Recruiting

DIEP Video

Sponsor:

Washington University School of Medicine

Code:

NCT06864754

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

WashU DIEP Flap Video

Study Details

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

Study ID

NCT06864754

Start date

Jul 18, 2025

Status verified date

Nov, 2025

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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).

Interventions

WashU DIEP Flap Video

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

Primary outcome measure

  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

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

314-362-7388jmsacks@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

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

314-362-7388jmsacks@wustl.edu

Principal Investigator:

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

More Information

Sponsor

Washington University School of Medicine

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-11-24.