Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000644561
Ethics application status
Approved
Date submitted
7/01/2024
Date registered
20/05/2024
Date last updated
20/05/2024
Date data sharing statement initially provided
20/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing animation-based with written patient information for educating patients about robotic-assisted radical prostatectomy
Scientific title
A randomised controlled trial comparing animation-based with written patient information for educating patients about robotic-assisted radical prostatectomy
Secondary ID [1] 311270 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 332494 0
Condition category
Condition code
Cancer 329187 329187 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Half of the study participants will be allocated to the intervention group. This group will view a newly developed audiovisual consent animation for robotic assisted radical prostatectomy based on the information included in the control group pamphlet and legal consent requirements . The animation underwent a process of peer review by urologists, urology clinical nurse consultants, and patients at the Royal Prince Alfred Institute of Academic Surgery. The 10 minute video is structured into the sections “about the prostate”, “reasons for prostatectomy”, “the procedure”, “preparing for the procedure”, “benefits of the procedure”, “risks of not having the procedure”, “alternatives to the procedure”, “risks of the procedure”, “patients at increased risk of complications” and “conclusion”. The intervention will be delivered online via REDCap link. The number of views will be unlimited, replicating real-world setting where patients can spend as much or as little time with the information as desired. Data regarding number of views will not be monitored.
Intervention code [1] 327722 0
Treatment: Other
Comparator / control treatment
The other half of study participants will be allocated to a control group and will receive a written information pamphlet. The written information is adapted from The British Association of Urological Surgeons Information for Robotic-Assisted Laparoscopic Radical Prostatectomy. This 9-page pamphlet is considered to be a good-quality resource for patients and is often given to patients considering a robotic-assisted laparoscopic prostatectomy outside of the research setting. It takes approximately 10-15 minutes to read. All patients will be given this pamphlet via an online REDCap link. This pamphlet is part of standard care. Time spent with the pamphlet or number of reads will be unlimited and will not be monitored in the trial, replicating real-world setting where patients can spend as much or as little time with the information as desired.
Control group
Active

Outcomes
Primary outcome [1] 337029 0
The first primary outcome is the difference in knowledge attainment between the two groups.
Timepoint [1] 337029 0
Knowledge attainment will be assessed the day of viewing the informative materials
Primary outcome [2] 337030 0
The second primary outcome is the difference in knowledge retention between the two groups.
Timepoint [2] 337030 0
Repeating the knowledge questionnaire immediately after viewing the information materials, and 5 days later.
Secondary outcome [1] 430435 0
The first secondary outcome is the difference in the mean change in anxiety levels from baseline after using the informative materials between groups.
Timepoint [1] 430435 0
Immediately after using the information materials, and 5 days later
Secondary outcome [2] 430436 0
The second secondary outcome is the difference in mean satisfaction scores between groups.
Timepoint [2] 430436 0
At the time of using the information materials
Secondary outcome [3] 430437 0
The tertiary outcome of this study is the identification of areas for improvement and patient preferences in the provision of information about the RARP procedure.
Timepoint [3] 430437 0
2 weeks post prostacteomy

Eligibility
Key inclusion criteria
1. Diagnosed prostate cancer
2. Consented for RARP by their treating surgeon
3. Able to read and speak English
4. Willingness and capacity to provide informed consent
5. Willingness to participate and comply with the study requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Insufficient English language comprehension, as indicated by a translator requirement during consultations.
2. Hearing or visual impairment
3. Lacks the capacity to consent to participation

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)
Central randomisation through REDCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
REDCap stratified randomisation module, using a pre-generated permuted block randomisation list
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Knowledge attainment will be determined by a comparison of mean scores in the initial bespoke knowledge questionnaire between the two groups.

The mean difference in initial and day 5 scores will be compared between the two groups to measure knowledge retention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/06/2024
Actual
Date of last participant enrolment
Anticipated
12/10/2024
Actual
Date of last data collection
Anticipated
14/11/2024
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315527 0
Self funded/Unfunded
Name [1] 315527 0
In-kind support by study investigators Dr Rebecca Saunderson Dr Brayden March, Dr Arthur Vasilaras, A/Prof Paul Sved, Dr Nariman Ahmandi, Prof Henry Woo, A/Prof Niuban Thanigasalam, Dr Richard Haddad, Dr Andre Lalak, Dr Zoe Williams
Country [1] 315527 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
City Rd, Darlington, New South Wales 2006
Country
Australia
Secondary sponsor category [1] 317611 0
None
Name [1] 317611 0
Address [1] 317611 0
Country [1] 317611 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314427 0
Sydney Local Health District (RPA Zone) Ethics Review Committee
Ethics committee address [1] 314427 0
Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [1] 314427 0
Australia
Date submitted for ethics approval [1] 314427 0
14/06/2022
Approval date [1] 314427 0
17/06/2022
Ethics approval number [1] 314427 0

Summary
Brief summary
This study aims to explore whether an audiovisual medium is more effective than written information for patients seeking information necessary for informed consent for robotic-assisted radical prostatectomy (RARP).

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with prostate cancer and you have been scheduled to undergo a robotic-assisted radical prostatectomy.

Study details
All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants allocated to the first group will be asked to watch a 10 minute animated video about the robotic-assisted prostatectomy procedure prior to answering questions about the procedure and the consent process.

Participants allocated to the second group will be asked to read an information pamphlet about the robotic-assisted radical prostatectomy via a website prior to answering questions about the procedure and the consent process.

It is hoped this research will determine whether presenting prostate cancer patients with audio-visual information about a complex surgical procedure allows patients to develop a greater understanding of the procedure compared to traditional written pamphlets.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131542 0
Dr Scott Leslie
Address 131542 0
Michael Spence Building, Corner of Eastern Avenue and City Rd, The University of Sydney, Camperdown, NSW 2050
Country 131542 0
Australia
Phone 131542 0
+61 437838289
Fax 131542 0
Email 131542 0
[email protected]
Contact person for public queries
Name 131543 0
Zoe Williams
Address 131543 0
Nepean Hospital Department of Urology, Derby Street, Nepean Hospital, Kingswood, NSW 2747
Country 131543 0
Australia
Phone 131543 0
+61 411951001
Fax 131543 0
Email 131543 0
[email protected]
Contact person for scientific queries
Name 131544 0
Zoe Williams
Address 131544 0
Nepean Hospital Department of Urology, Derby Street, Nepean Hospital, Kingswood, NSW 2747
Country 131544 0
Australia
Phone 131544 0
+61 411951001
Fax 131544 0
Email 131544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.