None listed
Conditions
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.
Interventions
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 s
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.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Primary purpose
Educational / counselling / training
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed