address 62339 0
Austin Health, Dept of Urology
Studley Road
Heidelberg, Vic 3084
Country 62339 0
Australia
Phone 62339 0
+61394965000
Fax 62339 0
Email 62339 0
senguptaurology@gmail.com
Contact person for scientific queries
Name 62340 0
A/Prof Shomik Sengupta
Address 62340 0
Austin Health, Dept of Urology
Studley Road
Heidelberg, Vic 3084
Country 62340 0
Australia
Phone 62340 0
+61394965000
Fax 62340 0
Email 62340 0
senguptaurology@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1492 0
https://link.springer.com/article/10.1007%2Fs00345-018-2233-7
Attachments [1] 1492 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary