Multimedia Informed Consent for Pancreatic Cancer Surgery
(SURGIMEDIA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to help patients understand and feel comfortable with a complex surgery for pancreatic cancer called a Whipple operation. Instead of only speaking with a doctor, patients will watch an educational video (Multimedia Video-Based Informed Consent) that explains the surgery, its risks, and what to expect before and after. The trial aims to determine if this video makes patients feel more informed and satisfied with their decision. It seeks participants who are scheduled for this surgery and speak English. As an unphased trial, this study offers a unique opportunity to enhance understanding and comfort with the surgery through innovative educational methods.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this multimedia video-based informed consent is safe for patients undergoing pancreatic cancer surgery?
Research has shown that using videos to explain medical procedures is safe and well-received by patients. In one study, 90% of patients reported that the video answered their questions about surgery as well as or better than their doctor did. This indicates that patients are comfortable using videos as part of the informed consent process, and it does not cause harm.
No reports have indicated negative effects from using educational videos for informed consent. These videos aim to simplify complex medical information, helping patients feel more informed and confident about their surgery. While researchers continue to study how well this approach improves patient understanding and satisfaction, it is generally seen as a safe and helpful tool.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel approach to informed consent for pancreatic cancer surgery. Unlike the traditional process where a healthcare provider verbally explains the procedure, the multimedia video-enhanced informed consent uses animated videos to break down complex information into simple, non-technical language. This method aims to improve patient understanding of the Whipple procedure, including its steps, benefits, and potential risks, by presenting information in a more engaging and accessible format. By potentially enhancing comprehension, this approach could lead to better-informed patients and more meaningful consent.
What evidence suggests that this multimedia video-based informed consent is effective for improving patient understanding and satisfaction in pancreatic cancer surgery?
Research has shown that videos explaining surgeries can help patients understand and feel more comfortable about their operations. In this trial, participants will either undergo the standard informed consent process or view a multimedia, animated educational video as part of the informed consent for the Whipple operation for pancreatic cancer. Other studies have found that patients who watched educational videos before surgery felt more informed and satisfied. These videos explain the steps of a procedure in easy-to-understand language. This method ensures all patients receive the same information, reducing confusion and anxiety. Video-based education also aids individuals with varying levels of health knowledge, making it easier for everyone to give informed consent.12367
Who Is on the Research Team?
Jen J Yeh, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) who speak English and are scheduled to have a Whipple surgery for pancreatic cancer. Participants must be able to understand the study, give consent, and follow procedures. People with dementia, certain psychiatric conditions, or who are pregnant cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Informed Consent Process
Participants undergo the informed consent process, either through standard verbal consent or multimedia video-enhanced consent
Surgery and Immediate Postoperative Care
Participants undergo the Whipple procedure and receive immediate postoperative care
Follow-up
Participants are monitored for safety and effectiveness after surgery, including assessment of patient satisfaction and comprehension
What Are the Treatments Tested in This Trial?
Interventions
- Multimedia Video-Based Informed Consent
Trial Overview
The study compares two ways of getting surgical consent: the usual discussion versus an educational video plus standard consent. It aims to see if using a video helps patients better understand their surgery and feel more satisfied with the process.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants view a multimedia, animated educational video that explains major steps of the Whipple procedure, benefits, alternatives, and peri-/post-operative concerns using simple, non-technical language. After viewing, a consenting provider is available to answer questions. Participants complete pre- and post-intervention surveys and are audio recorded during the consent process.
Participants receive the current standard-of-care informed consent process for Whipple surgery. A consenting provider presents the procedure, risks, benefits, and alternatives, and is available to answer questions. Participants complete pre- and post-intervention surveys and are audio recorded during the consent process.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
Citations
Impact of video-assisted preoperative patient information on ...
The INFORM trial will be the first trial to investigate preoperative video-assisted preoperative patient information on patient-reported and ...
Multimedia Informed Consent for Pancreatic Cancer ...
The primary objective of this study is to determine whether implementation of a multimedia video as an enhancement to surgical informed consent ...
Online video versus face-to-face patient–surgeon consultation
This systematic review identified some benefits of OVC such as shorter waiting and total appointment times as compared to F2F patient–surgeon consultation.
Impact of video-assisted preoperative patient information ...
The aim of the INFORM trial is to evaluate the impact of video-assisted preoperative patient information on patient-reported and surgical ...
Multimedia in preoperative patient education for adults ...
The current study aims to examine the effect of preoperative multimedia education on postoperative outcomes of adult patients undergoing surgery for cancer.
6.
cancernetwork.com
cancernetwork.com/view/the-intricacy-of-the-robotic-whipple-surgery-a-conversation-with-a-surgeonThe Intricacy of the Robotic Whipple Surgery
We have now performed over 80 robotic Whipple procedures with favorable outcomes. Our postoperative complications, mainly pancreatic fistula or ...
7.
journals.lww.com
journals.lww.com/international-journal-of-surgery/fulltext/2025/03000/virtual_3d_models,_augmented_reality_systems_and.26.aspxVirtual 3D models, augmented reality systems and virtual...
Augmented reality systems may improve pancreatic surgery outcomes by optimizing the identification of resection lines and healthy anatomical structures.
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