WashU DIEP Flap Video and Patient Understanding Improvement

November 18, 2025 updated by: Washington University School of Medicine

Patients will complete a survey before and after watching the WashU DIEP Flap Video at their pre-operative standard of care visit, and a third survey at their post-operative standard of care visit. These surveys will use questions from SILS, APAIS, PEMAT, and AIM/IAM to assess the patient's health literacy, demographics questions, and questions concerning patient understanding and anxiety surrounding the procedure. The purpose of the post-op survey will be to assess how well the video set expectations of the procedure and recovery process and will repeat questions asked pre-operatively. Survey responses will be analyzed to determine if there are beneficial trends and improvement in patient understanding and anxiety due to adjunct video usage.

Primary Objective: The primary aim of the study is to determine if our animated video affects understanding and anxiety survey scores in patients undergoing DIEP breast reconstruction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Justin M Sacks, M.D., MBA, FACS
  • Phone Number: 314-362-7388
  • Email: jmsacks@wustl.edu

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Justin M Sacks, M.D., MBA, FACS
          • Phone Number: 314-362-7388
          • Email: jmsacks@wustl.edu
        • Principal Investigator:
          • Justin M Sacks, M.D., MBA, FACS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Scheduled to have DIEP-flap breast reconstruction at Barnes Jewish Hospital
  • Speak English
  • ≥ 18 years of age

Exclusion Criteria:

  • Non-English speaking are excluded as the consent, questionnaires, and video are only available in English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WashU DIEP Flap Video
At the pre-operative appointment, patients will complete the pre-video survey (~10min) via RedCap, watch the video (~5min), and complete the post-video survey (~10min) via RedCap. During the standard of care follow-up appointment ≤ 30 days after surgery, consented patients will fill out a third survey via RedCap (~5min).
Other: WashU DIEP Flap Video
Video uses visual cues and graphics to help explain complex procedures in a simplified, comprehensible fashion to patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in understanding as measured by the Comprehension Assessment
Time Frame: Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)
The pre-op, pre-video survey includes a 10-question comprehension assessment. The pre-op, post-video survey repeats the comprehension assessment. Scores of the comprehension assessment will be compared before and after video watching per patient to determine change in understanding due to the video. It will be scored on a 10-point scale based on correct answers with a higher score meaning greater understanding of the procedure.
Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)
Change in anxiety as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time Frame: Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)
Scores of the APAIS will be compared before and after video watching per patient to determine change in anxiety due to the video. Scoring of APAIS will be per the literature (6-30 with higher score meaning greater anxiety).
Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriate expectation setting as measured by The Patient Education Materials Assessment Tool (PEMAT)
Time Frame: Before video at pre-operative visit and at post-operative visit (estimated to be 3 months)
Will be used to assess video quality. Validated scoring will be used (0-12 with higher score meaning better quality).
Before video at pre-operative visit and at post-operative visit (estimated to be 3 months)
Appropriate expectation setting as measured by the Acceptability of Intervention Measure (AIM)
Time Frame: At post-operative visit (estimated to be at 3 months)
Validated survey which will be used per published scoring guidelines (8-40 with higher score meaning greater acceptability.
At post-operative visit (estimated to be at 3 months)
Appropriate expectation setting as measured by the Intervention Appropriateness Measure (IAM)
Time Frame: At post-operative visit (estimated to be at 3 months)
Validated survey which will be used per published scoring guidelines (8-40 with higher score meaning greater appropriateness.
At post-operative visit (estimated to be at 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Justin M Sacks, M.D., MBA, FACS, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202503134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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