WashU DIEP Flap Video and Patient Understanding Improvement

NCT06864754 | Recruiting

• 1 other identifier: 202503134
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Pre-operative anxiety; Patient understanding; Breast reconstruction; DIEP flap

Outcome Measures

Primary Outcomes (2)

• Change in understanding as measured by the Comprehension Assessment

  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)

  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 Outcomes (3)

• Appropriate expectation setting as measured by The Patient Education Materials Assessment Tool (PEMAT)

  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)

  At post-operative visit (estimated to be at 3 months)

• Appropriate expectation setting as measured by the Intervention Appropriateness Measure (IAM)

  At post-operative visit (estimated to be at 3 months)

Study Arms (1)

WashU DIEP Flap Video

EXPERIMENTAL

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

Interventions

WashU DIEP Flap Video OTHER

Video uses visual cues and graphics to help explain complex procedures in a simplified, comprehensible fashion to patients.

WashU DIEP Flap Video

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Justin M Sacks, M.D., MBA, FACS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin M Sacks, M.D., MBA, FACS

CONTACT

314-362-7388; jmsacks@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)