Pancreas CancerSURGIMEDIANCT07494994
SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent
A study testing Standard Informed Consent and Multimedia Video - Based Informed Consent in people with Pancreas Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Informed consent is an ethical and legal component of the pre-procedural process. Informed consent involves the explanation of procedural steps and discussion regarding the risks, benefits, and alternatives of the proposed procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Standard Informed Consent and Multimedia Video - Based Informed Consent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 If a participant becomes pregnant during the study, they will be withdrawn and replaced with a new participant if resources allow.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Mia A MacDonald, MD, 919-984-0000, Mia.MacDonald@unchealth.unc.edu
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About this study
Informed consent is an ethical and legal component of the pre-procedural process. Informed consent involves the explanation of procedural steps and discussion regarding the risks, benefits, and alternatives of the proposed procedure. The current informed consent process lacks standardization, and patient experience can vary widely depending on the provider obtaining consent. This pilot study aims to ensure high quality informed consent for patients undergoing a complex oncologic operation known as a pancreaticoduodenectomy (Whipple operation), through the creation of an educational video as a method of obtaining informed consent. This study will explore whether the application of an educational video as part of the informed consent process increases patient understanding, comfort, and overall satisfaction throughout the Whipple operative course. The primary objective of this study is to determine whether implementation of a multimedia video as an enhancement to surgical informed consent improves patient satisfaction, promotes understanding, and informs operative expectations. The desired outcome is to standardize the informed consent process to eliminate variability in the quality of the consent process and to mitigate the impact of healthcare barriers such as health literacy and language proficiency in the informed consent process.
- Conditions
- Pancreas Cancer
- Being tested
- Standard Informed Consent, Multimedia Video - Based Informed Consent
- Keywords
- informed consent, pancreaticoduodenectomy, Whipple operation, educational video, complex surgical operation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Informed ConsentBehavioural
Participants receive the institution's standard verbal informed consent discussion delivered by a qualified provider, covering the Whipple operation, expected outcomes, risks, benefits, and alternatives. The provider answers follow-up questions.
Multimedia Video - Based Informed ConsentBehavioural
Participants view a narrated, animated video explaining the Whipple procedure; benefits, alternatives, and potential perioperative and postoperative complications; and resources for recovery. Afterward, a provider answers questions.
| Study group | Role | What they receive |
|---|---|---|
| Standard Informed Consent | Active comparator | 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. Receives: Behavioral: Standard Informed Consent |
| Multimedia Video-Enhanced Informed Consent | Experimental | 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. Receives: Behavioral: Multimedia Video - Based Informed Consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comprehension of the intervention
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.
Measured: Baseline and up to 4 weeks after surgery
Patient Satisfaction of the Intervention
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.
Measured: Baseline and up to 4 weeks after surgery
Secondary outcomes (3)
Patient Preference for Consent Modality
Assesses pancreatoduodenectomy patients' preferred informed consent method (multimedia video vs. standard verbal consent) and how these preferences change over the perioperative period. Questionnaire items will capture preferred modality and factors influencing preference.
Patient preferences will be assessed using Satisfaction questions 10-11 systems survey (2 point Likert scale questionnaire) Minimum score 0 and maximum score 10
Measured: Baseline and up to 4 weeks after surgery
Length of Stay, Readmission, and Complications
Evaluates whether use of a multimedia video for informed consent affects postoperative clinical outcomes among pancreatoduodenectomy patients.
Measurement: Data collected will include: Length of hospital stay (LOS) in days, 30 day readmission (yes/no and reason) and postoperative complications, including type and severity (as recorded in clinical documentation). Outcomes will be compared between the multimedia video group and the standard informed consent group. Readmission and complications will be obtained by electronic medical record abstraction.
Measured: From surgery through 30 days post discharge
Number of Patient Initiated MyChart Messages
Determines whether the multimedia informed consent video impacts postoperative communication needs by measuring patient initiated electronic messages sent to providers.
Measurement: Total number of MyChart messages sent by each participant (question based or concern based) will be extracted from the electronic health record and compared between study arms.
Measured: From surgical consent through first postoperative outpatient follow up (≈3-4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jen J Yeh, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494994
- Sponsor's protocol ID
- LCCC2535
- Acronym
- SURGIMEDIA
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent
- ClinicalTrials.gov ID
- NCT07494994
- Acronym / sponsor ID
- SURGIMEDIA / LCCC2535
- Conditions
- Pancreas Cancer
- Keywords
- informed consent, pancreaticoduodenectomy, Whipple operation, educational video, complex surgical operation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Informed consent is an ethical and legal component of the pre-procedural process. Informed consent involves the explanation of procedural steps and discussion regarding the risks, benefits, and alternatives of the proposed procedure. The current informed consent process lacks standardization, and patient experience can vary widely depending on the provider obtaining consent. This pilot study aims to ensure high quality informed consent for patients undergoing a complex oncologic operation known as a pancreaticoduodenectomy (Whipple operation), through the creation of an educational video as a method of obtaining informed consent. This study will explore whether the application of an educational video as part of the informed consent process increases patient understanding, comfort, and overall satisfaction throughout the Whipple operative course. The primary objective of this study is to determine whether implementation of a multimedia video as an enhancement to surgical informed consent improves patient satisfaction, promotes understanding, and informs operative expectations. The desired outcome is to standardize the informed consent process to eliminate variability in the quality of the consent process and to mitigate the impact of healthcare barriers such as health literacy and language proficiency in the informed consent process.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Informed Consent | Active comparator | Behavioral: Standard Informed ConsentParticipants 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. |
| Multimedia Video-Enhanced Informed Consent | Experimental | Behavioral: Multimedia Video - Based Informed ConsentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Informed ConsentParticipants receive the institution's standard verbal informed consent discussion delivered by a qualified provider, covering the Whipple operation, expected outcomes, risks, benefits, and alternatives. The provider answers follow-up questions. | Behavioural | Standard Informed Consent |
| Multimedia Video - Based Informed ConsentParticipants view a narrated, animated video explaining the Whipple procedure; benefits, alternatives, and potential perioperative and postoperative complications; and resources for recovery. Afterward, a provider answers questions. | Behavioural | Multimedia Video-Enhanced Informed Consent |
Primary outcome
Patient comprehension of the intervention
Time frame: Baseline 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 Intervention
Time frame: Baseline 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.
3 secondary outcomes
Patient Preference for Consent Modality
Time frame: Baseline and up to 4 weeks after surgery
Length of Stay, Readmission, and Complications
Time frame: From surgery through 30 days post discharge
Number of Patient Initiated MyChart Messages
Time frame: From surgical consent through first postoperative outpatient follow up (≈3-4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jen J Yeh, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Informed Consent and Multimedia Video - Based Informed Consent in people with Pancreas Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mia A MacDonald (919-984-0000, Mia_MacDonald@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comprehension of the intervention (time frame: Baseline and up to 4 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.