Trial Review

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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 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
Sex
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
1/05/2013
Date of last participant enrolment
Anticipated
Actual
28/09/2013
Date of last data collection
Anticipated
Actual
31/10/2013
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292592 0
Self funded/Unfunded
Name [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
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
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
[email protected]
Contact person for public queries
Name 62339 0
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
[email protected]
Contact person for scientific queries
Name 62340 0
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
[email protected]

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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.