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SURGIMEDIA: Improving Consent for Pancreas Cancer Surgery

This study, called SURGIMEDIA, is looking at ways to improve how patients understand and are satisfied with the informed consent process for a complex surgery called a Whipple operation (pancreaticoduodenectomy) for pancreas cancer. Researchers are comparing two ways of getting consent: the standard verbal discussion you would normally have with your doctor, and a new method using a narrated, animated video that explains the procedure, its benefits, risks, and recovery. The study aims to enroll 60 participants and will measure how well patients understand the information and how satisfied they are with the consent process, both before and up to four weeks after surgery. To join, you must be at least 18 years old and willing to follow study procedures. The current status of this study is unclear.

Study design
This study plans to enroll 60 participants to compare two different ways of providing informed consent: standard verbal discussion versus a multimedia video. It is an interventional study, meaning participants will receive one of these two approaches.
What's involved
You would receive either a standard verbal informed consent discussion or watch a multimedia video for informed consent. Your understanding and satisfaction would be measured at the start of the study and up to four weeks after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up to 4 weeks after surgery to assess comprehension and satisfaction.

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NCT07494994

SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent

Not Yet Recruiting
NAAges 18+Interventional
UNC Lineberger Comprehensive Cancer Center
~60 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Standard Informed ConsentMultimedia Video - Based Informed Consent

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient comprehension of the intervention
Measured over Baseline and up to 4 weeks after surgery
+1 more outcome measured

Conditions

Pancreas Cancer

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Jen J Yeh, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Mia A MacDonald
[email protected]
919-984-0000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
Age ≥ 18 years at the time of informed consent for study participation.
Scheduled to undergo a standard of care pancreaticoduodenectomy procedure.
English as the patient's self-reported preferred language.

Exclusion

Inability to speak English.
Dementia altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent as determined by the study physician.
Currently pregnant. If a participant becomes pregnant during the study, they will be withdrawn and replaced with a new participant if resources allow.

What this trial measures

  • Patient comprehension of the interventionBaseline and up to 4 weeks after surgery

    This outcome evaluates whether implementation of a multimedia video for informed consent improves patient comprehension of the pancreatoduodenectomy (Whipple) procedure, and clarity of operative expectations. These domains will be assessed using validated questionnaires administered at three time points: preoperative: Immediately after surgical consent, postoperative (inpatient): During postoperative hospitalization and postoperative (outpatient): At first follow-up visit (approximately 3-4 weeks after surgery). Patient responses across these time points will be compared between the multimedia video group and the standard informed consent group. Patient satisfaction will be measured using patient understanding and communication module of the PSQ-3 (Patient Satisfaction Questionnaire-III), a 5-item survey scored on a 5-point Likert scale (Strongly Agree → Strongly Disagree). Total scores range from 0 to 15, with higher scores indicating greater dissatisfaction.

  • Patient Satisfaction of the InterventionBaseline and up to 4 weeks after surgery

    This outcome evaluates whether implementation of a multimedia video for informed consent improves patient satisfaction, comprehension of the pancreatoduodenectomy (Whipple) procedure, and clarity of operative expectations. These domains will be assessed using validated questionnaires administered at three time points: preoperative: Immediately after surgical consent, postoperative (inpatient): During postoperative hospitalization and postoperative (outpatient): At first follow-up visit (approximately 3-4 weeks after surgery). Patient responses across these time points will be compared between the multimedia video group and the standard informed consent group. Patient satisfaction will be measured using satisfaction module of PSQ-3 (Patient Satisfaction Questionnaire-III), a 8-item survey scored on a 5-point Likert scale (Strongly Agree → Strongly Disagree). Total scores range from 0 to 40, with higher scores indicating greater dissatisfaction.